Articles on Lymphedema
Nature
Published
online: 27 July 2005; | doi:10.1038/436456a
Lymphatic system: Unlocking the
drains
Phyllida Brown
After centuries of playing second fiddle to the
blood system, our lymphatic circulation is coming into its own
as a
key player in diseases ranging from cancer to asthma. Phyllida Brown
reports.Circulation warWe are all
familiar with the blood
circulatory system. But its 'twin', the lymphatic system has been neglected in
the past.
Not now though, as cancer biologists, developmental
biologists and even palaeontologists begin to show that
it has many
vital functions
Sometimes it's hard to be a scientist. Just five years ago,
Mihaela Skobe, a molecular biologist now at
Mount Sinai School of
Medicine in New York, and her team were struggling to publish their work on the
lymphatic system. Editors and reviewers thought it boring. The
polite but yawning rejection letters came.
"They would say that
everything in the paper was fine but that lymphatics were unimportant," says
Skobe.
"There was a complete lack of interest."
Not any more.
Once dismissed as a mere drainage network, the body's 'second circulation'
system (see
Graphic, below) is emerging as a crucial player in
numerous diseases from cancer to asthma, and as a vital
part of the
normal immune system. As a result of these discoveries, researchers are trying
to intervene in its
activities, for example to reduce the spread of
tumours, to boost the efficiency of vaccines, or to treat the
painful and disfiguring swelling known as lymphoedema.
"It's a hot
field now," says Michael Detmar, a dermatologist and lymphatic system
researcher at Harvard
Medical School in Boston, Massachusetts.
These days, he says, many laboratories are switching from the
study
of blood vessels to the lymphatic system. Detmar is one of several researchers
showing how important
the lymphatic system is for tumour spread.
Other groups are finding it plays a key role in inflammatory
diseases such as asthma or transplant rejection. "We are in the
pioneering phase," says Detmar. "There is a
feeling that there is
still so much to discover."
Mystery vessels
It might seem strange that
one of the body's major organs is terra incognita. Lymphatic vessels may be
drains, but they are pretty sophisticated ones. Not only do they collect
fluid that has leaked into tissues from
the bloodstream and return
it to the blood; they also process that fluid, sending it through lymph nodes
where key cells of the immune system, called dendritic cells,
present fragments of foreign molecules to other
cells to mount an
immune response.
But the fact is that the lymphatic system has played second
fiddle to the blood system for centuries. Only
properly discovered
in the 1600s (see A brief history of our second circulation), it faded into
obscurity and,
apart from a brief flurry of interest around 1900,
was largely neglected until about ten years ago.
The turning point came in
the early 1990s when Kari Alitalo, a cancer researcher at the University of
Helsinki, began studying a family of proteins involved in generating new
blood vessels. These proteins, called
vascular endothelial growth
factors, or VEGFs, stimulate the growth of cells lining blood vessels and
enable
new vessels to sprout. Tumours often subvert these signals to
build a blood supply that nourishes their
invading mass. Like other
scientists, Alitalo reasoned that if these signals, or the receptor proteins
that enable
cells to receive them were blocked, blood vessels could
be prevented from growing, and tumours could be
starved to
death.
But what Alitalo and his team discovered next was to lead their focus
away from blood-vessel growth
signals and into the backwater of the
lymphatic system. He and his team happened upon a new VEGF
receptor
that was present mainly on the cells that line the insides of lymphatic
vessels1. The receptor was
similar to a known receptor for VEGFs
but neither of the two members of this family, VEGF-A or VEGF-
B,
activated it. So the hunt for the signal was on.
High hopes
When
they eventually found this signal, they discovered that it was an endothelial
growth factor similar to the
known VEGFs. They named it VEGF-C and
the receptor VEGF receptor 3 (ref. 2). In mice that had been
genetically engineered to express excessive amounts of VEGF-C, the
lymphatic vessels proliferated but —
crucially — the blood vessels
did not. This was the first signal known to act specifically on the lymphatic
system3. Meanwhile, on the other side of the world, Marc Achen and
Steven Stacker at the Ludwig
Institute for Cancer Research,
Melbourne, were hunting for further VEGFs. Faxes flew from Melbourne to
Helsinki and back. Together, the researchers soon identified another
signal that also acted on VEGF
receptor 3. This one was dubbed, not
surprisingly, VEGF-D (ref. 4).
"It was very exciting," says Alitalo. He and
the Australians hoped that their discoveries could eventually lead
to treatments to help build new lymphatic vessels in people suffering
from lymphoedema — for example
after breast cancer surgery.
But
progress was hampered by the fact that there were no 'markers' for the
lymphatic system. These are
proteins characteristic of the tissue
being studied that scientists use to specifically target dyes, and so to see
the tissue more easily. It was not until 1999, when David Jackson,
a biochemist at the Weatherall Institute of
Molecular Medicine in
Oxford, discovered such a marker, a protein called LYVE-1 (ref. 5), that
lymphatic
research really went into orbit.
For one thing,
researchers could now probe the role of the lymphatic system in the spread of
cancerous
tumours. Many tumours, such as breast cancer and
melanoma, spread from the original tumour via the
lymphatic system
to other organs, and a person's prognosis is worse if lymph nodes are involved.
Yet,
although the role of blood vessels in tumour spread had been
well studied, researchers knew almost nothing
about whether tumour
cells actively persuaded lymphatic vessels to grow and assist their spread or
whether
lymphatics were just passive ducts.
Alitalo's group,
together with Michael Pepper at the University of Geneva Medical Centre, and
Gerhard
Christofori at the Research Institute of Molecular
Pathology in Vienna, created genetically engineered mice
that
developed tumours in the pancreas and had abnormally high levels of VEGF-C in
the same organ. The
team found lymphatic vessels sprouting in the
animals' tumours. What is more, the animals' lymphatic vessels
often
contained tumour cells that had originated in the pancreas6.
Other teams
also found evidence pointing the finger at the lymphatic system as an active
agent in spreading
tumours. Detmar and Skobe transplanted human
breast cancers, engineered to make a lot of VEGF-C, into
mice, and
found lymphatic vessels sprouting within the transplanted tumours. Indeed, the
greater the degree
of lymph-vessel growth, the more the tumours
spread in the animals' lymph nodes and lungs7.
There is now little doubt
that this interplay between tumours and the lymphatic system is the main route
used
by solid cancers to spread. But could clinicians one day
intervene to stop it? Quite possibly. Stacker and
Achen and
colleagues from Melbourne showed that VEGF-D was, like VEGF-C, capable of
triggering
lymphatic vessels to grow inside transplanted tumours in
mice. It also increased the spread of tumours to
lymph nodes. But
when VEGF-D was blocked, this increased spread could be checked8
Alitalo's
group meanwhile, showed that mice genetically engineered to have VEGF-C and
VEGF-D
signalling blocked could not make new lymphatic vessels;
their existing vessels even shrank9. The team then
blocked VEGF-C
and VEGF-D signalling in mice with human-breast-tumour transplants, and found
it could
reduce the amount of tumour spread by two-thirds10. The
implications were clear: if VEGF-C and VEGF-
D could be blocked in a
mouse, then perhaps they could also be blocked in people with cancer to help
prevent tumour spread.
Mice to men
Evidence shows that
tumours in people behave like those in mice. Across a range of different human
tumours, those that contain high levels of VEGF-C or VEGF-D are
more likely to spread11. As a general
rule, the more lymphatic
vessels there are in the tumour, the greater the risk. Stacker and Achen are
hopeful
that trials testing agents that block VEGF-C and VEGF-D can
begin soon. After all, points out Achen, an
antibody called
bevacizumab, or Avastin, that slows the growth of blood vessels in spreading
colon cancer
by blocking VEGF-A, has already prolonged some
patients' lives.
But Alitalo warns that such trials may be a long time
coming. One problem, he says, is that tumour spread
can be a slow
process, and pharmaceutical companies are wary of embarking on costly trials
that take as
long as three years to reveal results.
As if all
this were not news enough, it seems that the lymphatic system has been hiding
an even bigger
surprise up its sleeve. Over the past year, several
research teams have begun to uncover evidence that the
lymphatic
system could be a major culprit in unwanted inflammation. Inflammation plays a
key role in
asthma, which affects an estimated five million people
in Britain alone. It is also associated with other
common
conditions including psoriasis and rheumatoid arthritis, and with some medical
problems such as
transplant rejection.
Dontscho Kerjaschki, a
pathologist at the Medical University of Vienna, has been studying what happens
when kidney transplants are rejected. Normally, the kidney cortex,
the part that filters blood, has hardly any
lymphatic vessels. But
in about a third of biopsies from transplanted kidneys, Kerjaschki found a
50-fold
increase in the number of lymphatic vessels12. In most
cases, such biopsies came from patients with chronic
rejection, a
condition in which the graft continues to be attacked by the host's immune
system after initial
immunosuppression treatment, until the
transplant breaks down. Kerjaschki thinks the unusually extensive
lymphatics could be involved, speculating that they may bring a
continual supply of immune cells into the
graft. "Maybe the
lymphatics are organizing the whole catastrophe," he says.
Hints that the
lymphatics can mastermind an immune response come from the discovery of a
protein called
podoplanin by Kerjaschki's team. Podoplanin sticks
to a signalling mol-ecule called CCL21, which is found
mainly in
lymphatic vessels. CCL21 is a powerful attractant to immune cells such as
dendritic cells and
macrophages13. In kidney grafts, where some
inflammatory cells are already present, the complex of
CCL21 and
podoplanin breaks down, releasing CCL21 into the vessel, and so attracting
further
inflammatory cells.
Key controllers
Another piece of
the jigsaw implicating lymphatic vessels in harmful immune responses comes from
Donald
McDonald, a vascular biologist at the University of
California, San Francisco, and his colleagues. They have
studied a
mouse model of asthma. The animals' lungs are chronically infected with
Mycoplasma pulmonis, a
bacterial infection that produces swelling
of the mucous membranes, alterations to vessel linings and scarring
— all symptoms that resemble those of human asthma. McDonald's group
found that infected mice grew
additional lymphatic vessels in their
tracheas, and their airway blood vessels also proliferated. When the
team
treated the mice with antibiotics, the blood vessels shrank but the extra
lymphatic vessels persisted14.
"This was a surprise," says McDonald. He
speculates that the new lymphatic vessels help to set the lung up
for more rapid and accentuated immune responses to subsequent
infections, exacerbating inflammation. His
team is now looking at
the signalling molecules involved, hoping that it may eventually be possible to
manipulate the inflammatory immune responses to help control
asthma.
Back in Helsinki, where it all began, Alitalo is upbeat. He is happy
that there are still fundamental questions
to answer, including how
cancer cells move beyond the lymph nodes as they travel through the vessels to
distant organs, and how exactly tumour cells enter lymphatic
vessels in the first place. And Skobe? She and
her team are getting
to grips with the molecules in lymphatic vessels that are involved in tumour
spread.
Skobe is not giving away details of her latest work yet.
But when she does have new results to report, it
seems unlikely,
this time around, that the journal editors will need convincing.
1.
Kaipainen, A. et al. J. Exp. Med. 178, 2077–2088 (1993).
2. Joukov, V. et
al. EMBO J. 15, 290–298 (1996).
3. Jeltsch, M. et al. Science 276, 1423–1425
(1997).
4. Achen, M. G. et al. Proc. Natl Acad. Sci. USA 95,
548–553
(1998).
5. Banerji, S. et al. J. Cell Biol. 22, 789–801
(1999).
6. Mandriota, S. J. et al. EMBO J. 20, 672–682 (2001).
7. Skobe,
M. et al. Nature Med. 7, 192–198 (2001).
8. Stacker, S. et al. Nature Med.
7, 186–191 (2001).
9. M¨akinen, T. et al. Nature Med. 7, 199–205
(2001).
10. Karpanen, T. et al. Cancer Res. 61, 1786–1790 (2001).
11.
Achen, M. G., McColl, B. K. & Stacker, S. A. Cancer Cell 7,
121–127
(2005).
12. Kerjaschki, D. et al. J. Am. Soc. Nephrol. 15, 603–612
(2004).
13. Yoneyama, H., Matusuno, K. & Matsushimaa, K. Int.
J.
Haematol. 81, 204–207 (2005).
14. Baluk, P. et al. J. Clin. Invest.
115, 247–257 (2005).
15. Pullinger, B. D. & Florey, H. W. J. Pathol.
Bact. 45,
157–170
(1937).
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TRUNCAL
LYMPHEDEMA:
http://www.lymphnotes.com/article.php/id/149/
Truncal
Lymphedema
Introduction
Truncal lymphedema, which affects the chest
region, frequently develops following breast or lung cancer
treatment and can be present with or without significant involvement of
the adjacent arm.
Some studies suggest that up to 80% of women may develop
truncal lymphedema after certain breast
cancer diagnosis and
treatment procedures, yet the condition often remains undiagnosed or
treated.
Symptoms
Pain is a significant symptom of truncal lymphedema and
it usually affects the shoulder and chest wall. The
pain
accompanying truncal lymphedema is usually more severe than pain associated
with lymphedema of the
arm.
Anterior chest wall swelling is most
commonly located in the affected breast or on chest wall, over the
collarbone (area of the neck), in the axillary cavity (the area under
the arm), on the inner surface of the upper
portion of the adjacent
arm, and along the scar lines.
Swelling of the back usually appears as extra
rolls of fat along the side of the trunk, fullness over the
shoulder blades or upper back, and (if the right side is affected)
fullness across the waistline on the right side
of the
trunk.
Swelling of the arm may, or may not, be present. Differential
diagnosis of truncal lymphedema can be
difficult if the patient
does not also present with lymphedema of the upper
extremities.
Reconstruction complaints include that the reconstructed breast
is too large, misshapen, and uncomfortable
during the activities of
daily living.
Treatment Modalities
Manual lymph drainage is very
important in removing excess fluid, softening fibrotic tissues, and easing pain
in the area. Patients with truncal lymphedema may require frequent
visits for MLD treatment.
Photo Courtesy of Bellisse.
Compression
is difficult to obtain; however, the specialized Compressure Comfort Bra is
designed to meet
the compression needs in this area. It is also
designed to provide comfort in the underarm area where
swelling may
remain. Because this bra has a pocket to hold a prosthesis, insurance will
often pay for this
garment under the terms of the Women’s Health
and Cancer Rights Act.
Specialized quilted compression pads are available to
be worn under a bra. These aids encourage lymph
drainage and help
to soften fibrotic tissue. These are available from several manufacturers and
are often
custom made to fit the areas of greatest
need.
Bandaging is of limited value on the chest for two reasons: First,
bandages are designed to work with the
pumping action of muscles
and this kind of muscle action is not present in the chest. Second, because of
the
constant changes in chest size while breathing, it is difficult
to bandage effectively and to keep these
bandages in
place.
Exercise is particularly important in managing truncal lymphedema.
The movements of muscles and the
flexing of joints stimulate the
flow of lymph and stimulate natural drainage. Exercises in chest deep water is
particularly important because the pressure of the water provides
compression over the entire affected area.
See Aquatic
Therapy.
Self-Massage is extremely important in managing truncal lymphedema
because it helps to compensate for
the difficulty in obtaining
compression. Self-massage should be performed regularly as recommended by
your lymphedema therapist.
Avoiding a Tourniquet Effect
The term
"tourniquet effect" is used to describe any garment that blocks or slows lymph
drainage. You can
take steps to avoid such damaging areas of
blockage.
Courtesy of
Bosom Buddy.
Avoid a heavy prosthesis. A
heavy prosthesis places pressure against the chest wall, but not where you want
compression. It also drags on the bra straps. Wearing a light-weight
prosthesis can ease this problem.
Avoid narrow bra straps. Bra straps that
dig into the shoulders block the flow of lymph at the terminus.
Wearing a bra with wide padded straps, such as those on the Compressure
Bra shown above, eases this
problem.
Avoid an underwire bra.
This type of bra is not recommended for anyone who has had breast cancer
treatment and is at risk of developing lymphedema
Avoid constriction
around the chest. If the lower band of a bra band is too tight, and without
elasticity, it
blocks the flow of lymph. Therefore the bra band
should be wide and flexible.
Avoid constriction around the waist. This
includes tight waistbands on clothing and long-line bras. They have
a girdle-like effect around the waist that blocks the flow of
lymph.
References
For more photographs and information about truncal
information read the Bellisse article “What Does
Truncal Lymphedema
Look Like?”
Living Well with Lymphedema by A. Ehrlich, A, Vinjé-Harrewijn
PT, CLT, and E. McMahon PhD. Lymph
Notes. 2005, pages
41-42.
Truncal Lymphedema by E. Muscari-Lin, RN, MSN. APRN, BC, AOCN. Lymph
Link, Vol 16, No 1,
January-March 2004.
LymphNotes.This
information does not replace the advice of a qualified health care
professional.
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http://www.lymphnotes.com/article.php/id/250/
Lymphatic
Malformations
Introduction
Lymphatic malformations are rare conditions in
which there is abnormal prenatal development of the
lymphatic
system that can affect any body part. These conditions, which often can be
detected on prenatal
ultrasounds, cannot be cured.
What are
Lymphatic Malformations?
A lymphatic malformation is a rare condition in
which abnormal prenatal development of the lymphatic
system results
in tumor-like formations that can occur in the skin and in just about any
portion of the body.
The most common locations are in the face,
neck, torso, groin and the extremities. They can also occur in
the
intestines, abdominal cavity and even in bones.
Lymphatic malformations are
commonly disfiguring and often associated with other medical problems. The
children and their families face medical problems, emotional
difficulties and the isolation that comes with
having such a rare
condition.
C.A.L.M., an acronym for “Children Anguished with Lymphatic
Malformations,” is a support group that
was founded in 1993 to help
families afflicted with this rare and misunderstood disfiguring disorder. To
learn
more about this condition and the activities of the Stay Calm
organization visit the Stay Calm web site.
Intestinal
Lymphangiectasia
Intestinal lymphangiectasia, which is also known as
lymphangiectasis, is a fairly rare condition that affects the
digestive system and causes difficulties including constipation,
diarrhea, and abdominal pain.
According to medical dictionaries
lymphangiectasia means, “the dilation (expansion) of lymphatic vessels” or
“a malformation of lymphatic vessels.” To the families of children with
intestinal lymphangiectasia, this means
multiple hospital trips,
special diets, and surgeries to control this potentially life threatening
condition.
One side effect of intestinal lymphangiectasia is the development
of lymphedema in various parts of the
body. For example, we heard
from the mother of an eight year old son. He suffers from lymphangiectasia
and now has developed lymphedema in both legs, the right arm, abdomen,
scrotum, and penis.
To learn more about this condition, and how the families
affected by it manage, also visit these web sites.
http://littleleakers.com/
http://www2.caringbridge.org/ca/ironkidmike/
--------------------------------------------------
Lymphedema-Distichiasis
Lymphedema-Distichiasis
is an autosomal dominant disorder that classically presents as lower-limb
lymphedema and distichiasis which is a double row of
eyelashes.
Irritation of the cornea, with corneal ulceration in some cases,
brings the patients to the attention of
ophthalmologists. Other
complications may include cardiac defects, cleft palate, spinal extradural
cysts, and
photophobia.
This condition, which occurs primarily
in males, is transmitted by an autosomal dominant chromosome,
which
means that it can be transmitted when only one parent who has this
condition.
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http://www.lymphnotes.com/article.php/id/349/
Lumpy Jaw is
Not Part of Lymphedema
A dental abscess can cause
of "lumpy jaw" to
develop.
Introduction
Yes, there really is a disease known as lumpy jaw
and it is not related to lymphedema! However information
about this
condition may answer some of the questions we have received from visitors who
are worried
about swellings in the head and neck area.
The
medical name for this condition is actinomycosis and it is caused by the
bacteria actinomyces. These
bacteria are normally present in a
healthy mouth without causing any problems. An infection does not occur
unless these bacteria are introduced into the tissues of the mouth due
to an injury, a dental abscess, or oral
surgery.[1]
Important
These lumps are not swollen glands;
however, because infection is present in the area nearby lymph nodes
under
the jaw or along the neck can become swollen.
Signs and Symptoms
Once in
the tissues these bacteria form an abscess. This is usually a chronic condition
and there may be
several abscesses present that produce hard,
red-to-reddish-purple lumps either on exterior of the jaw bone
or on
the lower portion of the face. This is why the condition is known as lumpy jaw.
[2]
With the passage of time an abscess can form a fistula. Eventually this
breaks through the surface of the skin
and allows pus to drain out
of the abscess. Unfortunately just because it is draining does not mean that it
has
healed.
Treatment
Usually this condition is chronic
before it is diagnosed and then it often requires treatment for several weeks
with IV antibiotics and this is followed by months of oral
antibiotics. To speed healing, sometimes surgery is
performed to
open and drain the
abscess.
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http://www.lymphnotes.com/article.php/id/188/
Swollen Lymph
Nodes
Introduction
The term swollen glands, also known as lymphadenitis
or swollen lymph nodes, refers to an abnormal
enlargement of one or
more lymph nodes. Swollen glands are most commonly caused by an infection.
[1]
Swollen Glands and Lymphedema
Swollen glands are not a symptom of
lymphedema; however if you have lymphedema, and you develop
swollen
glands, this is most commonly a symptom of an infection. A lymphedema related
infection requires
prompt treatment including a diagnosis of the
cause of the swollen glands.
Additional Causes of Swollen Glands
In
addition to infection, other conditions that are associated with swollen lymph
nodes include:
an abscessed or impacted tooth
chronic fatigue
syndrome
ear infection
gingivitis
HIV or AIDS
Hodgkin's
disease
infectious mononucleosis
leukemia
mumps
non-Hodgkin's
lymphoma
rheumatoid arthritis
rubella
sexually transmitted
diseases
tonsillitis
tuberculosis
Shotty Lymph Nodes
Shotty lymph
nodes are clusters of small swollen lymph nodes that may occur when the immune
system is
reacting to an infection. These nodes are so named
because they feel like buckshot under the skin.
Who Treats Swollen
Glands?
When swollen glands occur, a primary care provider is consulted
first. Then, based on the patient’s
condition, a referral may be
made to the appropriate
specialist.
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http://www.lymphnotes.com/article.php/id/316/
When
Lymphedema Affects Your Hand
Introduction
Lymphedema that affects the arm
often also affects the hand. For some patients this is only a minor
inconvenience. For others it is a major problem that interferes with
the activities of daily living and even the
ability to continue
working.
What Happens
According to Christine Thomas LPT, CLT-LANA, a
member of the Lymph Notes Editorial Advisory
Board, “Most patients
with arm edema will also have some hand edema (NOT everyone, but most). The
reason for this is that gravity is constantly acting on the swelling,
pulling it to the lowest possible point. The
basic principle of
bandaging or wearing a compression sleeve is that it must provide more
compression at
the bottom than it does at the top (to help
counteract gravity, and boost the fluid up and out).
