Sustained Immunological Effects Of Copaxone (Glatiramer Acetate
Injection) In Patients With MS Treated Over Six Years
Sommario:
Il Copaxone continua a mostrare benefici clinici dopo più di
6 anni di trattamento. Questo è il risultato dello studio pubblicato su Journal
of the Neurological Sciences di settembre 2002. Lo studio ha valutato gli
effetti del Copaxone a breve termine e a lungo termine sul sistema immunitario
di pazienti con Sclerosi Multipla tipo relapsing-remitting. Il meccanismo di
azione del farmaco non è ancora ben noto, sebbene si creda che possa ridurre la
risposta infiammatoria contro la mielina inducendo una risposta dei linfociti
Th2 che produrrebbero citochine anti-infiammatorie.
KANSAS CITY, MO -- September 25, 2002 --
Copaxone® (glatiramer acetate injection) continues to show benefit after more
than six years of treatment, according to a study published this month in the
Journal of the Neurological Sciences. The study evaluated the short-term and
long-term effects of Copaxone on the immune systems of people with
relapsing-remitting MS to see if the disease-modifying immune activity noted in
the first months of treatment were continued in patients treated with Copaxone
for up to nine years.
"The sustained response to Copaxone remains
based in inducing Th2 cells, the T-cells that can reduce the inflammation linked
to relapses in MS. This study shows that both patients treated for only a few
months as well as those treated for six to nine years show an increase in
Copaxone-reactive Th2 cells," said Suhayl Dhib-Jalbut, M.D., University of
Maryland School of Medicine, Baltimore.
The exact mode of action of Copaxone is not
completely understood but this study and others that preceded it provide insight
into how Copaxone affects the MS disease course. Researchers currently believe
that Copaxone-activated T-cells cross the blood-brain barrier, cross-react with
myelin antigens and consequently produce bystander suppression of inflammation
through the secretion of anti-inflammatory cytokines. More simply, bystander
suppression means that Copaxone, injected in the body, modifies the T-cells and
allows them to enter the brain where the MS attack is occurring. The Copaxone (glatiramer
acetate injection)-modified cells can then "tell" the cells attacking
the myelin to stop, or down-regulate the inflammatory activity.
In relapsing-remitting MS, the body's immune system
attacks the myelin proteins surrounding the nerves. Both the destruction of the
myelin and the resulting inflammation cause the damage that occurs in people
with MS. The goal of therapy is to stop or slow down the frequency of attacks,
and the areas of damage occurring in the brain.
This study compared 10 relapsing-remitting patients
treated for up to nine years as part of the pivotal Copaxone trial in the 1990s
to 10 patients who were tested pretreatment and after one to 10 months of
treatment with Copaxone. The findings confirm that the drug's disease-modifying
activity continues, indicating that the immunological effects are sustained for
more than six years.
The researchers believe further study on larger
patient groups can help further understand the mechanism of action of Copaxone
and provide insight into the correlation between immunologic effects and
clinical outcomes.
Copaxone is indicated for the reduction of the
frequency of relapses in relapsing-remitting MS. The most common side effects of
Copaxone are redness, pain, swelling, itching, or a lump at the site of
injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle
stiffness.
Copaxone is now approved in 40 countries worldwide,
including the U.S., Canada, Australia, Israel and all the European countries. In
Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd., and Aventis
Pharma. In North America, Copaxone is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd., headquartered
in Israel, is among the top 35 pharmaceutical companies in the world. More than
80 percent of Teva's sales are in North America and Europe. The company develops,
manufactures and markets generic and branded human pharmaceuticals and active
pharmaceutical ingredients. Teva's innovative R&D focuses on developing
novel drugs for diseases of the central nervous system.
Teva Neuroscience, Inc., is a subsidiary of Teva
Pharmaceutical Industries Ltd. Call 1-800/887-8100 or log onto http://www.copaxone.com/
for more information about Copaxone (glatiramer acetate injection) or multiple
sclerosis. Copaxone is a registered trademark of Teva Pharmaceutical Industries
Ltd. See additional important information at http://www.copaxone.com/pi
or call 1-800/887-8100 for electronic releases. For hardcopy releases, please
see enclosed full prescribing information.
This report contains forward-looking statements,
which express the beliefs and expectations of management. Such statements are
based on current expectations and involve a number of known and unknown risks
and uncertainties that could cause the company's future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include the impact of
pharmaceutical industry regulation, the difficulty of predicting FDA and other
regulatory authority approvals, the regulatory environment and changes in the
health policies and structure of various countries, acceptance and demand for
new pharmaceutical products and new therapies, the impact of competitive
products and pricing, the availability and pricing of ingredients used in the
manufacture of pharmaceutical products, uncertainties regarding market
acceptance of innovative products newly launched, currently being sold or in
development, the impact of restructuring of clients, reliance on strategic
alliances, fluctuations in currency, exchange and interest rates, operating
results, and other factors that are discussed in the company's annual report on
Form 20-F and the company's other filings with the U.S. Securities and Exchange
Commission.
SOURCE: Teva Neuroscience, Inc.
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