Company Press Release
SOURCE: Thomas Jefferson University
http://biz.yahoo.com/prnews/990721/pa_jeffers_1.html
Jefferson Scientist Begins Clinical Trial to Study Promising Parkinson's
Disease Drug; GM1 Ganglioside May Improve Symptoms, Delay Disease Advance
PHILADELPHIA, July 21, 1999 /PRNewswire/ -- Scientists at Jefferson Medical
College, armed with a newly awarded $2.4 million grant from the National
Institutes of Health, hope to find out whether a promising, drug, GM1
ganglioside, can improve symptoms, delay disease progression, and in some
cases actually restore damaged brain cells in Parkinson's disease patients.
Jay S. Schneider, Ph.D., professor of pathology, cell biology and anatomy
and neurology at Thomas Jefferson University in Philadelphia, will lead a
five-year clinical trial involving 150 patients. The Study will compare the
effectiveness of GM1 ganglioside -- a naturally occurring substance in the
nerve cell's membrane that plays an important role in cell growth,
development, and repair -- to standard Parkinson's disease treatments, which
improve symptoms, but do not alter the disease process.
``We hope that we will be able to do something no one else has done
before -- to stimulate remaining brain cells to sprout new nerve endings and
rescue other cells that might otherwise die,'' says Dr. Schneider, who last
year published evidence in the journal Neurology showing that GM1 may
improve symptoms in Parkinson's disease patients and perhaps even help slow
progression of the disease.
``If we are able to show that we've stimulated repair and regrowth in humans
as we and others have done in the laboratory, we will have evidence for the
first time of a therapy that can help restore the part of the nervous system
damaged by a neurodegenerative disease,'' Dr. Schneider says.
Fidia SpA of Abano Terme, Italy, which manufactures GM1 ganglioside under
the name Sygen®, will supply the drug for the study.
``Current therapies for Parkinson's disease treat only the symptoms and do
little to address the underlying disease process,'' Dr. Schneider explains.
``Despite the fact that you can alleviate some symptoms for a time, the
disease process continues. It's a progressive neurodegenerative disorder.
GM1 has the potential to be a disease-altering therapy.''
The Jefferson team is collaborating with scientists at the University of
Pennsylvania in Philadelphia to perform a special type of imaging called
single photon emission computed tomography, or SPECT. SPECT will allow the
team to visualize the number of dopamine terminals in the striatum, the part
of the brain that receives dopamine from the substantia nigra, which is the
brain region that dies in Parkinson's disease. Comparing patient symptoms
and the number of dopamine terminals is a significant advance, notes Dr.
Schneider. ``This technology will give us important new insights into the
relationship between the expression of the symptoms of Parkinson's disease
and the actual amount of dopamine terminals in the brain and will help us
better track the progression of the disease.''
The study is a randomized, double-blind placebo controlled trial in which
neither the researchers nor the patients know who receives the drug. The
participants, patients with mild to moderate Parkinson's disease, will be
divided into three groups of 50 each. One group will receive the drug during
the first two study phases. Another 50 will receive a placebo during phase
one, and will be allowed to take the drug later in the second trial phase. A
third control group of 50 will receive neither the study medication nor
placebo, but will receive standard Parkinson's therapy. This latter group
will have the option of receiving study medication when the study period
ends.
``We're hoping that in the first six months of the study we'll see the same
kind of symptomatic improvement we've seen in previous studies with GM1, as
well as a small increase in the number of dopamine terminals shown in
subsequent SPECT scans,'' Dr. Schneider says.
``The second part of the trial will examine whether long-term use of GM1
actually influences the course of Parkinson's,'' he says. This study phase
will address the question of whether a difference exists between the rate of
symptom advancement and loss of dopamine terminals in GM1 versus
non-GM1-treated patients.
For more information about participating in the clinical trial, please call
1-800-JEFF-NOW.
Copyright © 1999 PRNewswire
--
Judith Richards, London, Ontario, Canada
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