“When you wear just a
compression sleeve, the hand is left with no compression. Any fluid that is in
the
hand will not be able to move up and out because it will be
blocked by the compression that the sleeve
provides at the wrist.
Wearing just a sleeve without a glove will often make any hand swelling
worse.
“The natural solution is to add compression to the hand. When
bandaging, this begins at the fingers and
continues upward to the
shoulder. When wearing a compression sleeve, the best solution is to wear a
compression glove.
"There are companies that carry ready-made or
standard size gloves; however, the best fit and compression
are
usually gained with a custom made glove."
Compression Garments for the
Hands
Courtesy of Lymflo Therapies Inc.
Some manufacturers make a
sleeve and glove combination; however, except in the lightest weights, these
are very more difficult to put on and take off. For this reason the
sleeve and glove are usually worn as
separate garments.
The most
effective garment of hand compression is a glove with "finger stubs" that hold
the glove in place
and provide the more effective compression over
most of the hand.
Wearing a Gauntlet
Courtesy of Juzo USA.
Another option, is wearing a gauntlet such as the one shown here. This
leaves the fingers completely
exposed with only a "thumb stub" to
hold the glove in place.
This is more convenient because the fingers are
free; however, the compression is not as effective because
the
fingers are not covered. This means that any fluid trapped in the fingers will
stay there.
Courtesy of JoVi Pak.
Compression Aids for the
Hands
Compression garments are only worn during the day when you are active.
At night your therapist usually
recommends either bandaging or a
compression aid. These cover the hand. Shown here are bandages being
placed
over a compression aid. Notice that this covers the hand and
fingers.
Helpful Tips
Wearing a compression glove throughout the day can
get messy—particularly if your dominant hand is
involved; however,
there are steps that you can take to minimize the inconvenience.
Have two
gloves. This allows one to be worn while the other is being laundered. (You
don’t want to take
changes with infection due to dirty
gloves.)
Teach yourself to do more tasks with your non-affected hand. This
reduces the chance of getting the glove
dirty.
Keep inexpensive
plastic food handler gloves, in a large size, conveniently located where you
can readily put
on a glove before performing messy tasks such as
preparing food or cleaning up in the kitchen.
TRAMPOLINES
Trampolines
for lymphedema.....
After reading about the use of a mini-trampoline for
helping lymphatic circulation, (article cite listed below) I
asked
my lymphedema doctor about it. He said had heard of it working best for leg
lymphedema, but had
not heard anything about it particularly
helping arm or hand lymphedema. He was sure it wouldn’t hurt me to
try. So I started slowly, to see if it would help resolve my right hand
and arm lymphedema (LE), which had
not been responding well to
conventional treatment.
My mini-trampoline is about 40 inches in
diameter. I got it at a sporting goods store for $40. A friend of
mine keeps hers behind her couch when she’s not using it. I keep mine
near the TV. That way I can watch
part of a movie every day while I
exercise. It makes the time go much faster. And if I get busy, 2-15 minute
sessions count the same.
Five minutes a day is all I did to
start. I was told that doing too much, too fast, would leave me with flu-like
symptoms. I stayed at 5 minutes a day for at least a couple of
weeks, until I felt comfortable (I was
recuperating from chemo, with
significant neuropathy in my hands and feet, at the time; you may be able to
advance more quickly than I could then, just watch carefully to see
how you feel, as you increase time). I
kept a chair-back next to the
trampoline, at first, in case I needed support. It is possible to buy a
mini-
trampoline with a bar handle for support, if that would make
you feel safer. I happened to have this one
already here. I wear
shoes (and my orthotics) on the trampoline.
Pumping my arms and legs, I
walk in place on the trampoline. My feet never leave the surface of the
trampoline. It looks like an exaggerated race-walk stance. It is the
muscle-pumping action of the legs and
the arms that is so important
for draining the lymphatics. This is one of the reasons that walking is such
good
exercise. The difference for me is that I can easily talk
myself out of walking in bad weather, too hot or too
cold. With the
trampoline right here in my living room, I have fewer
excuses!
Increasing the time by 2 ½ minute increments, I spent about 3-4
months getting up to my present 30 minutes
a day. I just tried to
listen to how good, or how tired, I was feeling, and to take my time about it.
I do take
days off, most often when I am away from home (the
trampoline does not fit into the trunk of my car).
An added bonus is
that my weight has decreased, as my time on the trampoline has increased, which
also
helps LE! It is low-impact aerobic exercise. I have increased
my tempo as my endurance has grown. The
best part is that my
lymphedema is now under control, with hand and arm measurements as good, or
better,
than when I was first treated for LE. It is a simple,
inexpensive, weatherproof way to exercise for LE.
Trampoline Article: p.
110 Supernutrition For Menopause, Ann Louise Gittleman, Avery publishing Group,
1998.
Author: Cynthia Adams of the Marin Lymphedema
Information and Support
group.
----------------------------------------------------------------------
Living
Well with Lymphedema
by Ann B. Ehrlich, Alma Vinji-Harrewijn, Elizabeth J.
McMahon
Living Well with Lymphedema is the comprehensive resource for
those with, or at risk of developing,
lymphedema. This
easy-to-read, generously illustrated, 280 page book contains the information
necessary
to understand what is lymphedema, what causes it, how it
is treated, self-management steps to control your
condition,
practical suggestions on how to master the emotional challenges that accompany
living with a
chronic condition, plus an illustrated guide to
understanding the lymphatic
system.
----------------------------------------------
Massage
& Bodywork June/July 2005 page 18 states "The fear that touch modalities
will cause metastasis is
no longer an issue in the oncology
community, even if the bodywork has a circulatory or mechanical
aspect"
Tadpole to help in the fight against Lymphedema
Contact:
Ann Van Gysel
32-92-446-611
VIB, Flanders Interuniversity Institute of
Biotechnology
http://www.eurekalert.org/pub_releases/2005-08/vfii-tst081205.php
http://www.abreastinthewest.ca/active2.cfm?Num=61
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
ELYMPHNOTES
I'm
the new forums coordinator on ELymphnotes, drop by to say
hi!
http://www.elymphnotes.com/forums.asp?fn=dis&cn=qa
I'm also a
part of the LAF Community Network and will be around in chat to set up times to
talk to those
who need help, come to the Lymphland chatroom. I'm
also writing articles for ELymphNotes and was
interviewed by a
national magazine called Beyond which will come out in late May.
UNTIE
MASSAGE THERAPY TECHNIQUE:
UNTIE
UNTIE was developed in the United
States in the early 1980s as an alternative to exerting force into soft
tissues that may already be painful to the touch. It is basic to UNTIE
that soft tissue dysfunction, no matter
how deep within the body,
can be felt in the skin. These patterns of dysfunction are palpable once the
proper awareness and sensitivity have been developed. Patterns are
infinitely variable expressions of soft
tissue dysfunctions that
are synergistically related to the dysfunctions. The skilled practitioner can
readily
access even the deepest layers of soft tissue by working
with the associated patterns. Changes in the
patterns are
stimulated by the presence of the practitioner’s fingers and determined by the
body’s natural
desire to reach homeostasis. The fingers respond to
the changes without any application of force, will, or
preconceived
routine. The hands move gently in concert with the changes. Once the patterns
release, the
soft tissues are re-evaluated to confirm they have
normalized and musculoskeletal integrity has improved.
Although
other approaches may not specifically address soft tissue patterns, the
patterns are affected, since
there is contact with the skin as soft
tissues are manipulated. The more thorough the method used, the more
likely
it is that the patterns will be released, allowing for more complete, long-term
change. Because the
foundation of UNTIE is sensitivity, it readily
deals with the unique patterns of the individual. It is a procedure
for working “with” the body, not “on” the body.
In conjunction
with manual lymph drainage therapy, scar tissues can be helped dramatically.
More details
coming on this new therapy
technique....
---------------------------------------------------
Bubonulus
1. An abscess occurring along the course of a lymphatic vessel.
2. One
of a number of hard nodules, often breaking down into ulcers, which form along
the course of
acutely inflamed lymphatic vessels of the dorsum of
the penis.
Data Synopsis: Early Diagnosis and Treatment Intervention for
Lymphedema
By NL Stout Gergich, MPT and PW Soballe, MD, Breast Care Center,
National Naval Medical Center,
Bethesda, MD
LA Pfalzer, PT, PhD,
University of Michigan-Flint, Flint, MI
CL McGarvey, DPT, MS, National
Institutes of Health, Bethesda, MD, Physical Therapy
Dept
Relevance
2.3 million women are survivors of breast cancer
(BC)1.
Incidence of lymphedema (LE)
33% axillary lymph node dissection
(ALND) and radiation therapy (RT)2
14% after sentinel lymph node biopsy and
RT3
LE impacts quality of life; range of motion (ROM), strength and
function2
LE is a chronic condition that is progressive if
untreated
Diagnosing Lymphedema
Traditionally, the diagnosis of LE occurs
after the condition becomes clinically apparent resulting in delayed
treatment
and progression of the condition
Current Valid/Reliable Measurement
Techniques
Circumferential limb girth4
Water
displacement2&5
Infrared optoelectronic5
Bioimpedence devices
6&8
Early detection and treatment prevents the progression of LE to an
advanced stage
Purpose
To investigate the efficacy of a prospective PT
screening method to accurately diagnose sub-clinical
lymphedema and
to evaluate the effectiveness of an early intervention in patients recently
treated for breast
cancer
Methods
Design:
A subset
analysis of a cohort of women from a large IRB approved study*
Pre-operative
and follow-up bilateral arm volume measurements taken at 80% of limb length
measured from
ulnar styloid to tip of acromion at 1, 3, 6, 9, 12 and
18 months by optoelectronic volumeter (Perometer®)6
from
1999-2006.
Diagnostic Criteria:
34 women 34-85 years old (mean=55.4)
reported symptoms of LE including heaviness or increased limb
volume
Intervention was introduced if the volume change equated to
approximately 100 ml or 3% volume change
compared to the pre-op
inter-limb measures
Intervention:
Diagnosis of LE - a Jobst Ready-Made
Compression Class I sleeve and gauntlet issued for daily wear and
advised to follow up in 4-6 weeks
Volume assessment was repeated on
follow up
Upon confirmation of volume decrease, continued garment wear was
prescribed with
Strenuous exercise
Lifting
The appearance of visible
swelling
Sensations of heaviness, fullness, aching
Follow up in 3 months
for repeated measures
Results
Volume increase in the AA at intervention
was significant (p=0.001). Baseline to intervention averaged 6.9
mos.
A significant (p=0.0000) mean volume decrease of 111 ml (7.6%)
in the AA using the sleeve. Time to post
intervention avg= 4.4
weeks
Limb volume was maintained through follow up. Avg = 5.8
months
Conclusions
Pre-operative assessment, prospective surveillance and
early intervention may have prevented the onset of
irreversible LE
in this small cohort
The garment significantly reduced affected limb volume
to nearly that of the unaffected limb and therefore
provides
effective treatment when sub-clinical LE can be detected.
Further research
is warranted to confirm the long term effectiveness and cost effectiveness of
this preventive
model compared to a traditional impairment based
model.
References:
American Cancer Society (ACS). “Breast Cancer Facts
and Figures 2006.” Retrieved from the World
Wide Web on July 19,
2006 at http://www.cancer.org/downloads/STT/CAFF2005BrF.pdf
Petrek JA,
Pressman PI, and Smith RA. Lymphedema: current issues in research and
management. CA
Cancer J Clin. 2000
Sep-Oct;50(5):pp:292-307.
Haid A, Koberle-Wuhrer R, Knauer M, Burtscher J,
Fritzsche H, Peschina W et al. Morbidity of breast
cancer patients
following complete axillary dissection or sentinel node biopsy only: a
comparative evaluation.
Breast Cancer Res Treat 2002;
73(1):31-36.
Armer J, Radina M, and Culbertson S. “Predicting Breast
Cancer-Related Lymphedema Using Self-
Reported Symptoms.” Nursing
Research. Volume 52, No.6 (2003):pp. 370-379.
Hayes S, Cornish B, and Newman
B. “Comparison of methods to diagnose lymphedema among breast
cancer survivors: 6 months follow-up.” Breast Cancer Research and
Treatment. Volume 89 (2005):pp.221-
226.
Stanton AW, Northfied
JW, Holroyd B, Mortimer PS, and Levick, JR. Validation of an optoelectronic
limb
volumeter (Perometer). Lymphology. 1997 vol:30 (2): pp:77
-97.
Cheville AL, McGarvey CL, Petrek JA, Russo SA, Thiadens SR, Taylor ME.
“The Grading of
Lymphedema in Oncology Clinical Trials”. Semin
Radiat Oncol. 2003 Jul; 13(3): pp: 214-25.
American Cancer Society (ACS).
“Lymphedema: What Every Woman With Breast Cancer Should Know.”
Retrieved from the World Wide Web on July 01, 2006 at http://www.cancer.
org/docroot/MIT/content/MIT_7_2x_Lymphedema_and_Breast_Cancer.asp
*http://clinicaltrials.gov/ct/show/NCT00027118?order=5
DIURETICS -
HOW EFFECTIVE ARE THEY?
Reputable health authorities advise against
using diuretics in the treatment of lymphedema pointing out that
the therapy is generally not effective and can be damaging when used
over a long period of time:
The Canadian Medical Association Journal,
Clinical practice guidelines for the care and treatment of breast
cancer: 11. Lymphedema (CMAJ 2001;164(2):191-9) released in January of
2001 by Susan R. Harris,
Maria R. Hugi, Ivo A. Olivotto, Mark
Levine, for the Steering Committee for Clinical Practice Guidelines
for the Care and Treatment of Breast Cancer notes:
Diuretics, which
have been recommended in the past, may temporarily mobilize water, but the
increased
interstitial oncotic pressure exerted by the high protein
concentration of lymph fluid will cause rapid
recurrence of edema.
The diuretic effect in the rest of the body may cause adverse side effects,
such as
hypotension, dehydration and electrolyte
imbalance.
The National Cancer Institute (NCI) points out that, "
Diuretics encourage vascular fluid depletion, but do
nothing for
excess protein deposits and could hasten connective tissue fibrosis. Therefore,
diuretics should
be used with caution and only for treatment of
excess vascular fluid due to other causes (1998)".
The 1995 consensus
document of the International Society of Lymphology Executive Committee reports
that although diuretics may be occasionally be useful during the
initial phase of physiotherapy or in certain
unique medical
situations, their use on a long term basis is not generally effective.
"Long-term administration
of diuretics is discouraged as being of
marginal benefit and potentially complicated by fluid and electolyte
disturbances.".
Managing
your lymphedema takes time and practice. You're therapist will teach you how to
properly
bandage or wear compressions combined with self massage.
Practice makes perfect so have patience.
Although there is no cure and
lymphedema is usually progressive, we can hope for research and studies to
arise in the future to help those with the condition and also measure
to prevent others from ever having it.
Therapist Hygiene
If you have
open wounds or leaking fluid, your therapist may wear gloves. Gloves protect
contact with
fluids, substances, and chemicals. If working in the
mouth to drain nodes, a therapist will wear gloves. Be
sure if you
have any known allergy to latex you inform your therapist BEFORE bodywork with
gloves
We are called to be architects of the future, not its victims. ~ R.
Buckminster Fuller
Managing Lymphedema
At a Glance
Your doctor and
nurse are more likely to take your symptoms seriously and be attentive to your
progress if
they regularly measure the circumference of your arm and
compare it with your unaffected arm, documenting
the measurements
over time. You can usually control lymphedema by practicing good care and
following
basic guidelines.
The health care professionals who
specialize in the management of arm lymphedema are physical medicine
doctors
(physiatrists), physical therapists, and occupational therapists. But don't
assume that anyone in these
specialties is an expert in treating
lymphedema. Ask about experience and references before you let anyone
work
on your edema problem.
Most metropolitan areas have occupational or
physical therapists with practices dedicated to managing the
physical, psychological, and activity-related side effects of breast
cancer treatment. If you can't find a
therapist who specializes in
breast cancer, look for a general occupational or physical therapist in a
rehabilitation center or department who has experience taking care of
women with breast cancer
Title: Early Intervention and Treatment
Intervention for Lymphedema
Authors: Gergich N,1 Washington F,2 Pfalzer3 L,
Soballe P1 and McGarvey C4
Affiliations: 1. Breast Care Center, National
Naval Medical Center, Bethesda, MD.
2. University of Maryland School of
Medicine, Baltimore, MD.
3. University of Michigan-Flint, Flint,
MI.
4.National Institutes of Health, Bethesda, MD, Physical Therapy
Dept.,
Abstract:
DESIGN: This observational (case-control) outcome study
investigated the frequency
and severity of morbidities in a population of
approximately 165 patients diagnosed with
breast cancer before and after
medical and surgical treatment.
METHODS: A subset analysis of a cohort of
women of women diagnosed with subclinical
lymphedema (LE) was conducted.
Pre-operative and follow-up arm volume
measurements taken at 80% of limb
length measured from ulnar styloid to tip of
acromion at 1, 3, 6, 9, 12 and
18 months by optoelectronic volumeter (Perometer®) from
2001-2006.
Quantitative girth measurements were collected over this period using
an
optoelectric limb volumeter. The device is an framed infrared scanning
system
(Perometer, Pero-system MeBgerate GmbH, Wuppertal, Germany). This
instrument was
designed specifically to measure girth (cm) and volume (ml)
of the upper or lower
extremities and has been validated for use in a
clinical environment by Stanton1 and
others.
ANALYSIS: 2-way Repeated
ANOVA with Time and Limb as factors and mean values
calculated for Affected
and Unaffected Arms.
RESULTS: 43 women 34-82 years old (mean =55.3 + SD
12.1) reported symptoms of
LE including heaviness or increased limb volume.
Intervention was introduced if the
volume change equated to approximately
100 ml or 3% volume change compared to preop
measure. At intervention the
volume increase in the affected arm was significant (83.0
ml + 118.8 [2.1 %
+ 5.2] p=0.001). Baseline to onset of lymphedema and intervention
averaged
7.6 mos. Average time to follow up was 5.0 months, during which time
the
cohort demonstrated a significant (p=0.0000) mean volume decrease of
119.9 ml [8.6%]
in their affected arm by using the sleeve.
CONCLUSIONS:
Pre-operative assessment, prospective surveillance and early
intervention
may have prevented the onset of irreversible LE in this small cohort.
The
garment significantly reduced affected limb volume to nearly that of the
unaffected
limb and therefore provides effective treatment when sub-clinical
LE can be detected.
Further research is warranted to confirm the long term
effectiveness and cost
effectiveness of this preventive model compared to a
traditional impairment based model.
1. Stanton AW, Northfied JW, Holroyd B,
Mortimer PS, and Levick, JR. Validation of an
optoelectronic limb volumeter
(Perometer). Lymphology. 1997 vol:30 (2): pp:77 -97
The gold
standard treatment is a form of medical massage that can be
called:
Manual Lymph Drainage (MLD)
Lymph Drainage Therapy
(LDT)
Complete/Complex Decongestive Therapy (CDT)
The goal of therap is
to activate fluid circulation, to drain stagnant areas, stimulate the immune
system,
reduce pain, and keep muscle spasms to a minimum.
To
perform Lymphedema therapy, one must be certified and properly trained, look
for your therapists
credentials.
Therapy feels like a massage
only lighter. Your therapist will work on your body, usually head to toe.
He/she will drain the nodes which again, feels like a massage. The main
nodes are the waterwheel (behind
earlobe), clavicle (near
collarbone), axilla (under arms) and the iliac/inguinal nodes which are in the
abdomen. A good deal of time is spent going back and forth to the
main nodes to ensure good movement
of fluids. Extra time will be
spent on areas of swelling. Before you are worked on, the therapist will take
your medical history and measure your areas of swelling. This is
done so they can keep a record of how
you progress to a smaller
level.
You will be taught to perform self bodywork, how to care for your
skin, possibly skin brushing, do's and
don'ts, special exercises to
promote lymph flow, and how to wrap yourself. You usually are wrapped after
each session. After you maintain the same size for a period of
time, you will be ordered compression
garments (sleeve, stockings)
to wear instead of wraps.
When NOT to go to or schedule therapy
You
should not schedule or go to an appointment if:
You have active or acute
infections
You have a fever or inflammed red skin and possible
infection
Thrombosis (serious circulatory problems)
Major heart problems
(bodywork increases the cardiac load)
Bleeding
You are unable to
urinate
Also if you have any unexplained lumps or possible malignancies, you
need to check in with your doctor and
therapist. NEVER forget to
tell your therapist about any problems you are having, and ALWAYS have
your therapist update your health records to any new medications or
problems.
You should always have a current prescription for bodywork.
Most therapist will not treat you without a
referral.
ALWAYS
check your therapists credentials before you have bodywork done.
DIURETICS - HOW EFFECTIVE ARE THEY?
Reputable health authorities
advise against using diuretics in the treatment of lymphedema pointing out that
the therapy is generally not effective and can be damaging when
used over a long period of time:
The Canadian Medical Association
Journal, Clinical practice guidelines for the care and treatment of breast
cancer: 11. Lymphedema (CMAJ 2001;164(2):191-9) released in January of
2001 by Susan R. Harris,
Maria R. Hugi, Ivo A. Olivotto, Mark
Levine, for the Steering Committee for Clinical Practice Guidelines
for the Care and Treatment of Breast Cancer notes:
Diuretics, which
have been recommended in the past, may temporarily mobilize water, but the
increased
interstitial oncotic pressure exerted by the high protein
concentration of lymph fluid will cause rapid
recurrence of edema.
The diuretic effect in the rest of the body may cause adverse side effects,
such as
hypotension, dehydration and electrolyte
imbalance.
The National Cancer Institute (NCI) points out that, "
Diuretics encourage vascular fluid depletion, but do
nothing for
excess protein deposits and could hasten connective tissue fibrosis. Therefore,
diuretics should
be used with caution and only for treatment of
excess vascular fluid due to other causes (1998)".
The 1995 consensus
document of the International Society of Lymphology Executive Committee reports
that although diuretics may be occasionally be useful during the
initial phase of physiotherapy or in certain
unique medical
situations, their use on a long term basis is not generally effective.
"Long-term administration
of diuretics is discouraged as being of
marginal benefit and potentially complicated by fluid and electolyte
disturbances.".
Managing
your lymphedema takes time and practice. You're therapist will teach you how to
properly
bandage or wear compressions combined with self massage.
Practice makes perfect so have patience.
Although there is no cure and
lymphedema is usually progressive, we can hope for research and studies to
arise in the future to help those with the condition and also measure
to prevent others from ever having it.
Therapist Hygiene
If you have
open wounds or leaking fluid, your therapist may wear gloves. Gloves protect
contact with
fluids, substances, and chemicals. If working in the
mouth to drain nodes, a therapist will wear gloves. Be
sure if you
have any known allergy to latex you inform your therapist BEFORE bodywork with
gloves
We are called to be architects of the future, not its victims. ~ R.
