More MS news articles for May 2001

Teva Announced Global Study On COPAXONE -Glatiramer Acetate For Injection- Evaluates Largest Group Ever Of People With Primary Progressive Multiple Sclerosis -PPMS-

Thursday May 10  8:21am
Source: BusinessWire

JERUSALEM--(BUSINESS WIRE)--May 10, 2001--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the largest group of people with primary progressive multiple sclerosis (MS) ever studied has been enrolled in the PROMISE Trial, a three-year study to determine the safety and efficacy of COPAXONE(R) in PPMS.

At the American Academy of Neurology this month, researchers presented aggregate information about the enrolled patient group. The first look at the group's characteristics questions the sensitivity of recently proposed diagnostic criteria for primary progressive MS.

"This study gives us the chance to learn a significant amount about primary progressive MS. Just conducting the testing to enroll this large group of patients has caused us to take a closer look at the diagnostic criteria for PPMS," said Jerry S. Wolinsky, M.D., director of the MS Research Group at the University of Texas-Health Science Center.

The study enrolled 948 subjects at 59 clinical centers from the United States, Canada, United Kingdom, and France. The typical patient is 51 years old and just as likely to be male as female. The patient has been symptomatic for about 11 years and diagnosed for five years. From a clinical stand point, the average patient has an EDSS of 4.9, and a timed 25-foot walk of 12 seconds. About 20% of the enrollees do not have typical cerebral spinal fluid abnormalities.

COPAXONE(R) (glatiramer acetate for injection) is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump a the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Be sure to tell your doctor about any side effects.

Some patients report a short-term reaction right after injecting COPAXONE(R). This reaction can inolve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

COPAXONE(R) is not approved in the United States or other countries for treating primary progressive MS. This trial is intended to study the drug's effect in this patient population. The study is double-blind, placebo-controlled with clinical evaluations every three months, and an annual MRI over three years. The results of the therapeutic trial will not be available until early 2004.

Teva Pharmaceutical Industries, Ltd. was granted approval by the U.S. Food and Drug Administration (FDA) in December 1996, to market COPAXONE(R). The drug was launched in April 1997. COPAXONE(R)is marketed in the United States by Teva Neuroscience, based in Kansas City, Mo., a subsidiary of Teva Pharmaceutical Industries, Ltd.

For more information about multiple sclerosis call Shared Solutions(TM) at 1-800-887-8100.

COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries, Ltd.

Shared Solutions(TM) is a registered trademark of Teva Neuroscience LLC.

For more information about multiple sclerosis call Shared Solutions(TM) at 1-800-887-8100.

Contact: Teva Pharmaceutical Industries Ltd.
  Dr. Aaron Schwartz
  (011) 972-3-926-7277
  Teva Neuroscience LLC.
  Larry Downey
  (816) 966-4753
  Fleishman-Hillard, Inc.
  Holly Gibson
  (816) 512-2349