Buckminster Fuller
Managing Lymphedema
At a Glance
Your doctor and
nurse are more likely to take your symptoms seriously and be attentive to your
progress if
they regularly measure the circumference of your arm and
compare it with your unaffected arm, documenting
the measurements
over time. You can usually control lymphedema by practicing good care and
following
basic guidelines.
The health care professionals who
specialize in the management of arm lymphedema are physical medicine
doctors
(physiatrists), physical therapists, and occupational therapists. But don't
assume that anyone in these
specialties is an expert in treating
lymphedema. Ask about experience and references before you let anyone
work
on your edema problem.
Most metropolitan areas have occupational or
physical therapists with practices dedicated to managing the
physical, psychological, and activity-related side effects of breast
cancer treatment. If you can't find a
therapist who specializes in
breast cancer, look for a general occupational or physical therapist in a
rehabilitation center or department who has experience taking care of
women with breast cancer
Title: Early Intervention and Treatment
Intervention for Lymphedema
Authors: Gergich N,1 Washington F,2 Pfalzer3
L, Soballe P1 and McGarvey C4
Affiliations: 1. Breast Care Center, National
Naval Medical Center, Bethesda, MD.
2. University of Maryland School of
Medicine, Baltimore, MD.
3. University of Michigan-Flint, Flint,
MI.
4.National Institutes of Health, Bethesda, MD, Physical Therapy
Dept.,
Abstract:
DESIGN: This observational (case-control) outcome study
investigated the frequency
and severity of morbidities in a population of
approximately 165 patients diagnosed with
breast cancer before and after
medical and surgical treatment.
METHODS: A subset analysis of a cohort of
women of women diagnosed with subclinical
lymphedema (LE) was conducted.
Pre-operative and follow-up arm volume
measurements taken at 80% of limb
length measured from ulnar styloid to tip of
acromion at 1, 3, 6, 9, 12 and
18 months by optoelectronic volumeter (Perometer®) from
2001-2006.
Quantitative girth measurements were collected over this period using
an
optoelectric limb volumeter. The device is an framed infrared scanning
system
(Perometer, Pero-system MeBgerate GmbH, Wuppertal, Germany). This
instrument was
designed specifically to measure girth (cm) and volume (ml)
of the upper or lower
extremities and has been validated for use in a
clinical environment by Stanton1 and
others.
ANALYSIS: 2-way Repeated
ANOVA with Time and Limb as factors and mean values
calculated for Affected
and Unaffected Arms.
RESULTS: 43 women 34-82 years old (mean =55.3 + SD
12.1) reported symptoms of
LE including heaviness or increased limb volume.
Intervention was introduced if the
volume change equated to approximately
100 ml or 3% volume change compared to preop
measure. At intervention the
volume increase in the affected arm was significant (83.0
ml + 118.8 [2.1 %
+ 5.2] p=0.001). Baseline to onset of lymphedema and intervention
averaged
7.6 mos. Average time to follow up was 5.0 months, during which time
the
cohort demonstrated a significant (p=0.0000) mean volume decrease of
119.9 ml [8.6%]
in their affected arm by using the sleeve.
CONCLUSIONS:
Pre-operative assessment, prospective surveillance and early
intervention
may have prevented the onset of irreversible LE in this small cohort.
The
garment significantly reduced affected limb volume to nearly that of the
unaffected
limb and therefore provides effective treatment when sub-clinical
LE can be detected.
Further research is warranted to confirm the long term
effectiveness and cost
effectiveness of this preventive model compared to a
traditional impairment based model.
1. Stanton AW, Northfied JW, Holroyd B,
Mortimer PS, and Levick, JR. Validation of an
optoelectronic limb volumeter
(Perometer). Lymphology. 1997 vol:30 (2): pp:77 -97
This page is a mix of
content from Lymphology magazine in the last article, exerpts from Dr. Chikly's
book,
Silent Waves, and additions from Tina Budde. Dr. Chikly's
information can be found on the many pages of
the site dedicated to
him, such as History of Lymph 1, 2, and 3, and Dr. Chikly. Information here is
used
with Dr. Chikly's consent.
Information on this page was
listed and edited by the Lymphland Editorial Team on January 1,
2008.
--------------------------------------
"Expert Patients"
With Fibromyalgia and Other Chronic Illnesses: Not Quite What the Doctor
Ordered
ImmuneSupport.com
08-10-2005
Few GPs support a
new initiative that aims to empower the sick. Cassandra Jardine meets two
long-term
sufferers who argue that the medical profession has
nothing to fear.
Lillian Balliston: Fibromyalgia patient
When Lillian
Balliston was in her early twenties, she suffered a knock on the knee. It
appeared to be a minor
injury, but triggered terrible pains. Unable
to wash or dress herself, she had to give up her job in personnel
and move back to her mother's home. Sometimes, in the street, the pain
was so bad that she would fall over
and, even now, 15 years later,
she is still so sore that she can't let her eight-year-old daughter, Isha, hug
her.
But the worst aspect of her condition, she says, is that the
health professionals didn't listen to her.
"Whenever I went to the
doctor, I felt criticised: I was told that I shouldn't be in such pain, so I
must be
depressed and should get out more. A physiotherapist gave
me exercises to do but, when I said I couldn't
do them because of
the pain, I was told to make more effort. I was made to feel as if I was the
problem
and, eventually, I began to doubt myself so much that I was
scared I would have to go into a mental home."
It was only in 1999 that
a rheumatologist diagnosed fibromyalgia, a form of arthritis that strikes the
muscles,
rather than the joints. "I broke down in tears when he
told me. I was so relieved that I wasn't responsible for
my own
symptoms," says Balliston.
To understand the condition, one UK website
suggests that you take the muscle that leads from your
shoulder to
your neck in your hand and squeeze hard; that's what it feels like all over the
body, all the time.
Living with that pain is miserable, but
Balliston feels that her frustration with doctors and physios made her
symptoms worse and that, because of self-doubt, she led an even more
restricted life than she need have
done. "If only there had been an
Expert Patient Initiative in the early 1990s, my life could have been so
different," she says.
The NHS's Expert Patient Initiative is
designed to give patients with chronic disorders - some 17 million
people; a third of the population - more control over their treatment.
Balliston signed up for it when she read
of a pilot scheme in her
GP's surgery in White City, west London. The course involved six sessions of
two
and a half hours, covering exercise, diet and complementary
therapies to how to communicate with health
professionals.
Perhaps it is this last element of the course
that accounts for doctors' lack of enthusiasm for the initiative.
Only 21 per cent of GPs surveyed were in favour; more than half
predicted that it will mean more work.
Perhaps they envisage
stroppy patients storming into the surgery and demanding the latest, very
expensive
drug, which the doctor doesn't think
suitable.
Certainly, an element of patient empowerment lay behind the
initial idea, which was developed by Kate
Lorig, a professor at
Stanford University in California. In the 1970s, while working with arthritis
patients, she
was shocked by the paternalism of doctors. Suffering
from a metabolic disorder herself, she developed the
self-help
course for patients, which has been adapted for Britain.
James Locke:
Ill for 21 years
James Locke was one of the first chronic invalids to
take it. A health administrator who was diagnosed with
HIV in 1984,
he has had 21 years to discover what it is like to live with his condition: the
pills that have
undesirable side effects, the near-death moments,
the isolation and the patches of despair. Now working as
an unpaid
tutor on the expert patient courses, he has discovered that whatever the
illness - diabetes, heart
problems, cancer, kidney failure or MS -
everyone's experience is much the same.
"The first time a group meets,
there is a powerful emotional moment," he says. "Each person has to introduce
themselves, their illness and explain how it affects their life.
For some, it will be the first time they have been
so open, but
they soon find that the others share the same feelings of anger, fear and
frustration."
Chronic conditions often mean the end of dreams, a loss of
motivation and a sense of being out of control,
he explains. "On
these programmes, we encourage people to dream again. Everyone has to set a
goal each
week and an action plan for achieving that goal. If
someone is unable to get there - many overestimate
themselves to
begin with - the group looks at solutions."
Locke found that becoming an
expert patient didn't mean becoming better informed about therapies and
treatments - he had always kept abreast of developments. Nor did it
mean going to see his doctor more
often. The impact lay in a
reduction of feelings of isolation and the realisation that he could make
himself
think more positively. "On those days when it's cold and
wet, instead of hiding in bed, I might now say to
myself: 'It's a
great day for the cinema.'"
The course made an even greater difference
to Lillian Balliston. "I was a mess," she says. "I was scared of
my
emotions because I felt that, if I expressed them, it would be further evidence
that I was losing my mind.
When I started going to expert patient
meetings, all that disappeared. I'm still disabled, but I don't feel so
bothered any more, because I know my condition has nothing to do with
my personality. I've realised how
much life I still
have."
Since taking the course, Balliston goes out more, often with a
colleague from the course to give her
confidence. She has read up
about fibromyalgia and her other problem, chronic pain syndrome, so she goes
to the doctor less regularly because she feels more in control. This
matches research that shows that expert
patients use their GPs, and
A&E and outpatients departments less than before; they are also more likely
to
take their medication.
Most important, Balliston has
learnt to talk to medical professionals: "Whenever I had an appointment, I
used to get upset and forget to ask questions that had been bothering
me. Now, I feel able to put those
feelings aside. I say: 'This is
what I've done and this is how I feel. Is there another direction you can point
me
in?'" That doesn't sound too scary for doctors. With the
initiative now expanding, Locke and Balliston hope
that more GPs
will realise that it is no bad thing if patients and doctors talk to each other
on a more equal
footing.
----------------------------------------
Help for
Lymphedema
By Rebekah Addy, Ivanhoe Health Correspondent
ORLANDO,
Fla. (Ivanhoe Newswire) -- The removal of lymph nodes is an important part of
breast cancer
surgery, but studies show between 5 percent and 50
percent of patients develop lymphedema, or swelling of
the arms,
from it. Now, one surgeon has developed a new procedure to prevent the painful
side effect.
V. Suzanne Klimberg, M.D., director at the University of
Arkansas for Medical Sciences, Favetteville,
developed a procedure
called Axillary Reverse Mapping (ARM), where doctors inject a blue dye in the
patient's arm, allowing them to clearly see where the lymph nodes
are located and enabling them to have
more precision, thereby
preventing lymphedema.
There are currently no other procedures available
to prevent lymphedema. "This is a big deal because it
should
prevent lymphedema because we haven't injured the lymph vessels coming out of
the arm," Dr.
Klimberg told Ivanhoe.
Dr. Klimberg says for
some patients, the pain of lymphedema can feel worse than getting a mastectomy.
Patient Pat Sharpitis got lymphedema after five years of battling
breast cancer. "I couldn't unbend my hand
-- it was so tight,"
Sharpitis told Ivanhoe. "I had to go through some heavy therapy. Now some of
the
swelling is down, but it's embarrassing sometimes."
Sharpitis has learned to live with it over the years saying, "It is a
sad thing. You can't wear jewelry on your
hands, and I was a jewelry
person."
The procedure can be done while in the operating room. Dr.
Klimberg recently presented her procedure at
the Society of Surgical
Oncology 60th Annual Cancer Symposium in Washington, D.C. Ethicon, a branch of
Johnson and Johnson has agreed to travel the country and present a
teaching seminar on ARM. Dr.
Klimberg and her colleagues are
looking into starting clinical trials to better understand ARM.
This
article was reported by Ivanhoe.com, which offers Medical Alerts by e-mail
every day of the week. To
subscribe, click on: http://www.ivanhoe.com/newsalert/.
SOURCE:
Ivanhoe interview with V. Suzanne Klimberg, M.D., University of Arkansas for
Medical
Science
--------------------------------
Guna-Lympho
Drug
name: Guna-lympho
Active Ingredients: Homeopathic
substances
Therapeutic actions: Guna-lympho works by activating
detoxification and micro-circulation functions.
By reducing the phlogosis of
the lymphatic system, Guna-lympho eliminates the lymphatic spasm that is a
cause of lymphatic stasis. Thus Guna-lympho reduces exudation and
lymphedema. Guna-Lympho possesses
not only lymphatic detoxification
function, but also anti-inflammatory and immune stimulating
properties.
Indications: Guna-lympho is used to treat the following
disease:
Lymphatic stasis (lymphedemas)
Inflammation of the lymphatic
organs (lymphadenitis, lymphangitis) ;
Hyperplasia or hypertrophy of the
lymphatic organs.
Extracellular matrix detoxification
Contraindications
and cautions:
Do not use Guna-lympho in allergy or hypersensitivity to any
of its active ingredients
Do not use Guna-lumpho in pregnancy and
breastfeeding
If you don't feel any improvement while taking Guna-lympho
within 5 days, stop using this medication
Use this medication with caution
in liver diseases
Adverse effects: There are possible side-effects
associated with this medicine that can affect individuals in
different ways. If a side effect is stated here, that does not
necessarily mean the fact that all people using
Guna-lympho will
experience it or any other.
allergic reactions: skin
rash
Hypersalivation
The side effects listed above may not include all of
the side effects reported by the drug's manufacturer.
For more information
about any other possible risks associated with Guna-lympho, please read the
information provided with Guna-lympho or consult your doctor or
pharmacist.
Interactions: It is important to tell your doctor or
pharmacist what medicines you are already taking,
including those
bought without a prescription and herbal medicines, before you start treatment
with Guna-
lympho. Similarly, check with your doctor or pharmacist
before taking any new medication while taking this
one, to ensure
that the combination is safe.
Additional Information: DO NOT SHARE
Guna-lympho with others. DO NOT USE THIS MEDICINE
for other health
conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed
during
treatment, out of the reach of children. Do not reuse
needles, syringes, or other
materials.
-------------------------------------------
Sources:
Data
Synopsis: Early Diagnosis and Treatment Intervention for Lymphedema
By NL
Stout Gergich, MPT and PW Soballe, MD, Breast Care Center, National Naval
Medical Center,
Bethesda, MD
LA Pfalzer, PT, PhD, University of
Michigan-Flint, Flint, MI
CL McGarvey, DPT, MS, National Institutes of
Health, Bethesda, MD, Physical Therapy Dept
NaturePublished online: 27
July 2005; | doi:10.1038/436456aLymphatic system: Unlocking the
drainsPhyllida Brown
Authors: Gergich N,1 Washington F,2 Pfalzer3
L, Soballe P1 and McGarvey C4Affiliations: 1. Breast Care
Center,
National Naval Medical Center, Bethesda, MD.2. University of Maryland School of
Medicine,
Baltimore, MD.3. University of Michigan-Flint, Flint,
MI.4.National Institutes of Health, Bethesda, MD,
Physical Therapy
Dept.,
The Canadian Medical Association Journal, Clinical practice
guidelines for the care and treatment of breast
cancer: 11.
Lymphedema (CMAJ 2001;164(2):191-9) released in January of 2001 by Susan R.
Harris,
Maria R. Hugi, Ivo A. Olivotto, Mark Levine, for the
Steering Committee for Clinical Practice Guidelines
for the Care
and Treatment of Breast Cancer notes.
----
25 February 2009 -
Identification Of Metastasis-Promoting Protein Could Provide A Prognostic Test
Or
Target For Breast Cancer
Tumors that are about to progress
and metastasize go through a process also seen in normal embryonic
development, known as the epithelial to mesenchymal transition (EMT).
Tumor cells revert to a less-
differentiated state, stop adhering to
each another and become more mobile and prone to invade and
proliferate. Now, researchers at Children's Hospital Boston show, for
the first time, that a small protein
called lipocalin 2 triggers
the EMT in human breast cancer - and that the same protein, when measured in
tissues and urine, can predict a cancer's invasiveness. Their
findings were published online February 23 by
the Proceedings of
the National Academy of Sciences.
Researchers led by Marsha A. Moses,
PhD, and Jiang Yang, PhD, of the Vascular Biology Program at
Children's, induced human breast cancer cells to make large amounts of
lipocalin 2, and showed that cell
motility and invasiveness
increased significantly. They then took cells from aggressive breast cancers
and
silenced lipocalin 2, and found that cell migration was
significantly inhibited. When they transplanted human
breast cancer
cells into animals, those from tumors making lipocalin 2 were more locally
invasive and more
likely to metastasize to lymph
nodes.
Further laboratory studies indicated that lipocalin 2 decreases
the levels of estrogen receptor alpha, thereby
reducing the cells'
response to the hormone estrogen, which is associated with poor prognosis of
breast
cancer. Inhibiting the production of estrogen receptor alpha
is also the mechanism that triggers the EMT
pathway, the
researchers show.
Finally, tissue samples, and even urine samples, from
women with invasive breast cancer consistently
showed elevated
lipocalin 2 levels, suggesting that testing for lipocalin 2 may be a way of
detecting cancer
progression and the need for more aggressive
treatment.
"Our study identifies a novel, additional player in the
complex development of invasive breast cancer," says
Moses, the
Vascular Biology Program's interim director. "It suggests that this protein may
represent a
prognostic and/or therapeutic target for this
devastating disease."
----------------------------
Article adapted by
Medical News Today from original press
release.
----------------------------
Lipocalin 2, along with other
urine biomarkers of cancer identified in Moses's lab, has been licensed to
Predictive Biosciences, Inc. (Lexington, Mass.) for clinical
development.
The study was funded by the National Institutes of Health,
the JoAnn Webb Fund for Angiogenesis
Research, the Riehl Family
Foundation, the S. Elizabeth O'Brien Trust and the Advanced Medical
Foundation.
Children's Hospital Boston is home to the world's
largest research enterprise based at a pediatric medical
center,
where its discoveries have benefited both children and adults since 1869. More
than 500 scientists,
including eight members of the National
Academy of Sciences, 11 members of the Institute of Medicine and
13
members of the Howard Hughes Medical Institute comprise Children's research
community. Founded as
a 20-bed hospital for children, Children's
Hospital Boston today is a 397-bed comprehensive center for
pediatric and adolescent health care grounded in the values of
excellence in patient care and sensitivity to the
complex needs and
diversity of children and families. Children's also is the primary pediatric
teaching affiliate
of Harvard Medical School. For more information
about the hospital and its research visit: http://www.
childrenshospital.org/newsroom.
Source: Rob
Graham
Children's Hospital Boston
21 February 2009 - Blood Testing
Identifies Abnormal Cells Up To Six Years Prior To Leukemia
Diagnosis
Testing of blood specimens may detect abnormal white blood cells
in patients years before the chronic form
of lymphocytic leukemia
(CLL) develops, according to research published in the current issue of the New
England Journal of Medicine. The finding may lead to a better
understanding of cellular changes that
characterize the earliest
stages of the disease and how it progresses.
Researchers at the National
Cancer Institute (NCI), part of the National Institutes of Health, and the U.S.
Food and Drug Administration, led the study, which was co-authored
by two researchers with Quest
Diagnostics Incorporated (NYSE: DGX),
Maher Albitar, M.D., Medical Director and Chief of Research
and
Development, Hematology and Oncology, and Wanlong Ma, M.S., Research and
Development
Manager, Hematology and Oncology.
For the study,
Dr. Albitar and Ms. Ma developed a method to identify abnormal B-cell clones in
blood
specimens. Quest Diagnostics plans to use a similar approach
to develop tests that may one day be used by
physicians as an aid
in identifying patients who will develop CLL.
"We searched for tumor
cells by performing a sophisticated form of flow cytometry as well as molecular
testing on frozen samples of whole blood and blood plasma," said
Dr. Albitar. "The findings of this study
lead to better
understanding of biological processes underlying the development of CLL, and
give us hope
that in the future we will be able to develop new
testing techniques to look at blood from patients with
abnormal
cells and distinguish those who will develop overt cancer from those who will
not."
"Quest Diagnostics is the leader in cancer testing, and this study
demonstrates the commitment of our
science and innovation team to
advancing cancer research," said Surya N. Mohapatra, Ph.D., Chairman and
Chief Executive Officer, Quest Diagnostics.
CLL is a blood
cancer that usually progresses slowly over many years. In this disease,
abnormal white
blood cells called B-cells accumulate in the blood
and the bone marrow. The lymph nodes, spleen, and
other organs may
also be affected. Although CLL is the most common form of leukemia in adults in
Western
countries, little is known about what causes the disease or
how it develops.
Previous research by the NCI/FDA team and others showed
that some family members of CLL patients can
have B-cells in their
blood that have outer-surface proteins that are similar to proteins found on
CLL cells.
This abnormal condition, known as monoclonal B-cell
lymphocytosis (MBL), occurs in over 10 percent of
CLL family
members and in about 3 percent to 5 percent of healthy adults over the age of
50, suggesting it
might be a precursor of CLL.
In the
current study, the research team identified 45 individuals among the more than
77,000 participants in
the nationwide Prostate, Lung, Colorectal
and Ovarian (PLCO) Cancer Screening Trial who were cancer-
free upon
entering the trial, were later diagnosed with CLL, and had frozen blood samples
available for
analysis that had been collected upon their enrollment
in PLCO. Using sophisticated laboratory techniques
developed by
Quest Diagnostics to analyze the blood samples, the researchers found that 44
of the 45 CLL
patients had MBL between six months to more than six
years prior to their CLL diagnosis. Prior research
shows that the
MBL cells were identified by examining cell-surface proteins, or CLL markers,
using a
method called flow cytometry, and by using molecular
techniques to confirm the presence of certain
rearranged genes,
known as immunoglobulin heavy variable (IGHV) group genes, found in CLL. In 41
patients, MBL was confirmed by both methods.
The study,
titled "B-Cell Clones as Early Markers for Chronic Lymphocytic Leukemia," (Vol.
360, No. 7,
Feb. 12, 2009) was accompanied by the editorial "The
Secret Lives of Monoclonal B Cells."
About Quest Diagnostics and
Blood-based Tumor Testing
Quest Diagnostics is a leader in noninvasive
blood-based biomarker testing used by physicians to screen for,
diagnose and monitor carcinomas and other tissue-based disease. The
company's proprietary Leumeta(TM)
portfolio of tests helps
physicians identify and analyze genetic components of leukemia and lymphoma
tumors using blood plasma instead of bone marrow, which can only be
tested after extraction through painful
biopsy. In addition, the
company is the exclusive national reference laboratory provider of the
blood-based
HE4 Ovarian Cancer Monitoring test, which is FDA
cleared as an aid in monitoring recurrent or progressive
disease in
women with epithelial ovarian cancer. The company is also developing a
molecular blood test
based on Epigenomics AG's Septin 9 DNA
methylation biomarker that can help physicians detect colorectal
cancer based on a patient's blood specimen.
About Quest
Diagnostics
Quest Diagnostics is the world's leading provider of
diagnostic testing, information and services that patients
and
doctors need to make better healthcare decisions. The company offers the
broadest access to
diagnostic testing services through its network
of laboratories and patient service centers, and provides
interpretive consultation through its extensive medical and scientific
staff. Quest Diagnostics is a pioneer in
developing innovative
diagnostic tests and advanced healthcare information technology solutions that
help
improve patient care. Additional company information is
available at http://www.questdiagnostics.com.
The statements in this
press release that are not historical facts or information may be
forward-looking
statements. These forward-looking statements involve
risks and uncertainties that could cause actual results
and
outcomes to be materially different. Certain of these risks and uncertainties
may include, but are not
limited to, competitive environment,
changes in government regulations, changing relationships with
customers, payers, suppliers and strategic partners and other factors
described in the Quest Diagnostics
Incorporated 2007 Form 10-K and
subsequent SEC filings.
Quest Diagnostics
http://www.questdiagnostics.com
20 February
2009 - Update On Lymphoma Drug Trial: Potential Breakthrough For T- Cell
Lymphoma
Patients With Drug That Mimics A Vitamin
Final results
of a pivotal Phase 2 clinical trial of pralatrexate (PDX) for patients with
relapsed or refractory
peripheral T-cell lymphoma (PTCL) were
reported by the study's principal investigator, Dr. Owen A.
O'Connor of the Herbert Irving Comprehensive Cancer Center at Columbia
University Medical Center and
NewYork-Presbyterian
Hospital/Columbia. T-cell lymphoma (PTCL) is a biologically diverse group of
blood cancers that account for as many as 15 percent of
non-Hodgkin's lymphoma (NHL) cases in the
United
States.
Data from the PROPEL (Pralatrexate in patients with Relapsed Or
refractory PEripheral T-cell Lymphoma)
trial show that
pralatrexate, a drug that partially works by mimicking the vitamin folic acid,
has an estimated
median duration of response of 287 days, or 9.4
months. As previously reported, 29 of 109 evaluable
patients, or 27
percent, showed a complete or partial response.
"Until now, these
patients could only expect to survive several weeks. This study shows that it
may be
possible to extend this to many months - a result that is
nothing short of spectacular and may likely represent
a
breakthrough in the development of new drugs for T-cell lymphoma," said Dr.
O'Connor, director of the
Lymphoid Development and Malignancy
Program and chief of the Lymphoma Service at the Herbert Irving
Comprehensive Cancer Center at NewYork-Presbyterian Hospital/Columbia
University Medical Center,
and associate professor of medicine at
Columbia University College of Physicians and Surgeons. "Based on
these promising data, pralatrexate has the potential to play a
clinically meaningful role in the treatment of
patients with
relapsed or refractory PTCL."
Pralatrexate, designed to look like the
natural vitamin folic acid, disrupts DNA synthesis in tumor cells. The
drug is designed to selectively accumulate in tumor cells, after which
it then induces programmed cell death,
or apoptosis, in the cancer
cell.
There are currently no pharmaceutical agents approved for use in
the treatment of either first-line or relapsed
or refractory PTCL,
and overall five-year survival is approximately 25 percent after first-line
therapy. In
addition to those PTCL patients who do not respond to
first-line treatment, a significant number of first-line
multi-agent
chemotherapy responders relapse or become refractory after
treatment.
The PROPEL trial is organized by Allos Therapeutics Inc., the
maker of the drug. The company expects to
submit a New Drug
Application to the U.S. Food and Drug Administration for marketing approval of
pralatrexate sometime in the first half of 2009. The results of the
trial will be submitted for presentation at an
upcoming scientific
meeting and for publication in a peer-reviewed journal.
Pralatrexate was
developed by a team of researchers at Memorial Sloan-Kettering Cancer Center
(MSKCC) and the Southern Research Institute, including Dr. O'Connor,
while at MSKCC. Dr. O'Connor
and his colleagues identified the
unique activity of pralatrexate in patients with lymphoma. Dr. O'Connor has
continued to study pralatrexate at NewYork-Presbyterian/Columbia, now
focusing on determining how the
drug works in T-cell lymphoma, and
on how best to combine it with other drugs to improve the treatment of
patient with hematologic cancers.
PROPEL Trial Details
The
critical PROPEL (Pralatrexate in patients with Relapsed Or refractory
PEripheral T-cell Lymphoma)
trial - an international, multicenter,
open-label, single-arm study - enrolled a total of 115 patients with
relapsed
or refractory PTCL, 109 of whom are considered evaluable for response according
to the trial
protocol. It is believed that PROPEL is the largest
prospectively designed single-agent trial conducted to
date for
this patient population.
To be eligible for the trial, patients' disease
must have progressed after at least one prior treatment. Patients
were considered evaluable if they received at least one dose of
pralatrexate and their diagnosis of PTCL
was confirmed by
independent pathology review. Patients received 30 mg/m2 of pralatrexate
intravenously
once every week for six weeks followed by one week of
rest per cycle of treatment. Patients also received
vitamin B12 and
folic acid supplementation. The primary endpoint of the trial is objective
response rate, as
assessed by central, independent oncology review
using International Workshop Criteria (IWC). Duration
of response
is the key secondary endpoint.
Of the 29 patients who achieved a
response according to central independent oncology review, 7 patients
had
a complete response (CR), 2 patients had a complete response unconfirmed (CRu)
and 20 patients had
a partial response (PR). According to the
PROPEL investigators, 42 of 109 evaluable patients, or 39
percent,
achieved a response. Of these, 15 patients had a CR, 4 patients had a CRu and
23 patients had a
PR. PROPEL patients received a median of three
prior systemic treatment regimens (range of 1 to 12),
including 18
patients, or 16 percent, who had previously undergone an autologous stem cell
transplant. In
the trial, 66 percent of the patients who responded
did so after cycle one of therapy. Patients will continue to
be
followed for long-term survival.
Peripheral T-Cell
Lymphoma
According to the American Cancer Society, approximately 66,000
patients are expected to be diagnosed
with non-Hodgkin's lymphoma
in the United States in 2009. Annual prevalence is estimated to be
approximately 9,500 patients. In addition to the 30 percent to 50
percent of PTCL patients that do not
respond to first-line
treatment, a significant number of first-line, multi-agent chemotherapy
responders
relapse or become refractory after
treatment.
NewYork-Presbyterian Hospital
NewYork-Presbyterian
Hospital, based in New York City, is the nation's largest not-for-profit,
non-
sectarian hospital, with 2,242 beds. The Hospital has nearly 2
million inpatient and outpatient visits in a year,
including more
than 230,000 visits to its emergency departments - more than any other area
hospital.
NewYork-Presbyterian provides state-of-the-art inpatient,
ambulatory and preventive care in all areas of
medicine at five
major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center,
NewYork-
Presbyterian Hospital/Columbia University Medical Center,
Morgan Stanley Children's Hospital of
NewYork-Presbyterian,
NewYork-Presbyterian Hospital/The Allen Pavilion and NewYork-Presbyterian
Hospital/Westchester Division. One of the largest and most
comprehensive health care institutions in the
world, the Hospital
is committed to excellence in patient care, research, education and community
service. It
ranks sixth in U.S.News & World Report's guide to
"America's Best Hospitals," ranks first on New York
magazine's
"Best Hospitals" survey, has the greatest number of physicians listed in New
York magazine's
"Best Doctors" issue, and is included among
Solucient's top 15 major teaching hospitals. The Hospital's
mortality rates are among the lowest for heart attack and heart failure
in the country, according to a 2007 U.
S. Department of Health and
Human Services (HHS) report card. The Hospital has academic affiliations
with two of the nation's leading medical colleges: Weill Cornell
Medical College and Columbia University
College of Physicians and
Surgeons. For more information, visit www.nyp.org.
Columbia University
Medical Center
Columbia University Medical Center provides international
leadership in basic, pre-clinical and clinical
research, in medical
and health sciences education, and in patient care. The Medical Center trains
future
leaders and includes the dedicated work of many physicians,
scientists, public health professionals, dentists,
and nurses at
the College of Physicians & Surgeons, the Mailman School of Public Health,
the College of
Dental Medicine, the School of Nursing, the
biomedical departments of the Graduate School of Arts and
Sciences,
and allied research centers and institutions. Established in 1767, Columbia's
College of Physicians
and Surgeons was the first institution in the
country to grant the M.D. degree and is now among the most
selective medical schools in the country. Columbia University Medical
Center is home to the largest medical
research enterprise in New
York City and state and one of the largest in the United States. For more
information, please visit
http://www.cumc.columbia.edu.
NewYork-Presbyterian Hospital
627 W
165th St., SB-621
New York
NY 10032
United States
http://www.nyp.org
14 February 2009 - gical Evaluation
Improves Women's Cancer Outcome
Many women scheduled to undergo hysterectomy
for pre-cancerous cell changes actually need a more
comprehensive
surgery, something they should discuss with a gynecologic oncologist, say
researchers at the
University of Alabama at Birmingham
(UAB).
If seen by a specialist, it should be recommended they undergo a
procedure that focuses on lymph nodes
and other organs not involved
in a traditional hysterectomy, said Warner Huh, M.D., a researcher at the
UAB Comprehensive Cancer Center.
The finding was presented at the
Society of Gynecologic Oncologists' 2009 Annual Meeting on Women's
Cancer in San Antonio.
"Given the high rate of endometrial
cancer, these data strongly suggest all women who have abnormal
bleeding and a diagnosis of pre-cancerous lesions of the uterus should
be evaluated by a gynecologic
oncologist," Huh said.
Huh and
his research team analyzed medical records of more than 3,322 patients treated
at seven
community hospitals across Alabama from 1999 to 2008. They
specifically looked women diagnosed with
pre-cancerous changes
called complex atypical hyperplasia (CAH).
Of patients who underwent a
traditional hysterectomy, about half were found to have invasive endometrial
cancer after their procedure. That means too many hysterectomy
patients should've had a more
comprehensive cancer surgery,
something a gynecologist oncologist is trained to do, Huh said.
To avoid
unwanted outcomes, women diagnosed with CAH should be referred to a gynecologic
oncologist
for evaluation, he
said.
----------------------------
Article adapted by Medical News
Today from original press
release.
----------------------------
Source: Troy
Goodman
University of Alabama at Birmingham
12 February 2009 - Bone
Marrow Transplant Patients May Benefit From New Immune Research
Many women
scheduled to undergo hysterectomy for pre-cancerous cell changes actually need
a more
comprehensive surgery, something they should discuss with a
gynecologic oncologist, say researchers at the
University of
Alabama at Birmingham (UAB).
If seen by a specialist, it should be
recommended they undergo a procedure that focuses on lymph nodes
and other organs not involved in a traditional hysterectomy, said
Warner Huh, M.D., a researcher at the
UAB Comprehensive Cancer
Center.
The finding was presented at the Society of Gynecologic
Oncologists' 2009 Annual Meeting on Women's
Cancer in San
Antonio.
"Given the high rate of endometrial cancer, these data strongly
suggest all women who have abnormal
bleeding and a diagnosis of
pre-cancerous lesions of the uterus should be evaluated by a gynecologic
oncologist," Huh said.
Huh and his research team analyzed
medical records of more than 3,322 patients treated at seven
community hospitals across Alabama from 1999 to 2008. They specifically
looked women diagnosed with
pre-cancerous changes called complex
atypical hyperplasia (CAH).
Of patients who underwent a traditional
hysterectomy, about half were found to have invasive endometrial
cancer after their procedure. That means too many hysterectomy patients
should've had a more
comprehensive cancer surgery, something a
gynecologist oncologist is trained to do, Huh said.
To avoid unwanted
outcomes, women diagnosed with CAH should be referred to a gynecologic
oncologist
for evaluation, he
said.
----------------------------
Article adapted by Medical News
Today from original press
release.
----------------------------
Source: Troy
Goodman
University of Alabama at Birmingham
Lymphoedema - PCT Funds
Research Into Treament Of Breast Cancer Side Effects Through Dragon Boat
Racing
NHS North Lancashire is funding groundbreaking research into
the benefits of the Chinese sport of dragon
boat racing in the
prevention of some of the distressing side-effects associated with breast
cancer treatment.
The Primary Care Trust (PCT) has awarded a
research bursary of £10,000 to researchers at Sheffield
Hallam
University in order to study the connection between physical activity and
breast cancer related
lymphoedema - an often distressing side effect
of breast cancer treatment.
The project is one of five being funded by
NHS North Lancashire in celebration of the NHS 60th birthday
this
year. Earlier this year the PCT announced that individuals or organisations
with an interest in conducting
research into innovative
improvements in health in the region could apply for a bursary and Dr Helen
Crank,
Senior Research Fellow at Sheffield Hallam University was
one of the successful applicants.
Dr Crank is using the bursary funds to
work closely with Paddlers for Life, a massively successful charity in
the region, who take to Windermere each week, and which is helping
cancer survivors regain their
confidence and health through dragon
boat racing, to investigate whether the sport can be an effective way
to
manage lymphoedema and improve the physical and psychological wellbeing of
breast cancer survivors.
The information gathered from this research
will be passed on to healthcare professionals and women and
men who
have been treated for breast cancer so as to help shape the future of exercise
and cancer
rehabilitation referral schemes.
Lymphoedema is a
condition characterised by swelling caused by a build up of lymph fluid in the
tissues.
Breast cancer related lymphoedema occurs as a result of
damage to the lymphatic system which can be
caused by breast
surgery and radiotherapy to the lymph nodes in the armpit and surrounding areas
such as
the neck or chest. Up to 40% of women who receive treatment
for breast cancer experience the condition.
Typically patients
experience swelling of the arm or hand on the surgical side, which can be
accompanied by
sensations of pain or heaviness, and so negatively
affecting survivor's quality of life.
Commonly, the advice offered to
women who suffer with breast cancer related lymphoedema recommends
only very gentle exercise and much caution, but dragon boat research
carried out in Canada suggests that in
fact more strenuous exercise
might play a vital role in recovery from breast cancer. The physical demands of
dragon boat paddling and related exercise training can improve
cardio-respiratory fitness, shoulder joint
range of movement and
muscle tone which all combine to assist lymph fluid propulsion and prevent
further
increases in arm swelling.
However, UK-based studies
must be carried out to understand how much and what type of training is
needed to gain health improvements and if the effects seen in Canada
can be achieved by breast cancer
survivors here in the UK. This
research programme will therefore be an important step in obtaining evidence
before exercise programmes such as dragon boat racing can formally
be offered by the NHS for breast
cancer survivors.
Ian
Cumming, Chief Executive of NHS North Lancashire, says: "We are very pleased to
be able to support
this worthwhile research project which will lead
to a better insight into the role of exercise in speeding
recovery
from breast cancer related lymphoedema.
"We hope that through funding
this research, more cancer survivors right across the UK can experience the
physical and mental benefits that team sports such as dragon boat
racing can provide.
"Funding research projects such as this is an ideal
way to celebrate the NHS 60th birthday: They will ensure
that new
insights and developments can continue to be made in healthcare in the
Lancaster, Fylde and Wyre
districts that we serve so that we
continue to ensure a first class health service for the next 60
years."
Dr Helen Crank says: "I am delighted that NHS North Lancashire
has been able to fund this research.
Through the project I'm
working closely with Paddlers for Life, but I hope that breast cancer survivors
across the UK will be able to benefit from the results of this
work.
Dragon boat training and racing might prove to be ideal for breast
cancer survivors for a number of reasons,
not least because it
provides survivors with a vehicle for physical recovery, but being a team
activity it also
seems to help build a sense of camaraderie,
motivation for exercise, and provide a vital network of social
support amongst paddlers. By following a dragon-boat exercise training
plan, paddlers can work according
to their own fitness abilities to
improve their cardiovascular fitness and physical strength".
"Paddlers
for Life is an excellent example of how cancer survivors can improve their
physical and mental
health through exercise. Team members who
started the exercise programme with existing lymphoedema
experienced reductions in arm swelling and those members who did not
have lymphoedema did not
experience any adverse effects from this
type of exercise training. Clearly, the friendships and sense of
camaraderie that dragon boat racing fosters within the team has been
absolutely vital in giving paddlers a
sense of
wellbeing."
Paddlers for Life is a crew of cancer survivors from across
Lancashire and Cumbria, who take to Lake
Windermere each weekend in
dragon boats, go to http://www.paddlersforlife.co.uk for more
information on
Paddlers for Life.
Dragon boat racing
originated in China. Dragon boats themselves are long boats that seat between
14 and
18 paddlers together with a drummer. At the head of the boat
there is typically an ornately carved dragon
head. Races typically
involve between two and four boats over a 200 metre stretch of
water.
Source
Alexandra Bogin
Communications
Assistant
Corporate Communications Dept.
North Lancashire Teaching
PCT
Moor Lane Mills
Moor Lane
Lancaster
LA1 1QD
http://www.northlancshealth.nhs.uk
04 February
2009
-----
24 September 2009 - Ultrasound Can Predict Tumor
Burden And Survival In Melanoma Patients
Researchers have shown for the
first time that patterns of ultrasound signals can be used to identify whether
or not cancer has started to spread in melanoma patients, and to
what extent. The discovery enables doctors
to decide on how much
surgery, if any, is required and to predict the patient's probable
survival.
Dr Christiane Voit told Europe's largest cancer congress, ECCO
15 - ESMO 34 [1], in Berlin 23
September: "We have identified two
ultrasound patterns of lymph node metastasis in melanoma patients
which can identify correctly any amount of tumour cells in the sentinel
lymph nodes in 75-90% of cases
before proceeding to surgery on the
sentinel lymph nodes."
Dr Voit, who is a dermatologist and head of the
diagnostic unit at the Skin Cancer Centre at Charité -
Universitätsmedizin Berlin, the Medical University of Berlin, Germany,
said that although her research needs
to be confirmed in
multi-centre, randomised clinical trials, it had the potential to spare
patients unnecessary
surgery, especially if it was combined with
ultrasound-guided fine needle biopsy of lymph nodes rather than
conventional surgery.
Since 2001 Dr Voit and her colleagues in
Germany and The Netherlands have included 850 melanoma
patients in
a prospective study to investigate the use of ultrasound in diagnosis and
treatment planning. They
have already demonstrated that
ultrasound-guided fine needle biopsy of sentinel nodes before conventional
sentinel node surgery can identify up to 65% of patients in whom the
cancer has started to spread. The study
presented today shows how
far ultrasound patterns correlate with disease progression, tumour burden,
survival and prognosis in the first 400 of these patients with stage
I/II melanoma and with the longest follow-
up.
Before having
sentinel node surgery the patients were investigated using ultrasound, and
these results were
checked against the results of the subsequent
surgery. The researchers found that two ultrasound patterns
together could correctly identify the amount of cancer cells in the
lymph nodes in 80% of cases.
A balloon shape ultrasound pattern with or
without loss of central echoes (where the lymph node has lost
central echoes or still has some residual central echoes, but these are
wandering toward the rim, giving an
asymmetrical shape to the
centre) was an indicator in up to 83% of cases of a large amount of cancer
cells in
the sentinel node. "This ultrasound pattern was a late
sign, only occurring in cases of advanced metastasis,"
said Dr
Voit.
A pattern of peripheral perfusion (where small blood vessels start
to surround the lymph node) was an early
sign of a small number of
cancer cells present. "The early signs are signs of first disruption of the
normal
lymph node architecture by an early stage metastasis. The
most important one is peripheral perfusion, which
shows
angiogenesis (the formation of new blood vessels) is occurring," she
explained.
The researchers found that these two ultrasound patterns
could predict overall survival. Estimates for overall
survival
after five years for patients with stage I/II is between 50-90% depending on
the state of the tumour.
Dr Voit found that 93% of patients with
neither of these ultrasound patterns, 87% of patients with peripheral
perfusion,
and 56% of patients with balloon shapes with or without loss of central echoes,
survived for at
least five years; survival without cancer spreading
to other parts of the body was 74%, 60% and 26%
respectively.
Dr Voit said: "For the first time we have
established that ultrasound patterns can be used as criteria for
diagnosing disease progression and tumour burden. Balloon shaped lymph
nodes with or without loss of
central echoes and peripheral
perfusion are independent prognostic factors for survival."
Discovering
if cancer has spread to the lymph nodes is the most important factor
influencing the prognosis
and treatment of melanoma patients.
Doctors usually cut out one or two key lymph nodes, called sentinel
nodes, and use these as an indicator of whether or not the cancer has
spread to the other lymph nodes. If
the sentinel node is free of
cancer, patients don't need to have more extensive lymph node removal.
However,
only 20% of patients who have a sentinel node biopsy have cancer that has
spread there, and so
the operation, which can be accompanied by
side effects such as chronic swelling and seroma, is
unnecessary for
80% of patients. Using ultrasound first to detect the presence or not of
sentinel node
metastases could be a non-invasive way of limiting
the numbers of patients who require subsequent surgery
or simply
watchful follow-up care.
Abstract no: 9303. Melanoma session, Wednesday
14.45 -17.00 hrs CEST (Hall 7)
[1] ECCO 15 - ESMO 34 is the 15th
congress of the European CanCer Organisation and the 34th
congress
of the European Society for Medical Oncology.
Source:
Emma
Mason
ECCO-the European CanCer Organisation
1. Shire Announces FDA
Approval Of VPRIV(TM) (velaglucerase Alfa For Injection) For The Treatment
Of Type 1 Gaucher Disease - 29 May 2010
Shire plc (LSE: SHP,
Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced that
the U.S. Food and Drug Administration (FDA) has granted marketing
approval for VPRIV, a human cell
line derived enzyme replacement
therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in
pediatric and adult patients. The FDA designated VPRIV for Priority
Review and granted marketing
approval in just 6 months. VPRIV
offers patients and their physicians a new treatment option at a critical
time, as the supply of the previously approved ERT for Gaucher disease
is uncertain and remains disrupted.
"We have had the opportunity to use
VPRIV in clinical trials and actively participated in the expanded
access program. We appreciate the support Shire's management team has
provided during the last few
months to ensure continuity of care for
nearly 50 of our patients with Gaucher disease. We are confident the
team
Shire has put into place will ensure a seamless transition into the
post-regulatory period," said Gregory
M. Pastores MD, Associate
Professor of Neurology and Pediatrics at the NYU School of Medicine in New
York. "VPRIV offers patients a therapeutic option that is safe and
effective, and our experience with
VPRIV has helped build confidence
in its use, bolstered by data on low frequency of antibody
formation."
Shire recognizes that the treatments it develops for
life-altering diseases and conditions require specialized
service
and support offerings. With today's FDA approval of VPRIV, the company has
implemented
enhancements to its existing OnePath(SM) Access Program
with the introduction of a new Co-Pay
Assistance Program. The new
program was developed based on feedback from the rare disease
community. It is designed to simplify the process and paperwork
associated with initiation of therapy, and to
reduce the financial
burden for patients who are treated with Shire HGT therapies in the United
States,
including VPRIV. The Company has also announced that it will
price VPRIV at a 15% savings over the
other commercially available
ERT for Gaucher disease.
New Co-Pay Assistance Program for Eligible U.S.
Patients
The new co-pay program provides assistance for eligible
patients in the U.S. who have commercial
prescription insurance,
and helps these patients pay for out-of-pocket medication costs for Shire HGT
products, regardless of income level. Through this program, Shire
HGT intends to cover these patients'
insurance co-pay for the first
3 months of their therapy in 2010. In 2011, the Company intends to cap
eligible patients' out of pocket prescription expenses at
$500.
The new Co-Pay Assistance Program will take effect immediately,
and will apply to eligible ELAPRASE®
(idursulfase) patients and
VPRIV™ patients in the U.S.
"The last 6 months have been very
challenging for the entire Gaucher community, and the approval of
VPRIV brings an important new treatment option to patients suffering
from Type 1 Gaucher disease," said
Rhonda Buyers, CEO / Executive
Director, National Gaucher Foundation (NGF). "We at the NGF are
excited about this approval, and by the steps that Shire has taken to
improve access to treatments for
patients with life-altering
conditions. This co-pay program will greatly assist the Gaucher patient
population,
and we appreciate the fact that Shire has taken the
time to listen to us and to act on the needs of patients."
More about
VPRIV
The VPRIV application has also been granted accelerated assessment
by the European Medicines Agency
(EMA) in the European Union (EU).
Shire expects to launch VPRIV in the EU by the end of 2010 and in
other countries beginning in 2011.
Indications and
Usage
VPRIV™ (velaglucerase alfa for injection) is a hydrolytic
lysosomal glucocerebroside-specific enzyme
indicated for long-term
enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher
disease
Dosing and Administration
-- 60 Units/kg
administered every other week as a 60-minute intravenous infusion.
--
Patients currently being treated with imiglucerase for Type 1 Gaucher disease
may be switched to
VPRIV. Patients previously treated on a stable
dose of imiglucerase are recommended to begin treatment
with VPRIV
at that same dose when they switch from imiglucerase to VPRIV.
--
Physicians can make dosage adjustments on an individual patient basis based on
achievement and
maintenance of therapeutic goals. Clinical trials
have evaluated doses ranging from 15 Units/kg to 60
Units/kg every
other week.
Clinical Trial Results
Shire's VPRIV clinical trial
program included the largest and most comprehensive set of Phase III trials
conducted to date for Gaucher disease.
The efficacy of VPRIV was
assessed in three clinical studies in a total of 99 patients with type 1
Gaucher
disease. Eighty-two patients age 4 years and older received
VPRIV and 17 patients age 3 years and older
received imiglucerase.
Studies I and II were conducted in patients who were not currently receiving
Gaucher
disease-specific therapy. Study III was conducted in
patients who were receiving imiglucerase treatment
immediately
before starting VPRIV. In these studies, VPRIV was administered intravenously
over 60
minutes at doses ranging from 15 Units/kg to 60 Units/kg
every other week. Each study met its primary
endpoint.
Important Safety Information
The most serious
adverse reactions seen with VPRIV were hypersensitivity
reactions.
Infusion-related reactions were the most commonly observed
adverse reactions in patients treated with
VPRIV in clinical
studies. The most commonly observed symptoms of infusion-related reactions
were:
headache, dizziness, hypotension, hypertension, nausea,
fatigue/asthenia, and pyrexia. Generally the infusion-
related
reactions were mild and, in treatment-naive patients, onset occurred mostly
during the first 6 months
of treatment and tended to occur less
frequently with time.
Adverse reactions more commonly seen in pediatric
patients compared to those observed in adult patients
(>10%
difference) include rash, upper respiratory tract infection, prolonged
activated partial thromboplastin
time, and pyrexia.
About
Gaucher Disease
Gaucher disease is an autosomal recessive disorder
caused by mutations in the GBA gene which results in a
deficiency of
the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes
an
accumulation of glucocerebroside, primarily in macrophages. In
this lysosomal storage disorder (LSD),
clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, and other
organs. The accumulation of glucocerebrosidase in
the liver and spleen leads to organomegaly. Presence of
Gaucher
cells in the bone marrow and spleen lead to clinically significant anemia and
thrombocytopenia.
Gaucher disease is the most prevalent of the lysosomal
storage disorders diseases. Gaucher disease has
classically been
categorized into 3 clinical types. Type 1 Gaucher disease is characterized by
variability in
signs, symptoms, severity, and progression. Type 1
is the most common and is distinguished from Type 2
and Type 3 by
the lack of early neurological symptoms.
SHIRE PLC
Shire's
strategic goal is to become the leading specialty biopharmaceutical company
that focuses on meeting
the needs of the specialist physician.
Shire focuses its business on attention deficit hyperactivity disorder
(ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other
therapeutic areas to the
extent they arise through acquisitions. Shire's in-licensing, merger and
acquisition
efforts are focused on products in specialist markets
with strong intellectual property protection and global
rights.
Shire believes that a carefully selected and balanced portfolio of products
with strategically aligned
and relatively small-scale sales forces
will deliver strong results.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included
herein that are not historical facts are forward-looking statements. Such
forward-
looking statements involve a number of risks and
uncertainties and are subject to change at any time. In the
event
such risks or uncertainties materialize, the Company's results could be
materially adversely affected.
The risks and uncertainties include,
but are not limited to, risks associated with: the inherent uncertainty of
research, development, approval, reimbursement, manufacturing and
commercialization of the Company's
Specialty Pharmaceutical and
Human Genetic Therapies products, as well as the ability to secure and
integrate new products for commercialization and/or development;
government regulation of the Company's
products; the Company's
ability to manufacture its products in sufficient quantities to meet demand;
the
impact of competitive therapies on the Company's products; the
Company's ability to register, maintain and
enforce patents and
other intellectual property rights relating to its products; the Company's
ability to obtain
and maintain government and other third-party
reimbursement for its products; and other risks and
uncertainties
detailed from time to time in the Company's filings with the Securities and
Exchange
Commission.
2. Discovery Of Gene Mutation Linked To
Lymphatic Dysfunction Could Lead To First-Ever Target For
Drug
Therapy To Treat Lymphedema - 29 May 2010 -
A genetic mutation for
inherited lymphedema associated with lymphatic function has been discovered
that
could help create new treatments for the condition, say
researchers at the University of Pittsburgh Graduate
School of
Public Health. Their findings are reported in the June issue of the American
Journal of Human
Genetics.
Lymphedema, the swelling of body
tissues caused by an accumulation of fluid in a blocked or damaged
lymphatic system, affects more than 120 million people worldwide. The
most common treatments are a
combination of massage, compression
garments or bandaging.
"Lymphedema was first described hundreds of years
ago, and yet it remains a very poorly understood
disease," said
David N. Finegold, M.D., co-principal investigator of the study and professor
of human
genetics, University of Pittsburgh Graduate School of
Public Health. "Unfortunately, there is no drug
available to cure
or even treat it. Most people with inherited lymphedema suffer their entire
lives with
treatments that address symptom relief only."
The
study is based on the University of Pittsburgh Lymphedema Family Study, which
began collecting data
from affected families in 1995 to learn more
about the risk factors and causes of inherited, or primary,
lymphedema.
Previous research has helped identify six genes
linked to the development of lymphedema, but until now
researchers
had no insight into the genetic factors responsible for lymphatic vascular
abnormalities.
In their study, Dr. Finegold and colleagues sequenced
three genes expressed in families with primary
lymphedema.
Mutations in one of these genes, GJC2, was found in primary lymphedema families
and are
likely to impair the ability of cells to push fluid
throughout the lymphatic system by interrupting their signaling.
Without proper signaling, cell contraction necessary for the movement
of fluid did not occur, leading to its
accumulation in soft body
tissues.
"These results are significant because they give us insight
into the cell mechanics that may underlie this
condition," said Dr.
Finegold. "With further research, we may be able to target this gene with drugs
and
improve its function."
Study co-authors include Robert
E. Ferrell, Ph.D., Catherine J. Baty, D.V.M., Ph.D., Mark A. Kimak, M.
S.,
Jenny M. Karlsson, M.S., Elizabeth C. Lawrence, B.S., Marlise Franke-Snyder,
M.S., Stephen D.
Meriney, Ph.D., and Eleanor Feingold, Ph.D., all of
the University of Pittsburgh. The study is funded by the
National
Institutes of Health.
Source: University of Pittsburgh Schools of the
Health Sciences
-----------------------
Aklan found moderately
endemic for lymphatic filariasis - by Venus G. Villanueva - 6/4/10
Kalibo,
Aklan (4 June) -- The province of Aklan has been declared as moderately endemic
for Lymphatic
Filariasis, with a Microfilaria Rate of 6.2%,
according to Governor Carlito S. Marquez.
With this rate, Governor Marquez
said Aklan is a candidate for Mass Drug Immunization (MDA). World
Health Organization (WHO) guidelines state that a Microfilaria Rate of
1% and above requires a province to
avail of the MDA.
Lymphatic
Filariasis (LF) is a parasitic disease caused by microscopic, thread-like worms
that live in the
human lymph system, according to the Department of
Health (DOH).
The DOH further revealed that LF is a disease of the poor
which may be acquired during childhood.
Parasites live in the
lymphatics for 5-15 years.
A person gets filariasis through bites of
infected female mosquito. The Aedes poecilus,, primary vector, lives
in
the leaf axils of abaca, banana, pandanus, pakil, gabi and other axilled
plants. It is a primary nocturnal
feeder but can be "diurnal"
inside abaca plantations under low temperature and high humidity.
The
mosquito's peak biting time is between 10 p.m. to 12 midnight. It rests indoors
inside houses briefly
after biting; and rests outdoors on the bases
of trunks of abaca and other axilled plants.
In its chronic stage,
filariasis develops 5-15 years after the death of adult filarial parasites.
Effects of filariasis
include hydrocoele, lymphedema, elephantiasis
and chyluria.
Elephantiasis is evident with the swelling of lower
extremities, scrotum in males (hydrocoele) upper
extremities, and
breasts. The disease is usually not life threatening, but it can permanently
damage the lymph
system and kidneys. Because the lymph system does
not work,right, fluid collects and causes swelling in the
arms,
breasts and legs.
In Aklan, municipalities with filariasis cases are Libacao
and Madalag, the province's major producer of
abaca.
Marissa
Carillo, PHO-Aklan's point person on filariasis, revealed that of Libacao's 500
residents tested for
infection, 46 were found positive through their
blood samples, while Madalag had 15 out of 500 samples.
Carillo said the
treatment, which will be given for free to all Aklan residents aging 2 years
and above, will be
provided in time with the observation of
Garantisadong Pambata (GP) October of this year.
To prepare Aklanons and
health workers for the conduct of the MDA, the provincial government through
the PHO, in partnership with the DOH, has set meetings and
trainings for stakeholders and health workers,
most of which will be
held this month of June. (PIA)
WNC wellness review - by Wade Inganamort
on 06/05/2010
Tai Chi Offers Special Benefits for Cancer Survivors - "The
emphasis on relaxed breathing and gentle
moves enhances the
lymphatic system, adding to the benefits for women at risk of lymphedema
following
surgery."
New cancer guidelines: Exercise during
and after treatment is now encouraged - June 1, 2010
Cancer patients who've
been told to rest and avoid exercise can - and should - find ways to be
physically
active both during and after treatment, according to new
national guidelines. Kathryn Schmitz, PhD, MPH,
an associate
professor of Epidemiology and Biostatistics and a member of the Abramson Cancer
Center at
the University of Pennsylvania School of Medicine, will
present these guidelines at an educational session at
the 2010
meeting of the American Society of Clinical Oncology, aimed at making cancer
exercise
rehabilitation programs as common as those offered to
people who have had heart attacks or undergone
cardiac surgery.
(Exercise Testing and Prescription for Cancer Survivors: Guidelines from the
American
College of Sports Medicine)
Cancer: Natural Clinic
- Best cancer clinic. Best results. Naturopathic Medical Doctors (NMD) -
www.
NatureWorksBest.com
Schmitz, whose previous research
reversed decades of cautionary exercise advice given to breast cancer
patients
with the painful arm-swelling condition lymphedema, led a 13-member American
College of Sports
Medicine expert panel that developed the new
recommendations after reviewing and evaluating literature on
the
safety and efficacy of exercise training during and after cancer
therapy.
"We have to get doctors past the ideas that exercise is harmful
to their cancer patients. There is a still a
prevailing attitude
out there that patients shouldn't push themselves during treatment, but our
message --
avoid inactivity - is essential," Schmitz says. "We now
have a compelling body of high quality evidence that
exercise
during and after treatment is safe and beneficial for these patients, even
those undergoing complex
procedures such as stem cell transplants.
If physicians want to avoid doing harm, they need to incorporate
these guidelines into their clinical practice in a systematic
way."
Cancer patients and survivors should strive to get the same 150
minutes per week of moderate-intensity
aerobic exercise that is
recommended for the general public, the panel says. Though the evidence
indicates
that most types of physical activity - from swimming to
yoga to strength training -- are beneficial for cancer
patients,
clinicians should tailor exercise recommendations to individual patients,
taking into account their
general fitness level, specific diagnosis
and factors about their disease that might influence exercise safety.
Cancer
patients with weakened ability to fight infection, for instance, may be advised
to avoid exercise in
public gyms.
One persistent area of
concern for cancer patients is change in body mass -- both weight gain and
weight
loss tied to disease symptoms and treatment side effects.
Patients with hormone-based tumors, breast and
prostate cancers,
tend to gain weight during treatment and frequently have difficulty losing it.
Other patients,
especially those with gastrointestinal tumors,
suffer from weight loss brought on by loss of appetite and
changes
in their ability to swallow and properly digest food. The new guidelines
indicate that both groups
can benefit from exercise. Studies show,
for instance, that exercise for weight control and reduction in body
mass may actually reduce the risk of recurrence for breast cancer
patients, and ultimately decrease breast
cancer mortality. For
patients suffering from cancer-related weight loss, physical activity helps to
maintain
lean body mass, which can contribute to increased strength
and well being.
Cancer: Natural Clinic - Best cancer clinic. Best
results. Naturopathic Medical Doctors (NMD) - www.
NatureWorksBest.com
Schmitz and her colleagues analyzed published
studies related to five different adult cancer types (breast,
during and after treatment, prostate, hematologic -- with and without
stem cell transplant -- colon, and
gynecologic), and reviewed the
evidence for multiple health outcomes. The panel found that although there
are specific risks associated with cancer treatment that need to be
considered when patients exercise, there
is consistent evidence
that exercise training can lead to improvements in aerobic fitness, muscular
strength,
quality of life and fatigue in breast, prostate, and
hematologic cancer patients and survivors. They found the
data for
colon and gynecologic cancers were too scant to draw firm conclusions, and
identified several areas
requiring further study. Age, for instance,
is a critical variable, Schmitz says, since more must be learned
about the effects of physical activity in cancer patients over age 65,
to develop interventions that may help
these patients continue to
live and function independently.
The panel urges fitness professionals
to enhance their capacity to serve the unique needs of cancer survivors.
Schmitz noted that a "groundswell" of training programs now assist
physical therapists and fitness trainers in
deepening their
knowledge of the effects of cancer diagnosis and treatment and improve their
skills in this
emerging area.
Schmitz also feels strongly
that practicing oncologists need to be informed about the new guidelines and
their
importance, and says that patients can play a role in
changing attitudes and clinical practice. Her hope is that
patients
will read the recommendations and discuss them with their doctors, creating the
demand for change
that will drive more cancer centers and oncology
practices to create and offer cancer exercise rehabilitation
services.
Schmitz will present the new guidelines at an
educational session on Sunday, June 6, from 4:45 to 6:00
p.m.
Provided by University of Pennsylvania School of
Medicine
Health Briefs - Compiled by Suzanne Wilson - June 04,
2010
LYMPHEDEMA - A monthly education and support group for those with
lymphedema meets at Cancer
Connection, in the Silk Mill building on
the corner of Straw Avenue and Locust Street in Florence.
Registration required. Contact Kathryn at 584-4076.
Man's simple
wish remains unfulfilled - By MARY WESTON - 06/07/2010
THERMALITO -- As the
weather warms up, Ernie Foss' simple wish becomes more fervent.
He would
like to go outside.
For the last two years in Hayward and now in Thermalito,
Foss has been a prisoner in his home.
"I would like to be able to go out in
my yard and help my wife with household chores like taking out the
trash," Foss said. "I would like to have people over for a barbecue and
actually barbecue the food myself."
Foss also needs to get out of the house
to go to the doctor at the Oroville Family Health Center. After the
first visit, he could have home visits from a nurse.
Recently, with
donated building materials from Home Depot, labor from the Father's House
Church and
plans and permits from retired deputy Bill Sumner, a
wooden ramp was built at Foss's front door.
Foss's dream to get outside
almost came true.
However, they found he also needs concrete for a pad at
the base of the ramp and ideally the front doorway
widened to allow
access for his electric wheelchair.
Foss has secondary lymphedema that
causes both his thighs to swell to probably more than 75 inches
around.
"Lymphedema occurs when your lymph vessels are unable to
adequately drain lymph fluid, usually from an
arm or leg,"
according to www.mayoclinic.com.
For Foss, this means fluid accumulates in
his legs, causing his lower body to swell massively.
The disease can occur
on its own, or it can be caused by another disease or condition that damages
the
lymph nodes or lymph vessels, s happened to Foss.
Doctors
think Foss's condition was caused either by a surgery or an infection that
damaged the lymphatic
system in his legs.
Before acquiring the
disease, Foss was active, his wife, Linda said. Exercising and lifting weights,
he
maintained about 200 pounds on his six-foot frame.
He rode
with others on long bike rides in the Bay Area, surfed and enjoyed outdoor
activities.
He also had a job he loved. He has two degrees in computer
science and computer networking.
But he had to retire from Heald's College
as learning resource center manager about two years ago when his
condition worsened.
After a long hospital stay, he and his wife
couldn't pay the rent on their house in Hayward.
Linda Foss was also
disabled from an injury she sustained while working as an animal keeper at a
zoo.
They finally found a house in Thermalito and moved here last
November.
He was brought in a medical transit vehicle, and Cal Fire-Butte
County firefighters carried him into the house.
Foss has an electric
wheelchair, but it's too wide to go inside the front door.
Foss would like
to ride the wheelchair that is all-wheel-drive around in the about quarter-acre
yard. He
would also like to be able to take the cart and ride in a
transit to attend some events in Oroville.
Foss, who plays seven musical
instruments, also likes the idea of being able to get outside to entertain and
cook for friends.
And he would like to be active and known in the
community, he said.
"I still have a lot going on up here," Foss said,
pointing to his head. "And I have a strong heart and spirit."
Foss, who
loves to cook, would also like to have his electric wheelchair in the house so
he could cook
meals for his wife, who goes to dialysis three times
a week and still keeps the house immaculate.
The Fosses are both amiable
people who laugh and find humor in simple things like the donkey next door
who walks in circles so much it has worn an oval track on the
property.
And there's the "bushaloes" they discovered on the hill across the
pasture. He thought they were buffaloes,
until she asked him if he
didn't think it was strange that they never moved.
She drove out on the hill
and found they were bushes somewhat shaped like buffaloes. She called him on
the
cell phone and he saw her waving from the hill across the
way.
"Honey, they're bushaloes," she said from the phone.
When they
argue, rather than talking, they e-mail each other from their computers while
sitting in the same
room.
"It's not an easy life, but we make the
best of it," Foss said. "What else can we do?"
Lymphedema education is
crucial says physical therapist and member of Saskatchewan Lymphovenous
Learning Association (SLLA) - By PAMELA ROTH - May 25, 2010 REGINA —
Glenda Cook had a lot
to fear when she was diagnosed with breast
cancer two years ago.
She knew it would be a tough battle to reclaim her
health, but when she found out she was at a high risk for
developing lymphedema —a chronic condition that causes a visible
build-up of fluid in the arm — the 54-
year-old began to fear the
worst.
"I had more fear of lymphedema than breast cancer just because it's
with you forever," said Cook. "It was
very hard, but you try and
stay positive and think it won't happen to you."
Shortly after her surgery,
Cook's fear came true when she noticed her arm was tingling and felt heavy. It
was
also beginning to swell.
For Cook, the official diagnosis
was devastating.
Once a member of the Regina Symphony Orchestra, she can no
longer play the violin — a passion of hers
for nearly 40
years.
Simple tasks, such as cleaning the house and gardening, have also
became a challenge.
Now, much of Cook's daily routine centres around
managing her chronic condition, which involves draining
the fluid
from her arm and wearing compression garments.
"You have to do everything
slowly or your arm will start to swell," said Cook. "It's a constant reminder
that
you had breast cancer and you can't just forget
it."
Lymphedema is a condition that affects many people, but cancer
survivors are often at a higher risk for
developing the
condition.
Normally, lymph fluid, which keeps tissues free of infection, is
filtered through lymph nodes (glands) in the
armpit on its way to
the blood stream. But during breast cancer treatment, the lymph nodes in the
armpit are
often taken out by surgery to see if the cancer has
spread.
When this happens, the lymph fluid can no longer leave the arm
through its normal channels in the armpit,
thus causing a continual
build-up of fluid.
Tracy Gardikiotis, a physical therapist at the Pasqua
Hospital, specializes in breast cancer rehabilitation for
lymphedema
and usually treats about a dozen patients with a range of symptoms each
day.
According to Gardikiotis, if the condition is caught relatively early,
it can be minimized and kept under
control.
Most women who
develop arm lymphedema do so within four years of their breast cancer
treatment, but it
can also appear several years after
surgery.
Gardikiotis said education about the condition is crucial, which is
why she's a member of the Saskatchewan
Lymphovenous Learning
Association (SLLA), a non-profit organization that educates and supports
patients,
health professionals and the public on
lymphedema.
Since the condition isn't well known in Saskatchewan,
Gardikiotis said it's often misdiagnosed, poorly
treated, and not
covered under health insurance.
With the proper treatment, however,
Gardikiotis has watched many people suffering from the condition take
back
their life, including Cook.
"It's life-long, so once they develop it, it's a
matter of dealing with it," said Gardikiotis. "It can cause some
pretty significant psychological and social impacts on their
life."
On May 30, SLLA will be hosting its first fundraiser and awareness
event in Regina — a pancake breakfast
at the Copper Kettle from 9
a.m. to 12 p.m.
Alexandria and Arlington health calendar - June 10, 2010
- Friday 11LYMPHEDEMA AWARENESS
LECTURE, specialists discuss
lymphedema caused by cancer treatment. 11 a.m.-noon, Virginia Hospital
Center, Cancer Resource Center, 1701 N. George Mason Dr., Arlington.
Free, registration required. 703-
558-0908. When swelling gets out
of hand Post-surgery lymphedema often goes untreated - by Grania
Litwin - June 10, 2010
Lymphedema is a physical and
emotional problem for many post-surgery cancer patients, "and all too often
not diagnosed," says Canadian lymphedema expert Dr. Anna
Towers.
"People go to emergency with a skin infection or ulcer and they are
treated for that, but not for the
underlying cause, which is severe
swelling [lymphedema]," says the McGill University professor.
She visited
Victoria recently to talk about lymphedema, a fluid-retention condition that
can affect anyone
who has had radiation or surgery involving lymph
nodes.
Towers is founding chairwoman of the newly formed Canadian Lymphedema
Framework, which seeks to
raise the profile and treatment of this
condition.
Lymph is a fluid, found between the body's cells, that is carried
by the lymphatic system through nodes.
Unlike blood, it has no
central pump, but moves due to muscle action. Under ideal conditions, the fluid
feeds
cells and carries away excess waste and cancer cells, says the
palliative care physician.
But when damaged, the system doesn't drain well
and any inflammation causes even more to build up.
"We're doing a large
Canadian study now following women who've had breast cancer. We're only halfway
through; the study goes from 2005 to 2015, and already we're showing
17 per cent have lymphedema.
"It can appear immediately after treatment or
years later, after an injury -- a suntan, an infection from an
insect sting, even air travel," Towers says. "Inflammation exacerbates
the problem."
Untreated, lymphedema can lead to disability, loss of
function, job loss and early death.
Forty per cent of patients with the
condition develop complications ranging from infection to blood clots,
says Towers, associate professor in McGill's oncology department and
former director of its palliative care
division. She is advocating
across the country for better research, care and medical coverage.
About
25,000 new cases occur in B.C. every year, mostly following surgeries for
breast, prostate,
colorectal, gynecological or melanoma cancers.
(The condition can also be genetic.)
Once lymphedema develops, the preferred
treatment is hands-on, decongestive massage to softly guide
lymph
in the right direction, to reduce swelling and improve function. A compression
garment or bandage is
worn for maintenance.
Robert Harris
operates the Dr. Vodder clinic here, which trains therapists in the massage.
"It's very light,
gentle, rhythmic, and stimulates the lymph
vessels to pump," he says. "Patients love it," and frequent massage
can bring a limb down 40 to 50 per cent in a month, which also lowers
infection risk.
"The therapy is life-changing but its success depends on how
soon it happens." One hour costs about $85.
The medical services
plan picks up $23, while some extended-health plans pay more.
A 60-year-old
woman, who asked not to be identified, had a recent lumpectomy and developed
swelling in
her hand, arm and breast. "It was like an overfilled
balloon. I couldn't close my fist, get my rings off. But
after about
six treatments the therapist got my breast draining and my hand working.
"I
tried to get physio at the cancer clinic, but was told it would be up to six
week. I didn't want to wait
because it was getting bigger and
bigger. This therapy is wonderful."
Combined decongestive therapist Beth
Atkinson took the Dr. Vodder lymph drainage course and works at
Vitality Treatment Centre in Oak Bay, with others trained in the
specialty. There are eight in the city.
"We cover seven days a week, because
when a person comes in with a severe problem, there's an intense
phase before maintenance can begin. We might see them three, four times
a week, for three weeks.
"A patient might have a leg that weighs twice
what's normal. Even after massage, there's tremendous
difference.
People get off the table and say: 'Wow, I can bend my knee.' [Excess water is
eliminated through
waste.]"
She adds lymph drainage is useful for
other inflammatory conditions, too, and patients can learn to do it
themselves.
Towers says the therapy should be covered by provincial
medical plans, but blamed lack of leadership.
Health policy favours
prevention and treatment -- "as it should" -- but that leaves less for followup
care, she
says.
Because the treatment is not pharmacological,
"we don't have the benefit of pharmaceutical firms' resources
to
help advocate." In addition, many problems appear years after the cancer
management ends.
The B.C. Cancer Agency recommends patients contact the Dr.
Vodder school -- www.vodderschool.com
or at 250-598-9862 for
combined decongestive therapy. It's not available in hospitals, which use
compression pumps instead.
------------------------------------------
ymphatic System: Regulator of Lymph Vessel Growth Uncovered - Science Daily
(press release) -
Thursday, April 1, 2010
ScienceDaily (Apr. 3,
2010) — In addition to our network of blood vessels, humans have a network
of vessels known as lymphatic vessels. These vessels have a role in many
processes in the body,
including regulating fluid levels in tissues
and immune surveillance.
Although dysfunction in the lymphatic system
contributes to human diseases such as the spread of
cancer to other
sites and lymphademas (localized fluid retention and tissue swelling), little
is known
about the molecules that regulate the formation of new
lymphatic vessels, a process known as
lymphangiogenesis.
However, a team of researchers, led by Sophia
Tsai and Ming-Jer Tsai, at Baylor College of Medicine,
Houston, has
now identified a role for the gene regulatory protein COUP-TFII in
lymphangiogenesis in
mouse embryonic development and tumor
lymphangiogenesis in adult mice.
The authors therefore suggest that
COUP-TFII might be an effective molecular target in pro-
lymphangiogenic treatment of lymphedemas or in antilymphangiogenic
therapy targeting tumor
spreading via the lymphatic
vessels.
The research appears in the Journal of Clinical
Investigation
---------------------------------------------------
Alt.Health
What
the nodes know
Lymphatic drainage unplugs fluid flow and eases acne
By
Elizabeth Bromstein
“Ooh, half-price lymphatic drainage massage!” My friend
said, checking an email offer from a spa.
“Wow,” I said. Then, “Wait
a sec – what exactly does that do?”
“I don’t know. Drains your lymphs?”
Sounded about right.
Your lymphatic system is a network of organs, lymph
nodes, lymph ducts and lymph vessels that
carries a clear fluid
called lymph.
Lymphatic massage, it turns out, is touted for everything
from cellulite treatment to post-cancer care
and everything – and I
mean everything – in between.
One thing it definitely works for is the
treatment of lymphedema, fluid retention and swelling caused by
a
compromised lymphatic system. This can be hereditary or (there are many
possible causes) the result
of injury to the lymphatic vessels,
lymph node dissection, surgery or radiation therapy.
People with
lymphedema should be vigilant about where they go for treatment, as I’m told
“certification” can be achieved in a weekend. I’m guessing that if
the place also offers facials and
eyebrow threading, you want to
check the credentials.
Its other uses are the subject of some
discussion.
What the experts say
“Any time we bring nutrients to our
cells or clear away their waste, the lymphatic system is involved. It’
s
part of our immune response. I work when the system has been disrupted, which
can result in
swelling, failure to heal or lack of movement in a
joint. I deal with post-cancer patients, especially
breast. The
massage is good for injuries or sinus trouble, any kind of congestion in the
tissue. The
consumer has to ask the practitioner: ‘How many hours of
post-grad training do you have?’ If it’s post-
cancer treatment, the
right answer is 135 hours. For a strain, it’s 80.”
JANET McFARLAND,
physiotherapist, Toronto
“We have a ‘lymphomaniac facial’ that
incorporates massage into a facial. It’s not just for aesthetics,
but for total body health. When you’re prone to water retention and
puffiness, that’s an accumulation of
excess lymphatic fluid. We
follow the Ayurvedic view that lymphatic stagnation leads to other
accumulation and dysfunction of the body. We also do breast massage.
There is a lot of stagnation in
that area because we don’t touch it
a lot. The main site of lymph is in the underarm, so we do that,
too.”
KRISTEN MA, author, Beauty: Pure + Simple,
Toronto
“Lymphatic drainage is effective when the lymphatic system is
not responding physiologically. The
studies have not been done on
healthy people, but I would suspect that the same intervention will not
increase lymphatic flow beyond what the body requires. The system
auto-regulates and is very efficient
when not diseased. Cellulite
is not fluid. It’s stored fat. No amount of stimulation is going to change
that. I understand that this treatment is offered in ‘health spas’ for
otherwise healthy individuals, but it’s
unlikely that somebody who
went through the 180 hours of additional training to get this certification
would use it to treat healthy people.”
STANLEY ROCKSON, Lymphatic
Research Foundation advisory board, Stanford, California
“We use the
Vodder method of manual lymph drainage (MLD). We lightly manoeuvre the skin to
motivate the fluid to move toward the nearest lymph nodes. Normally,
the system does this by itself, but
we help increase the speed of
drainage. In a medical setting, the method is used for lymphedema
management, venous congestion, burn patients, ulceration. It’s also used
for sprains and strains,
fractures or chronic pain, as with
fibromyalgia, migraines, whiplash or tension headaches. It can be
helpful for acne, rosacea, eczema.”
ROBERT HARRIS, director, Dr.
Vodder School, Victoria, BC
“Lymphatic drainage is helpful for edema as
well as skin issues like scars and acne. When we have
acne, the
hair follicles are filled with oil and bacteria. A lymphatic massage decreases
pain and swelling.
There are contraindications. These are malignant
disease, acute inflammation with infection – because
you can spread
that around – and acute allergic reactions. It’s very relaxing, because it’s
totally
different from Swedish or deep tissue massage. It’s very
gentle.”
THERESA CROLLY, registered massage therapist, Toronto
http://www.nowtoronto.com/lifestyle/story.cfm?content=174399
-----------
A Century-Old
Puzzle Comes Together, Scientists ID Potential Protein Trigger In Lung Disease
Sarcoidosis - 04 May 2010
Lung researchers at Johns Hopkins
have identified a possible protein trigger responsible for
sarcoidosis, a potentially fatal inflammatory disease marked by tiny
clumps of inflammatory cells that
each year leave deep, grainy
scars on the lungs, lymph nodes, skin and almost all major organs in
hundreds
of thousands of Americans.
The disorder, whose cause has been a
persistent mystery for nearly a century, strikes mostly young
adults and disproportionately affects African Americans.
The
link between sarcoidosis and overproduction of the suspected protein trigger,
called serum amyloid
A, was revealed after a six-year investigation
encompassing more than two dozen laboratory
experiments, including
some on diseased lung tissue samples from 86 patients in the Baltimore
area.
"The increase in production of serum amyloid A explains for the
first time how inflammation can persist
in the lungs without being
triggered by an active infection," says study senior investigator and
pulmonologist
David Moller, M.D., a professor at the Johns Hopkins University School of
Medicine.
Moller is also director of the sarcoidosis clinic at The
Johns Hopkins Hospital.
Study lead investigator Edward Chen, M.D., says
the new findings also clear the path for developing
drug treatments
or vaccines that can block serum amyloid A from binding to cell receptors and
kicking
off inflammation.
In the short term, however, Moller
says his team has plans to use the study results to create diagnostic
tests
that could better predict which people with the disease are likely to heal on
their own or are more
likely to suffer persistent inflammation,
which can lead to scarring, difficulty breathing, and heart failure
that can only be fixed by lung transplantation.
In a report
published in February in the American Journal of Respiratory and Critical Care
Medicine,
the Johns Hopkins scientists described their research on
what was behind the microscopic clusters of
inflamed tissue and
white blood cells, or granulomas, which are a defining feature of
sarcoidosis.
Such lung lesions are not unique to sarcoidosis and can be
triggered by infections, such as in
tuberculosis, which is often
confused with sarcoidosis. But unlike tuberculosis, sarcoidosis is not an
infectious disease, does not yield to antibiotics, and is not limited
to any particular organ, occurring as
well in the eyes, skin, brain,
heart and liver.
Of particular interest to researchers was the role
played by so-called amyloids, a set of proteins known
to cause
other persistent inflammatory conditions, such as amyloidosis. Indeed, a
different kind of
amyloid has been tied to plaques in the brain
tissue of people with Alzheimer's disease.
Key among the researchers'
findings in sarcoidosis patients was that serum amyloid A stood out
because it was heavily concentrated within the granulomas in diseased
and scarred lung tissue.
Researchers found the protein a hundred to
a thousand times more widespread in sarcoidosis tissue
samples than
in samples from people with tuberculosis, another granuloma-forming lung
disease.
Similarly elevated amyloid levels were seen in comparison
tests with tissue samples from people with
lung cancer and Crohn's
disease.
Further tests in patients' lung cell cultures showed that
adding serum amyloid A spiked production of at
least a half-dozen
key inflammatory chemicals known to be involved in damaging tissue.
In
another series of experiments in mice, the team discovered that granuloma
formation in the lungs
sped up when the mice were given injections
of synthetic serum amyloid A. Mice had previously been
injected with
specially coated plastic beads designed to trigger sarcoidosis-like lesions.
Adding the
synthetic protein led to the same biochemical reactions
in the mice as observed in humans, suggesting to
the researchers
that serum amyloid A played a key role in triggering sarcoidosis.
To
better understand how serum amyloid A might be driving granuloma formation, the
team used
special antibodies to block various cell surface receptor
sites where the protein would bind to the white
blood cells and spur
inflammation. Tests in human lung cells showed that blocking one particular
receptor, toll-like receptor-2 (TLR2), inhibited the sustained
inflammatory reaction typically associated
with sarcoidosis. But
when left to bind on its own, without an antibody blocking TLR2, the open
receptor could attach to serum amyloid A, and raised production of
inflammatory chemicals would
ensue.
"Not only have we shown
that serum amyloid A is a key protein trigger in sarcoidosis, but we also have
evidence that the resulting inflammation is dependent on binding
the protein at toll-like receptor-2,
which opens up a host of
possibilities that drugs blocking this binding site could prove an effective
treatment for this disease," says Chen, an assistant professor at
Johns Hopkins.
Funding support for the report and research was provided
by the National Institutes of Health, the
American Thoracic
Society, the Foundation for Sarcoidosis Research, the Life and Breath
Foundation,
and the Hospital for the Consumptives of Maryland
(Eudowood.)
In addition to Moller and Chen, other Johns Hopkins
researchers involved in this study were Zhimin
Song, M.D.; Matthew
Willett, B.S.; Shannon Heine, B.S.; Rex Yung, M.D.; Mark Liu, M.D.; Steve
Groshong, M.D., Ph.D.; Ying Zhang, M.D., Ph.D.; and Rubin Tuder,
M.D.
Source: Johns Hopkins Medicine
------------
June
25, 2010 - Decongestive Physiotherapy Helps Patients With Painful Leg Swelling
–
For patients with painful swelling of the legs caused by
chronic venous insufficiency (CVI), a
combination treatment
approach called "complete decongestive physiotherapy" improves symptoms,
walking ability, and quality of life, reports a study in Topics in
Geriatric Rehabilitation. The journal is
published by Lippincott
Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of
information and business intelligence for students, professionals,
and institutions in medicine, nursing,
allied health, and
pharmacy.
Complete (or "complex") decongestive physiotherapy (CDP) can
greatly reduce leg swelling and pain
in patients with CVI, according
to the new study, led by Yesim Bakar, Ph.D., P.T., of Abant Izzet
Baysal University in Bolu, Turkey. Another paper in the same issue of
TGR shows similar benefits of
CDP in a patient with lymphatic
obstruction (lymphedema) related to the skin condition
psoriasis.
Complete Decongestive Physiotherapy Brings Good
Results
Dr Bakar and coauthors evaluated the effects of CDP in 62 older
adults (average age 65 years) with
CVI. Patients with CVI have poor
blood flow in the veins of the leg, leading to fluid buildup. This
results in painful swelling, making it difficult for patients to walk
and perform other activities. Usually
only one leg is
affected.
All patients were treated using the CDP approach, which
combines four types of physical therapy
treatments:
--
Manual lymph drainage massage to promote drainage of the lymph nodes.
--
Skin care moisturizers and other treatments for skin changes caused by poor
circulation.
-- Compression bandages are applied to prevent fluid from
reaccumulating.
-- Exercise simple leg exercises to improve blood flow
and leg motion.
For the first month, patients met with a physical
therapist five days a week for treatment. They also
received
education in performing each of the four types of therapy for themselves. The
goal was to
keep fluid buildup under control through lifelong,
daily self-care.
The CDP treatment program dramatically reduced leg
swelling on average, fluid buildup in the affected
leg decreased by
the equivalent of nearly half a liter. Pain was also decreased, from an average
score of
67 to 18 on a 100-point scale. Patients had improved
walking ability, less pain when walking, and
improved ability to
perform daily activities. The authors believe that including exercise in the
treatment
program was a key factor in improving walking
ability.
Dr. Bakar is also a co-author of the other paper, which reports
on the use of CDP in a woman with
lymphedema related to the chronic
skin condition psoriasis. In patients with lymphedema, obstruction of
the
lymph nodes causes similar symptoms of leg pain and swelling. In both the short
and long term,
CDP brought significant improvement in pain,
swelling, and activity.
Inconclusive Results From Research Into
Biologics-Associated Cancer Risk - 18 June 2010
Biologics-naive
Juvenile Idiopathic Arthritis (JIA) patients may have an increased risk of
cancer
compared with the general Swedish population, according to
research presented at EULAR 2010, the
Annual Congress of the
European League Against Rheumatism in Rome, Italy. Results of an additional
study, which researched a small cohort of patients showed an increased
frequency of cancer in those
receiving the biologic etanercept,
however, results were deemed not statistically significant by
researchers.
The results of a population-based Swedish cohort
study found that the incidence of cancer among
paediatric patients
with JIA identified during the last 40 years was comparable to that seen in the
general population, (0.5 vs. 0.4 cases per 1000 person years,
Relative Risk (RR)=1.1, 95%CI 0.9-
1.5). Subset analyses however
indicated that subjects diagnosed with JIA since 1987 (the year that the
Swedish patient registry attained nationwide coverage) were at elevated
risk of developing cancer
(RR=2.3, 95%CI 1.2-4.4, 13 JIA cancers
vs. 30 in comparator), attributed to an increased
occurrence of
cancers of the lymphatic system (RR=4.2, 95%CI 1.7-10.7, 8 cancers in JIA vs.
10 in
comparator).
"These results are intriguing and suggest
that in the past 20 years, patients with JIA not treated with
biological therapies appear to have an elevated risk of cancer compared
with the general population,"
said lead author of the study Dr.
Julia Simard, Clinical Epidemiology Unit, Karolinska Institute,
Stockholm, Sweden. "The results of our study indicate that evaluation
of cancer risks with biologics in
paediatric populations need to
factor in differences in incidence of cancer between these patients and
the general population. From a clinical point of view, it should be
remembered that although we noted
an increased risk in relative
terms, the excess risks remain low in absolute terms."
The Swedish study
assessed a national JIA cohort of 9,020 patients. For each JIA patient, up to
five
general-population comparators were identified (n=44,858). In
the biologics-naïve JIA cohort, 60
cancers were observed during
131,144 person-years compared to 266 cancers during 661,758
person-years in the population comparator. Researchers noted that
sensitivity analyses did not reveal
an explanation for the
differences seen between patients identified before and after 1987.
The
results of the second study combined data on 1,721 patients treated with
etanercept from three
prospective JIA registries in Germany, the UK
and the US. Of the 1,641 patients who qualified for the
primary
analysis, two cancers were reported. Whilst this yielded a rate higher than
expected when
compared to the general population, it was not
statistically significant (RR estimated using a
Standardized
Incident Ratio (SIR) of 3.7 (0.5-13.4, 95%CI)). This is believed to be in part
due to the
low event rate. The interpretation of these findings may
be further limited by the fact that the
comparator rates were based
on a general population and not a biologics-naïve JIA population, as per
the Swedish study, which suggests this may indicate an increased
underlying risk of cancer.
Abstract Numbers: OP0086 &
OP0274
Source:
Caroline Butt
European League Against
Rheumatism
July 14, 2010 - Protalix BioTherapeutics Receives PDUFA
Date For Taliglucerase Alfa -
Protalix BioTherapeutics, Inc.
(NYSE-Amex: PLX), announced that the Company's New Drug
Application
(NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and
Drug
Administration (FDA). The FDA granted taliglucerase alfa a
standard review time of ten months,
assigning a Prescription Drug
User Fee Act (PDUFA) action date of February 25, 2011. Taliglucerase
alfa
is the Company's proprietary plant cell expressed recombinant form of human
Glucocerebrosidase
(GCD) which is being developed for the treatment
of Gaucher disease under a Special Protocol
Assessment (SPA) with
the FDA. Following the completion of a phase III clinical trial of
taliglucerase
alfa, the Company completed the submission of a
rolling NDA with the FDA in April 2010.
"If approved, taliglucerase alfa
will be an attractive and important therapeutic option for Gaucher
patients," said Dr. David Aviezer, President and Chief Executive
Officer of Protalix. "We look forward
to working closely with the
agency through this final stage of the review process."
Taliglucerase
alfa has been granted orphan drug designation from the FDA in the United
States. The
Company continues to make taliglucerase alfa available
to Gaucher patients in the United States under
an Expanded Access
protocol, as well as to patients in the European Union, Israel and other
countries
under Named Patient provisions.
About Gaucher
disease
Gaucher disease, an inherited condition, is the most prevalent
lysosomal storage disorder, with an
incidence of about 1 in 20,000
live births. People with Gaucher disease do not have enough of an
enzyme, beta-glucosidase (glucocerebrosidase), that breaks down a
certain type of fat molecule. As a
result, lipid engorged cells
(called Gaucher cells) amass in different parts of the body, primarily the
spleen, liver and bone marrow. Accumulation of Gaucher cells may cause
spleen and liver enlargement,
anemia, excessive bleeding and
bruising, bone disease and a number of other signs and symptoms.
About
Protalix
Protalix is a biopharmaceutical company focused on the
development and commercialization of
proprietary recombinant
therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalix's ProCellEx™ presents a proprietary method
for the expression of
recombinant proteins that Protalix believes
will allow for the cost-effective, industrial-scale production
of
recombinant therapeutic proteins in an environment free of mammalian components
and viruses.
Protalix is also advancing additional recombinant
biopharmaceutical drug development programs.
Taliglucerase alfa is
an enzyme replacement therapy in development under a Special Protocol
Assessment
with the FDA for Gaucher disease. Protalix filed a rolling NDA submission with
the FDA
in December 2009. In November 2009, Protalix granted Pfizer
Inc. exclusive, worldwide rights to
develop and commercialize
taliglucerase alfa for the treatment of Gaucher disease, except in Israel.
Protalix retained the right to commercialize taliglucerase alfa in
Israel.
August 5, 2010 - Ease The Aftermath Of Breast Cancer With
New Imaging Technique -
A new study of breast cancer survivors
may help physicians ease a common side effect of cancer
treatments.
The collaborative research by Eva Sevick, Ph.D., Director of the Center for
Molecular
Imaging at the University of Texas Health Science Center
in Houston (UTHSC), and Caroline Fife, M.
D., Director of the
Memorial Herman Wound Care Clinic at UTHSC, could bring relief to
millions.
Their paper appears in the inaugural issue of Biomedical
Optics Express, an online, open-access
journal published by the
Optical Society (OSA). The papers featured in the journal will encompass
theoretical modeling and simulations, technology development,
biomedical studies and clinical
applications.
A substantial
number of breast cancer survivors suffer from lymphedema in the aftermath of
their cancer
surgeries. In lymphedema, fluids accumulate in the
arms, potentially causing disfiguring and debilitating
swelling
that can impact quality of life.
Treatments vary, but they generally
consist of using manual and pneumatic therapies to "push" or
stimulate the body to remove excess fluid and reduce tissue swelling.
Finding out whether a treatment is
working can take months. That's
because the current method of assessing progress is to measure the
circumference or volume of a limb and check for changes in swelling -
and a size change big enough to
be measured takes
time.
During this time, the condition might improve - or it might
worsen.
The UTHSC research team has developed what promises to be a more
sensitive and more immediate
way to monitor the effectiveness of a
treatment. Their new near-infrared fluorescence imaging technique
examines the root cause of lymphedema: blockages or damages in the
lymphatic system that prevent
fluid from circulating through the
body and cause it to pool in the limbs.
"The lymphatics are like the
sewer system of your body," says Sevick. "If they get all plugged up, then
there's a flood."
Nine women - six with lymphedema and three
controls - were injected with a near-infrared fluorescent
dye that
has been used safely for 50 years at much higher dosages. The dye is taken up
by the
lymphatic system. When tissue surfaces are exposed to a dim,
near-infrared laser - harmless to the
human body - the dye within
fluoresces, revealing its transit through the lymphatic system.
"This is
the only method that can directly check for improvements in lymphatic function
in one sitting,
before and after a treatment," says
Sevick.
Physicians have several treatment options for controlling
lymphedema. They may use compression
bandages and massage limbs to
manually encourage fluids to drain from the arm. Pneumatic
compression devices, sleeves made of segmented chambers that inflate
and squeeze, may provide a
similar benefit at home, but they may
not always be covered by Medicare reimbursements because of
lacking
direct evidence of their benefit.
"The problem is that there has been no
good way to measure direct evidence of benefit," says Sevick.
"Hopefully we can use near-infrared fluorescence imaging technique to
show improved lymphatic
function from these treatments."
The
NIR fluorescence technique detected statistically significant improvements in
fluid flow through the
lymphatic system immediately after the use of
pneumatic compression devices. A larger follow-up study
will be
needed to confirm the results of this pilot study, says Sevick.
The
research was funded by the National Institutes of Health and by Tactile Systems
Technology, Inc.,
which manufactures and markets the Flexitouch
pneumatic compression devices tested in this research.
The
paper:
"Direct evidence of lymphatic function improvement after advanced
pneumatic compression device
treatment of lymphedema" by Kristen E.
Adams et al.
Source:
Lyndsay Basista
Optical Society of
America
August 12, 2010 - HemaQuest Pharmaceuticals Initiates Phase
2 Clinical Trial In EBV-Related
Malignancies
-
HemaQuest Pharmaceuticals announced that it has initiated the
Company's Phase 2 clinical trial
evaluating its proprietary
HQK-1004 therapy for the treatment of lymphomas and related cancers
associated with Epstein-Barr virus (EBV) infection. These EBV-related
cancers have poor prognoses
and short patient survival. Currently
available cancer therapies are typically much less effective in
patients with EBV-related lymphoid malignancies than in patients who
have similar cancers not infected
with the virus.
In a Phase
1 clinical trial previously conducted by HemaQuest's scientific founders, 15
patients with
relapsed or refractory EBV-related lymphomas were
treated with a 3-week infusion of our proprietary
therapy, HQK-1004
and the anti-viral drug, Ganciclovir (GCV). Ten patients (67% response rate)
demonstrated objective tumor responses, including several patients
with complete tumor responses.
This study provided support for
previous laboratory studies demonstrating that HQK 1004 makes
EBV
infected cancers susceptible to antiviral therapy.
HQK-1004 acts by
inducing the expression of a gene for a viral protein that is the target of
several
common anti-viral drugs, including GCV, which eradicate
virally infected cells. The gene that makes this
target protein is
present in EBV infected tumor cells, but it is not expressed, thus rendering
these cells
resistant to anti-viral therapeutics. To overcome this
problem, HemaQuest has developed a proprietary
therapeutic approach
using HQK-1004, which enables the expression of the viral protein that is the
target of anti-viral drugs. Combining HQK-1004 with anti-viral
therapeutics now enables the killing of
viral-infected tumor cells,
while uninfected cells should not be affected.
In the current
Company-sponsored Phase 2 clinical trial, up to 40 patients with advanced
EBV-related
lymphoid malignancies will be treated with HQK-1004 and
GCV at several clinical sites in the US and
abroad. The trial will
test whether a shorter, 5-day infusion of HQK-1004 can reproduce the promising
results documented in the first clinical trial. With positive
clinical results, the Company plans additional
studies to obtain
FDA approval for this clinical indication. In addition, HemaQuest intends to
test this
therapeutic approach to treat other viral-related
cancers.
"This trial represents an important step forward in the
development of our HQK-1004 therapy and
builds on the existing
clinical safety and efficacy data," commented Susan Perrine, MD, Chief
Scientific
Officer and VP of Clinical Affairs at HemaQuest. "Our
targeted therapy represents a novel approach to
treating
viral-related cancers, which include up to 20% of malignancies. By targeting
the virus
associated with the tumor cells, the toxic side effects
that commonly occur with traditional
chemotherapy are potentially
avoided."
Added Ronald Berenson, MD, President and Chief Executive
Officer of HemaQuest, "We are very
pleased to announce the start of
this global Phase 2 trial. HQK-1004 has the potential to improve the
outcome
of patients with EBV lymphoid malignancies, most of whom have poor responses
and limited
survival with current therapies. If this trial is successful, it could lead to a new approach to treating viral-
related cancers, including other hematologic malignancies as well as
solid tumors."
Source: HemaQuest Pharmaceuticals
August 24,
2010 - Two-Year Data From Phase 2 Trial Of Genzyme's Eliglustat Tartrate For
Gaucher
Disease To Be Published In The Journal Blood
-
Genzyme Corporation (NASDAQ: GENZ) announced that the two-year
follow-up results from the
phase 2 clinical trial of its
investigational therapy known as eliglustat tartrate have been accepted for
publication in the journal Blood. The results have been pre-published on
the journal's website and are
available to
subscribers.
Eliglustat tartrate, a capsule taken orally, is being
developed to provide a convenient treatment
alternative for adult
patients with Gaucher disease type 1, and to offer a broader range of treatment
options for patients and physicians to achieve individual
therapeutic goals. Current treatments, including
Genzyme's
Cerezyme® (imiglucerase for injection), the standard of care for patients with
Gaucher
disease type 1, are administered through intravenous
infusions.
Genzyme reported last year that the 52-week phase 2 trial of
eliglustat tartrate had met its primary
composite endpoint: a
clinically meaningful response in at least two of three endpoints (improvements
in
spleen size, hemoglobin and platelet levels) in individual
patients. The two-year data to be published in
Blood indicate
continued improvements across all endpoints. After two years, most patients
(85%) had
met at least three of the four hematologic and visceral
therapeutic goals established for enzyme
replacement therapy. These
data also suggest that eliglustat tartrate may positively impact two
indicators
of bone disease, bone mineral density and the presence of dark
marrow.
The most common adverse events reported in greater than 10
percent of patients included viral
infections (six patients),
urinary tract infections, increased blood pressure, and abdominal pain (three
patients each). Eight drug-related adverse events, including one
serious event, were reported in six
patients. All were mild in
severity.
These two-year results were presented at the Lysosomal Disease
Network WORLD Symposium
earlier this year.
Phase 3
Program
Genzyme is currently enrolling patients in three global,
multi-center, phase 3 trials of eliglustat tartrate.
Combined, more
than 450 patients are expected to participate, making this the largest clinical
program
ever focused on Gaucher disease. Over 50 sites in more than
25 countries are currently participating,
with additional centers
planned.
The first phase 3 trial, ENCORE, is a randomized, open-label
study for adult patients with Gaucher
disease type 1, designed to
compare eliglustat tartrate to Cerezyme. Adult patients who have
previously received enzyme replacement therapy for at least three years
and have reached their
therapeutic goals may qualify for this
trial. The second trial, ENGAGE, is a randomized, double-blind,
placebo-controlled study for patients with a confirmed diagnosis of
Gaucher disease type 1. Patients
who have not received enzyme
replacement therapy within 9 months or substrate reduction therapy
within 6 months of participation may qualify for this study. Genzyme
recently launched a third trial,
known as EDGE, to compare
once-daily dosing of eliglustat tartrate with twice-daily dosing.
Breast
Cancer Survivors Don't Need To Be Afraid Of Air Travel: U Of A Study - 21
August 2010
University of Alberta researcher Margie McNeely says results
from an international study she was part
of indicates certain
precautions about the risk of lymphedema for breast cancer survivors are
outdated.
McNeely, from the Faculty of Rehabilitation Medicine, says
women who've had breast cancer surgery
are often warned that
pressure changes in an airplane cabin could trigger lymphedema, chronic
swelling
in the arm. But the study she did with an Australian
research team showed that only five per cent of
these women are
likely at risk of developing any arm swelling when flying.
The caution
about lymphedema risk is for women who have had lymph nodes removed from the
armpit, a common procedure during cancer treatment. McNeely says
because these lymph nodes help
drain fluid when they are removed
there is the potential for chronic swelling.
McNeely teamed up with
Australian researcher Sharon Kilbreath to study the effect of air travel on 60
Canadian breast cancer survivors who were flying to Australia for an
International Dragon Boat
Festival. Seventeen of these women were
from Edmonton. The study also involved a group of 12
women who were
travelling to the festival from different areas of Australia.
The
researchers compared both of the participants' arms, the arm where lymph nodes
were removed
from the armpit and the opposite unaffected arm, with
a device that can detect subtle changes in fluid
difference between
the arms. The measurements were done in Canada before they left and again in
Australia when they arrived.
Findings indicate that 95 per
cent of the women had no arm swelling. Four women had a slight increase
but at a follow-up test, done six weeks after the women returned to
Canada, three were back to
normal and only one woman was found at
possible risk for chronic swelling.
McNeely says that, until now,
information about air travel and lymphedema risk has not been based on
solid evidence, but says this research shows that while there is a risk
of developing lymphedema during
flight, that risk is very
low.
McNeely's research was published in the journal Breast Cancer
Research and Treatment.
August 27, 2010 - Shire Announces
European Approval Of VPRIV(R) (velaglucerase Alfa) For The
Treatment Of Type 1 Gaucher Disease –
Shire plc (LSE:
SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company,
announced
that the European Commission has granted marketing authorisation for VPRIV(R)
(velaglucerase alfa), a human cell line derived enzyme replacement
therapy (ERT) for the long-term
treatment of type 1 Gaucher
disease. VPRIV has been authorized as an orphan medicine through the
Centralised
Procedure, making it available in 30 countries across Europe.
This
approval was based on data from Shire's velaglucerase alfa clinical development
programme
which represents the largest and most comprehensive
clinical data set supporting registration for an
ERT for type 1
Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10
countries around
the world participated in the clinical studies, all
of which met their primary endpoints.
"Gaucher disease is a rare and
often debilitating condition," said Professor Tim Cox from the
Department of Medicine, University of Cambridge, and founder of the
largest U.K. Gaucher clinic at
Addenbrooke's Hospital. "The European
approval of VPRIV is important in that we now have an
alternative,
licensed therapeutic enzyme. For type 1 patients the availability of VPRIV
provides further
opportunities to individualise treatment options
for this complex disorder."
Across Europe, hundreds of type 1 Gaucher
patients have been receiving velaglucerase alfa through
early
access programmes, developed in partnership with national authorities, Gaucher
expert physicians
and patient associations. Globally there are over
850 patients on velaglucerase alfa and demand
continues to be
strong. As a result, Shire has implemented a program to carefully monitor
demand and
manage requests from physicians and patients in order to
ensure long-term, uninterrupted treatment
with VPRIV.
"The
Marketing Authorisation for VPRIV in the EU is an important milestone for
Shire," said Sylvie
Gregoire, President, Shire Human Genetic
Therapies. "Our efforts to accelerate our manufacturing,
clinical
and regulatory timelines have resulted in VPRIV's approval in Europe and the US
months ahead
of schedule."
Important Safety
Information
The most serious adverse reactions in patients treated with
VPRIV were hypersensitivity reactions.
Infusion-related reactions were
the most commonly observed adverse reactions in patients treated with
VPRIV
in clinical studies. The most commonly observed symptoms of infusion-related
reactions were:
headache, dizziness, hypotension, hypertension,
nausea, fatigue/asthenia, and pyrexia. Generally the
infusion-related reactions were mild and, in treatment-naive patients,
onset occurred mostly during the
first 6 months of treatment and
tended to occur less frequently with time. Other commonly observed
adverse reactions in >10% of patients were: abdominal pain, back
pain, joint pain, upper respiratory
tract infection, and activated
partial thromboplastin time prolonged. Adverse reactions more commonly
seen in paediatric patients (>10% difference) included upper
respiratory tract infection, rash, activated
partial thromboplastin
time prolonged, and pyrexia. In clinical trials one patient developed
neutralizing
antibodies.
September 1, 2010 - BioMarin
Receives Orphan Drug Designation From The FDA For BMN-701
For The
Treatment Of Pompe Disease -
BioMarin Pharmaceutical Inc.
(Nasdaq: BMRN) announced that it has received orphan drug
designation from the U.S. Food and Drug Administration (FDA) for
BMN-701, a novel fusion of
insulin-like growth factor 2 and alpha
glucosidase (IGF2-GAA) in development for the treatment of
Pompe
disease. An investigational new drug application (IND) for BMN-701 has been
submitted,
investigational material has been manufactured and a
Phase I/II study is expected to start in the first
quarter of
2011.
"Receiving orphan drug designation from the FDA for BMN-701 is a
significant milestone for our
Pompe program. As part of their
assessment for designation, the FDA determined that BMN-701 is
sufficiently different from alglusidase alfa (Myozyme/Lumizyme) to allow
for a unique orphan
designation. For this reason, clinical
superiority over alglusidase alfa will not be necessary to secure
orphan exclusivity for BMN-701," said Jean-Jacques Bienaime, Chief
Executive Officer of BioMarin.
"This emphasizes our mission of
developing innovative, products for orphan diseases with an unmet
medical need. We believe BMN-701 has the potential to possibly deliver
more enzyme to lysosomes
compared to traditional mannose-6-phosphate
targeted approaches using the recently acquired GILT
technology."
About Pompe Disease
Pompe disease, a
lysosomal storage disorder, is a progressive degenerative disease of the heart
muscle, diaphragm and skeletal muscle. It is caused by a deficiency
in the lysosomal enzyme acid alpha
glucosidase which leads to the
accumulation of glycogen in myocyte lysosomes and results in cell death.
The incidence is one in 40,000 births. There are two main forms of
Pompe disease: adult onset with an
incidence of one in 57,000 births
and infantile onset with an incidence of one in 138,000 births. The
current standard of care is Genzyme's Myozyme and Lumizyme. Prognosis
with standard of care is
stabilization of the disease or minor
improvements for the majority of adult onset patients.
About
BioMarin
BioMarin develops and commercializes innovative
biopharmaceuticals for serious diseases and medical
conditions. The
company's product portfolio comprises four approved products and multiple
clinical
and pre-clinical product candidates. Approved products
include Naglazyme® (galsulfase) for
mucopolysaccharidosis VI (MPS
VI), a product wholly developed and commercialized by BioMarin;
Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product
which BioMarin developed
through a 50/50 joint venture with Genzyme
Corporation; Kuvan® (sapropterin dihydrochloride)
Tablets, for
phenylketonuria (PKU), developed in partnership with Merck Serono, a division
of Merck
KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine
phosphate), which has been approved
by the European Commission for
the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).
Other
product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is
currently in
clinical development for the treatment of MPS IVA and
PEG-PAL (PEGylated recombinant
phenylalanine ammonia lyase), which
is currently in Phase II clinical development for the treatment of
PKU.
A Century-Old Puzzle Comes Together, Scientists ID
Potential Protein Trigger In Lung Disease
Sarcoidosis - 04 May
2010
Lung researchers at Johns Hopkins have identified a possible
protein trigger responsible for
sarcoidosis, a potentially fatal
inflammatory disease marked by tiny clumps of inflammatory cells that
each
year leave deep, grainy scars on the lungs, lymph nodes, skin and almost all
major organs in
hundreds of thousands of Americans.
The
disorder, whose cause has been a persistent mystery for nearly a century,
strikes mostly young
adults and disproportionately affects African
Americans.
The link between sarcoidosis and overproduction of the
suspected protein trigger, called serum amyloid
A, was revealed
after a six-year investigation encompassing more than two dozen laboratory
experiments, including some on diseased lung tissue samples from 86
patients in the Baltimore area.
"The increase in production of serum
amyloid A explains for the first time how inflammation can persist
in the lungs without being triggered by an active infection," says
study senior investigator and
pulmonologist David Moller, M.D., a
professor at the Johns Hopkins University School of Medicine.
Moller is also director of the sarcoidosis clinic at The Johns Hopkins
Hospital.
Study lead investigator Edward Chen, M.D., says the new
findings also clear the path for developing
drug treatments or
vaccines that can block serum amyloid A from binding to cell receptors and
kicking
off inflammation.
In the short term, however, Moller
says his team has plans to use the study results to create diagnostic
tests
that could better predict which people with the disease are likely to heal on
their own or are more
likely to suffer persistent inflammation,
which can lead to scarring, difficulty breathing, and heart failure
that can only be fixed by lung transplantation.
In a report
published in February in the American Journal of Respiratory and Critical Care
Medicine,
the Johns Hopkins scientists described their research on
what was behind the microscopic clusters of
inflamed tissue and
white blood cells, or granulomas, which are a defining feature of
sarcoidosis.
Such lung lesions are not unique to sarcoidosis and can be
triggered by infections, such as in
tuberculosis, which is often
confused with sarcoidosis. But unlike tuberculosis, sarcoidosis is not an
infectious disease, does not yield to antibiotics, and is not limited
to any particular organ, occurring as
well in the eyes, skin, brain,
heart and liver.
Of particular interest to researchers was the role
played by so-called amyloids, a set of proteins known
to cause
other persistent inflammatory conditions, such as amyloidosis. Indeed, a
different kind of
amyloid has been tied to plaques in the brain
tissue of people with Alzheimer's disease.
Key among the researchers'
findings in sarcoidosis patients was that serum amyloid A stood out
because it was heavily concentrated within the granulomas in diseased
and scarred lung tissue.
Researchers found the protein a hundred to
a thousand times more widespread in sarcoidosis tissue
samples than
in samples from people with tuberculosis, another granuloma-forming lung
disease.
Similarly elevated amyloid levels were seen in comparison
tests with tissue samples from people with
lung cancer and Crohn's
disease.
Further tests in patients' lung cell cultures showed that
adding serum amyloid A spiked production of at
least a half-dozen
key inflammatory chemicals known to be involved in damaging tissue.
In
another series of experiments in mice, the team discovered that granuloma
formation in the lungs
sped up when the mice were given injections
of synthetic serum amyloid A. Mice had previously been
injected with
specially coated plastic beads designed to trigger sarcoidosis-like lesions.
Adding the
synthetic protein led to the same biochemical reactions
in the mice as observed in humans, suggesting to
the researchers
that serum amyloid A played a key role in triggering sarcoidosis.
To
better understand how serum amyloid A might be driving granuloma formation, the
team used
special antibodies to block various cell surface receptor
sites where the protein would bind to the white
blood cells and spur
inflammation. Tests in human lung cells showed that blocking one particular
receptor, toll-like receptor-2 (TLR2), inhibited the sustained
inflammatory reaction typically associated
with sarcoidosis. But
when left to bind on its own, without an antibody blocking TLR2, the open
receptor could attach to serum amyloid A, and raised production of
inflammatory chemicals would
ensue.
"Not only have we shown
that serum amyloid A is a key protein trigger in sarcoidosis, but we also have
evidence that the resulting inflammation is dependent on binding
the protein at toll-like receptor-2,
which opens up a host of
possibilities that drugs blocking this binding site could prove an effective
treatment for this disease," says Chen, an assistant professor at
Johns Hopkins.
Funding support for the report and research was provided
by the National Institutes of Health, the
American Thoracic
Society, the Foundation for Sarcoidosis Research, the Life and Breath
Foundation,
and the Hospital for the Consumptives of Maryland
(Eudowood.)
In addition to Moller and Chen, other Johns Hopkins
researchers involved in this study were Zhimin
Song, M.D.; Matthew
Willett, B.S.; Shannon Heine, B.S.; Rex Yung, M.D.; Mark Liu, M.D.; Steve
Groshong, M.D., Ph.D.; Ying Zhang, M.D., Ph.D.; and Rubin Tuder,
M.D.
Source: Johns Hopkins Medicine
------------
June
25, 2010 - Decongestive Physiotherapy Helps Patients With Painful Leg Swelling
–
For patients with painful swelling of the legs caused by
chronic venous insufficiency (CVI), a
combination treatment
approach called "complete decongestive physiotherapy" improves symptoms,
walking ability, and quality of life, reports a study in Topics in
Geriatric Rehabilitation. The journal is
published by Lippincott
Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of
information and business intelligence for students, professionals,
and institutions in medicine, nursing,
allied health, and
pharmacy.
Complete (or "complex") decongestive physiotherapy (CDP) can
greatly reduce leg swelling and pain
in patients with CVI, according
to the new study, led by Yesim Bakar, Ph.D., P.T., of Abant Izzet
Baysal University in Bolu, Turkey. Another paper in the same issue of
TGR shows similar benefits of
CDP in a patient with lymphatic
obstruction (lymphedema) related to the skin condition
psoriasis.
Complete Decongestive Physiotherapy Brings Good
Results
Dr Bakar and coauthors evaluated the effects of CDP in 62 older
adults (average age 65 years) with
CVI. Patients with CVI have poor
blood flow in the veins of the leg, leading to fluid buildup. This
results in painful swelling, making it difficult for patients to walk
and perform other activities. Usually
only one leg is
affected.
All patients were treated using the CDP approach, which
combines four types of physical therapy
treatments:
--
Manual lymph drainage massage to promote drainage of the lymph nodes.
--
Skin care moisturizers and other treatments for skin changes caused by poor
circulation.
-- Compression bandages are applied to prevent fluid from
reaccumulating.
-- Exercise simple leg exercises to improve blood flow
and leg motion.
For the first month, patients met with a physical
therapist five days a week for treatment. They also
received
education in performing each of the four types of therapy for themselves. The
goal was to
keep fluid buildup under control through lifelong,
daily self-care.
The CDP treatment program dramatically reduced leg
swelling on average, fluid buildup in the affected
leg decreased by
the equivalent of nearly half a liter. Pain was also decreased, from an average
score of
67 to 18 on a 100-point scale. Patients had improved
walking ability, less pain when walking, and
improved ability to
perform daily activities. The authors believe that including exercise in the
treatment
program was a key factor in improving walking
ability.
Dr. Bakar is also a co-author of the other paper, which reports
on the use of CDP in a woman with
lymphedema related to the chronic
skin condition psoriasis. In patients with lymphedema, obstruction of
the
lymph nodes causes similar symptoms of leg pain and swelling. In both the short
and long term,
CDP brought significant improvement in pain,
swelling, and activity.
Inconclusive Results From Research Into
Biologics-Associated Cancer Risk - 18 June 2010
Biologics-naive
Juvenile Idiopathic Arthritis (JIA) patients may have an increased risk of
cancer
compared with the general Swedish population, according to
research presented at EULAR 2010, the
Annual Congress of the
European League Against Rheumatism in Rome, Italy. Results of an additional
study, which researched a small cohort of patients showed an increased
frequency of cancer in those
receiving the biologic etanercept,
however, results were deemed not statistically significant by
researchers.
The results of a population-based Swedish cohort
study found that the incidence of cancer among
paediatric patients
with JIA identified during the last 40 years was comparable to that seen in the
general population, (0.5 vs. 0.4 cases per 1000 person years,
Relative Risk (RR)=1.1, 95%CI 0.9-
1.5). Subset analyses however
indicated that subjects diagnosed with JIA since 1987 (the year that the
Swedish patient registry attained nationwide coverage) were at elevated
risk of developing cancer
(RR=2.3, 95%CI 1.2-4.4, 13 JIA cancers
vs. 30 in comparator), attributed to an increased
occurrence of
cancers of the lymphatic system (RR=4.2, 95%CI 1.7-10.7, 8 cancers in JIA vs.
10 in
comparator).
"These results are intriguing and suggest
that in the past 20 years, patients with JIA not treated with
biological therapies appear to have an elevated risk of cancer compared
with the general population,"
said lead author of the study Dr.
Julia Simard, Clinical Epidemiology Unit, Karolinska Institute,
Stockholm, Sweden. "The results of our study indicate that evaluation
of cancer risks with biologics in
paediatric populations need to
factor in differences in incidence of cancer between these patients and
the general population. From a clinical point of view, it should be
remembered that although we noted
an increased risk in relative
terms, the excess risks remain low in absolute terms."
The Swedish study
assessed a national JIA cohort of 9,020 patients. For each JIA patient, up to
five
general-population comparators were identified (n=44,858). In
the biologics-naïve JIA cohort, 60
cancers were observed during
131,144 person-years compared to 266 cancers during 661,758
person-years in the population comparator. Researchers noted that
sensitivity analyses did not reveal
an explanation for the
differences seen between patients identified before and after 1987.
The
results of the second study combined data on 1,721 patients treated with
etanercept from three
prospective JIA registries in Germany, the UK
and the US. Of the 1,641 patients who qualified for the
primary
analysis, two cancers were reported. Whilst this yielded a rate higher than
expected when
compared to the general population, it was not
statistically significant (RR estimated using a
Standardized
Incident Ratio (SIR) of 3.7 (0.5-13.4, 95%CI)). This is believed to be in part
due to the
low event rate. The interpretation of these findings may
be further limited by the fact that the
comparator rates were based
on a general population and not a biologics-naïve JIA population, as per
the Swedish study, which suggests this may indicate an increased
underlying risk of cancer.
Abstract Numbers: OP0086 &
OP0274
Source:
Caroline Butt
European League Against
Rheumatism
July 14, 2010 - Protalix BioTherapeutics Receives PDUFA
Date For Taliglucerase Alfa -
Protalix BioTherapeutics, Inc.
(NYSE-Amex: PLX), announced that the Company's New Drug
Application
(NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and
Drug
Administration (FDA). The FDA granted taliglucerase alfa a
standard review time of ten months,
assigning a Prescription Drug
User Fee Act (PDUFA) action date of February 25, 2011. Taliglucerase
alfa
is the Company's proprietary plant cell expressed recombinant form of human
Glucocerebrosidase
(GCD) which is being developed for the treatment
of Gaucher disease under a Special Protocol
Assessment (SPA) with
the FDA. Following the completion of a phase III clinical trial of
taliglucerase
alfa, the Company completed the submission of a
rolling NDA with the FDA in April 2010.
"If approved, taliglucerase alfa
will be an attractive and important therapeutic option for Gaucher
patients," said Dr. David Aviezer, President and Chief Executive
Officer of Protalix. "We look forward
to working closely with the
agency through this final stage of the review process."
Taliglucerase
alfa has been granted orphan drug designation from the FDA in the United
States. The
Company continues to make taliglucerase alfa available
to Gaucher patients in the United States under
an Expanded Access
protocol, as well as to patients in the European Union, Israel and other
countries
under Named Patient provisions.
About Gaucher
disease
Gaucher disease, an inherited condition, is the most prevalent
lysosomal storage disorder, with an
incidence of about 1 in 20,000
live births. People with Gaucher disease do not have enough of an
enzyme, beta-glucosidase (glucocerebrosidase), that breaks down a
certain type of fat molecule. As a
result, lipid engorged cells
(called Gaucher cells) amass in different parts of the body, primarily the
spleen, liver and bone marrow. Accumulation of Gaucher cells may cause
spleen and liver enlargement,
anemia, excessive bleeding and
bruising, bone disease and a number of other signs and symptoms.
About
Protalix
Protalix is a biopharmaceutical company focused on the
development and commercialization of
proprietary recombinant
therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalix's ProCellEx™ presents a proprietary method
for the expression of
recombinant proteins that Protalix believes
will allow for the cost-effective, industrial-scale production
of
recombinant therapeutic proteins in an environment free of mammalian components
and viruses.
Protalix is also advancing additional recombinant
biopharmaceutical drug development programs.
Taliglucerase alfa is
an enzyme replacement therapy in development under a Special Protocol
Assessment
with the FDA for Gaucher disease. Protalix filed a rolling NDA submission with
the FDA
in December 2009. In November 2009, Protalix granted Pfizer
Inc. exclusive, worldwide rights to
develop and commercialize
taliglucerase alfa for the treatment of Gaucher disease, except in Israel.
Protalix retained the right to commercialize taliglucerase alfa in
Israel.
August 5, 2010 - Ease The Aftermath Of Breast Cancer With
New Imaging Technique -
A new study of breast cancer survivors
may help physicians ease a common side effect of cancer
treatments.
The collaborative research by Eva Sevick, Ph.D., Director of the Center for
Molecular
Imaging at the University of Texas Health Science Center
in Houston (UTHSC), and Caroline Fife, M.
D., Director of the
Memorial Herman Wound Care Clinic at UTHSC, could bring relief to
millions.
Their paper appears in the inaugural issue of Biomedical
Optics Express, an online, open-access
journal published by the
Optical Society (OSA). The papers featured in the journal will encompass
theoretical modeling and simulations, technology development,
biomedical studies and clinical
applications.
A substantial
number of breast cancer survivors suffer from lymphedema in the aftermath of
their cancer
surgeries. In lymphedema, fluids accumulate in the
arms, potentially causing disfiguring and debilitating
swelling
that can impact quality of life.
Treatments vary, but they generally
consist of using manual and pneumatic therapies to "push" or
stimulate the body to remove excess fluid and reduce tissue swelling.
Finding out whether a treatment is
working can take months. That's
because the current method of assessing progress is to measure the
circumference or volume of a limb and check for changes in swelling -
and a size change big enough to
be measured takes
time.
During this time, the condition might improve - or it might
worsen.
The UTHSC research team has developed what promises to be a more
sensitive and more immediate
way to monitor the effectiveness of a
treatment. Their new near-infrared fluorescence imaging technique
examines the root cause of lymphedema: blockages or damages in the
lymphatic system that prevent
fluid from circulating through the
body and cause it to pool in the limbs.
"The lymphatics are like the
sewer system of your body," says Sevick. "If they get all plugged up, then
there's a flood."
Nine women - six with lymphedema and three
controls - were injected with a near-infrared fluorescent
dye that
has been used safely for 50 years at much higher dosages. The dye is taken up
by the
lymphatic system. When tissue surfaces are exposed to a dim,
near-infrared laser - harmless to the
human body - the dye within
fluoresces, revealing its transit through the lymphatic system.
"This is
the only method that can directly check for improvements in lymphatic function
in one sitting,
before and after a treatment," says
Sevick.
Physicians have several treatment options for controlling
lymphedema. They may use compression
bandages and massage limbs to
manually encourage fluids to drain from the arm. Pneumatic
compression devices, sleeves made of segmented chambers that inflate
and squeeze, may provide a
similar benefit at home, but they may
not always be covered by Medicare reimbursements because of
lacking
direct evidence of their benefit.
"The problem is that there has been no
good way to measure direct evidence of benefit," says Sevick.
"Hopefully we can use near-infrared fluorescence imaging technique to
show improved lymphatic
function from these treatments."
The
NIR fluorescence technique detected statistically significant improvements in
fluid flow through the
lymphatic system immediately after the use of
pneumatic compression devices. A larger follow-up study
will be
needed to confirm the results of this pilot study, says Sevick.
The
research was funded by the National Institutes of Health and by Tactile Systems
Technology, Inc.,
which manufactures and markets the Flexitouch
pneumatic compression devices tested in this research.
The
paper:
"Direct evidence of lymphatic function improvement after advanced
pneumatic compression device
treatment of lymphedema" by Kristen E.
Adams et al.
Source:
Lyndsay Basista
Optical Society of
America
August 12, 2010 - HemaQuest Pharmaceuticals Initiates Phase
2 Clinical Trial In EBV-Related
Malignancies
-
HemaQuest Pharmaceuticals announced that it has initiated the
Company's Phase 2 clinical trial
evaluating its proprietary
HQK-1004 therapy for the treatment of lymphomas and related cancers
associated with Epstein-Barr virus (EBV) infection. These EBV-related
cancers have poor prognoses
and short patient survival. Currently
available cancer therapies are typically much less effective in
patients with EBV-related lymphoid malignancies than in patients who
have similar cancers not infected
with the virus.
In a Phase
1 clinical trial previously conducted by HemaQuest's scientific founders, 15
patients with
relapsed or refractory EBV-related lymphomas were
treated with a 3-week infusion of our proprietary
therapy, HQK-1004
and the anti-viral drug, Ganciclovir (GCV). Ten patients (67% response rate)
demonstrated objective tumor responses, including several patients
with complete tumor responses.
This study provided support for
previous laboratory studies demonstrating that HQK 1004 makes
EBV
infected cancers susceptible to antiviral therapy.
HQK-1004 acts by
inducing the expression of a gene for a viral protein that is the target of
several
common anti-viral drugs, including GCV, which eradicate
virally infected cells. The gene that makes this
target protein is
present in EBV infected tumor cells, but it is not expressed, thus rendering
these cells
resistant to anti-viral therapeutics. To overcome this
problem, HemaQuest has developed a proprietary
therapeutic approach
using HQK-1004, which enables the expression of the viral protein that is the
target of anti-viral drugs. Combining HQK-1004 with anti-viral
therapeutics now enables the killing of
viral-infected tumor cells,
while uninfected cells should not be affected.
In the current
Company-sponsored Phase 2 clinical trial, up to 40 patients with advanced
EBV-related
lymphoid malignancies will be treated with HQK-1004 and
GCV at several clinical sites in the US and
abroad. The trial will
test whether a shorter, 5-day infusion of HQK-1004 can reproduce the promising
results documented in the first clinical trial. With positive
clinical results, the Company plans additional
studies to obtain
FDA approval for this clinical indication. In addition, HemaQuest intends to
test this
therapeutic approach to treat other viral-related
cancers.
"This trial represents an important step forward in the
development of our HQK-1004 therapy and
builds on the existing
clinical safety and efficacy data," commented Susan Perrine, MD, Chief
Scientific
Officer and VP of Clinical Affairs at HemaQuest. "Our
targeted therapy represents a novel approach to
treating
viral-related cancers, which include up to 20% of malignancies. By targeting
the virus
associated with the tumor cells, the toxic side effects
that commonly occur with traditional
chemotherapy are potentially
avoided."
Added Ronald Berenson, MD, President and Chief Executive
Officer of HemaQuest, "We are very
pleased to announce the start of
this global Phase 2 trial. HQK-1004 has the potential to improve the
outcome
of patients with EBV lymphoid malignancies, most of whom have poor responses
and limited
survival with current therapies. If this trial is
successful, it could lead to a new approach to treating viral-
related cancers, including other hematologic malignancies as well as
solid tumors."
Source: HemaQuest Pharmaceuticals
August 24,
2010 - Two-Year Data From Phase 2 Trial Of Genzyme's Eliglustat Tartrate For
Gaucher
Disease To Be Published In The Journal Blood
-
Genzyme Corporation (NASDAQ: GENZ) announced that the two-year
follow-up results from the
phase 2 clinical trial of its
investigational therapy known as eliglustat tartrate have been accepted for
publication in the journal Blood. The results have been pre-published on
the journal's website and are
available to
subscribers.
Eliglustat tartrate, a capsule taken orally, is being
developed to provide a convenient treatment
alternative for adult
patients with Gaucher disease type 1, and to offer a broader range of treatment
options for patients and physicians to achieve individual
therapeutic goals. Current treatments, including
Genzyme's
Cerezyme® (imiglucerase for injection), the standard of care for patients with
Gaucher
disease type 1, are administered through intravenous
infusions.
Genzyme reported last year that the 52-week phase 2 trial of
eliglustat tartrate had met its primary
composite endpoint: a
clinically meaningful response in at least two of three endpoints (improvements
in
spleen size, hemoglobin and platelet levels) in individual
patients. The two-year data to be published in
Blood indicate
continued improvements across all endpoints. After two years, most patients
(85%) had
met at least three of the four hematologic and visceral
therapeutic goals established for enzyme
replacement therapy. These
data also suggest that eliglustat tartrate may positively impact two
indicators
of bone disease, bone mineral density and the presence of dark
marrow.
The most common adverse events reported in greater than 10
percent of patients included viral
infections (six patients),
urinary tract infections, increased blood pressure, and abdominal pain (three
patients each). Eight drug-related adverse events, including one
serious event, were reported in six
patients. All were mild in
severity.
These two-year results were presented at the Lysosomal Disease
Network WORLD Symposium
earlier this year.
Phase 3
Program
Genzyme is currently enrolling patients in three global,
multi-center, phase 3 trials of eliglustat tartrate.
Combined, more
than 450 patients are expected to participate, making this the largest clinical
program
ever focused on Gaucher disease. Over 50 sites in more than
25 countries are currently participating,
with additional centers
planned.
The first phase 3 trial, ENCORE, is a randomized, open-label
study for adult patients with Gaucher
disease type 1, designed to
compare eliglustat tartrate to Cerezyme. Adult patients who have
previously received enzyme replacement therapy for at least three years
and have reached their
therapeutic goals may qualify for this
trial. The second trial, ENGAGE, is a randomized, double-blind,
placebo-controlled study for patients with a confirmed diagnosis of
Gaucher disease type 1. Patients
who have not received enzyme
replacement therapy within 9 months or substrate reduction therapy
within 6 months of participation may qualify for this study. Genzyme
recently launched a third trial,
known as EDGE, to compare
once-daily dosing of eliglustat tartrate with twice-daily dosing.
Breast
Cancer Survivors Don't Need To Be Afraid Of Air Travel: U Of A Study - 21
August 2010
University of Alberta researcher Margie McNeely says results
from an international study she was part
of indicates certain
precautions about the risk of lymphedema for breast cancer survivors are
outdated.
McNeely, from the Faculty of Rehabilitation Medicine, says
women who've had breast cancer surgery
are often warned that
pressure changes in an airplane cabin could trigger lymphedema, chronic
swelling
in the arm. But the study she did with an Australian
research team showed that only five per cent of
these women are
likely at risk of developing any arm swelling when flying.
The caution
about lymphedema risk is for women who have had lymph nodes removed from the
armpit, a common procedure during cancer treatment. McNeely says
because these lymph nodes help
drain fluid when they are removed
there is the potential for chronic swelling.
McNeely teamed up with
Australian researcher Sharon Kilbreath to study the effect of air travel on 60
Canadian breast cancer survivors who were flying to Australia for an
International Dragon Boat
Festival. Seventeen of these women were
from Edmonton. The study also involved a group of 12
women who were
travelling to the festival from different areas of Australia.
The
researchers compared both of the participants' arms, the arm where lymph nodes
were removed
from the armpit and the opposite unaffected arm, with
a device that can detect subtle changes in fluid
difference between
the arms. The measurements were done in Canada before they left and again in
Australia when they arrived.
Findings indicate that 95 per
cent of the women had no arm swelling. Four women had a slight increase
but at a follow-up test, done six weeks after the women returned to
Canada, three were back to
normal and only one woman was found at
possible risk for chronic swelling.
McNeely says that, until now,
information about air travel and lymphedema risk has not been based on
solid evidence, but says this research shows that while there is a risk
of developing lymphedema during
flight, that risk is very
low.
McNeely's research was published in the journal Breast Cancer
Research and Treatment.
August 27, 2010 - Shire Announces
European Approval Of VPRIV(R) (velaglucerase Alfa) For The
Treatment Of Type 1 Gaucher Disease –
Shire plc (LSE:
SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company,
announced
that the European Commission has granted marketing authorisation for VPRIV(R)
(velaglucerase alfa), a human cell line derived enzyme replacement
therapy (ERT) for the long-term
treatment of type 1 Gaucher
disease. VPRIV has been authorized as an orphan medicine through the
Centralised
Procedure, making it available in 30 countries across Europe.
This
approval was based on data from Shire's velaglucerase alfa clinical development
programme
which represents the largest and most comprehensive
clinical data set supporting registration for an
ERT for type 1
Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10
countries around
the world participated in the clinical studies, all
of which met their primary endpoints.
"Gaucher disease is a rare and
often debilitating condition," said Professor Tim Cox from the
Department of Medicine, University of Cambridge, and founder of the
largest U.K. Gaucher clinic at
Addenbrooke's Hospital. "The European
approval of VPRIV is important in that we now have an
alternative,
licensed therapeutic enzyme. For type 1 patients the availability of VPRIV
provides further
opportunities to individualise treatment options
for this complex disorder."
Across Europe, hundreds of type 1 Gaucher
patients have been receiving velaglucerase alfa through
early
access programmes, developed in partnership with national authorities, Gaucher
expert physicians
and patient associations. Globally there are over
850 patients on velaglucerase alfa and demand
continues to be
strong. As a result, Shire has implemented a program to carefully monitor
demand and
manage requests from physicians and patients in order to
ensure long-term, uninterrupted treatment
with VPRIV.
"The
Marketing Authorisation for VPRIV in the EU is an important milestone for
Shire," said Sylvie
Gregoire, President, Shire Human Genetic
Therapies. "Our efforts to accelerate our manufacturing,
clinical
and regulatory timelines have resulted in VPRIV's approval in Europe and the US
months ahead
of schedule."
Important Safety
Information
The most serious adverse reactions in patients treated with
VPRIV were hypersensitivity reactions.
Infusion-related reactions were
the most commonly observed adverse reactions in patients treated with
VPRIV
in clinical studies. The most commonly observed symptoms of infusion-related
reactions were:
headache, dizziness, hypotension, hypertension,
nausea, fatigue/asthenia, and pyrexia. Generally the
infusion-related reactions were mild and, in treatment-naive patients,
onset occurred mostly during the
first 6 months of treatment and
tended to occur less frequently with time. Other commonly observed
adverse reactions in >10% of patients were: abdominal pain, back
pain, joint pain, upper respiratory
tract infection, and activated
partial thromboplastin time prolonged. Adverse reactions more commonly
seen in paediatric patients (>10% difference) included upper
respiratory tract infection, rash, activated
partial thromboplastin
time prolonged, and pyrexia. In clinical trials one patient developed
neutralizing
antibodies.
September 1, 2010 - BioMarin
Receives Orphan Drug Designation From The FDA For BMN-701
For The
Treatment Of Pompe Disease -
BioMarin Pharmaceutical Inc.
(Nasdaq: BMRN) announced that it has received orphan drug
designation from the U.S. Food and Drug Administration (FDA) for
BMN-701, a novel fusion of
insulin-like growth factor 2 and alpha
glucosidase (IGF2-GAA) in development for the treatment of
Pompe
disease. An investigational new drug application (IND) for BMN-701 has been
submitted,
investigational material has been manufactured and a
Phase I/II study is expected to start in the first
quarter of
2011.
"Receiving orphan drug designation from the FDA for BMN-701 is a
significant milestone for our
Pompe program. As part of their
assessment for designation, the FDA determined that BMN-701 is
sufficiently different from alglusidase alfa (Myozyme/Lumizyme) to allow
for a unique orphan
designation. For this reason, clinical
superiority over alglusidase alfa will not be necessary to secure
orphan exclusivity for BMN-701," said Jean-Jacques Bienaime, Chief
Executive Officer of BioMarin.
"This emphasizes our mission of
developing innovative, products for orphan diseases with an unmet
medical need. We believe BMN-701 has the potential to possibly deliver
more enzyme to lysosomes
compared to traditional mannose-6-phosphate
targeted approaches using the recently acquired GILT
technology."
About Pompe Disease
Pompe disease, a
lysosomal storage disorder, is a progressive degenerative disease of the heart
muscle, diaphragm and skeletal muscle. It is caused by a deficiency
in the lysosomal enzyme acid alpha
glucosidase which leads to the
accumulation of glycogen in myocyte lysosomes and results in cell death.
The incidence is one in 40,000 births. There are two main forms of
Pompe disease: adult onset with an
incidence of one in 57,000 births
and infantile onset with an incidence of one in 138,000 births. The
current standard of care is Genzyme's Myozyme and Lumizyme. Prognosis
with standard of care is
stabilization of the disease or minor
improvements for the majority of adult onset patients.
About
BioMarin
BioMarin develops and commercializes innovative
biopharmaceuticals for serious diseases and medical
conditions. The
company's product portfolio comprises four approved products and multiple
clinical
and pre-clinical product candidates. Approved products
include Naglazyme® (galsulfase) for
mucopolysaccharidosis VI (MPS
VI), a product wholly developed and commercialized by BioMarin;
Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product
which BioMarin developed
through a 50/50 joint venture with Genzyme
Corporation; Kuvan® (sapropterin dihydrochloride)
Tablets, for
phenylketonuria (PKU), developed in partnership with Merck Serono, a division
of Merck
KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine
phosphate), which has been approved
by the European Commission for
the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).
Other
product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is
currently in
clinical development for the treatment of MPS IVA and
PEG-PAL (PEGylated recombinant
phenylalanine ammonia lyase), which
is currently in Phase II clinical development for the treatment of
PKU.