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SEATTLE, Oct. 13 /PRNewswire/ -- Results from the first head-to-head study to compare the effect of the three FDA-approved therapies on relapse rate in relapsing-remitting multiple sclerosis were presented today at the American

Neurological Association conference in Seattle.

Dr. Omar Khan, director, experimental therapeutics and research, at Wayne State University MS Center, reported that, compared to patients on no therapy,

COPAXONE(R) and Betaseron(R) significantly reduced relapses in patients with relapsing-remitting multiple sclerosis, while patients on Avonex(R) failed to show a statistically significant therapeutic effect in this 12-month treatment study.

  "The results are significant because this study compares the drug therapies and the choice of no therapy in a real-life situation," said Dr. Khan.  "We presented patients with information on all treatment options, after which they chose a therapy.  Then, we evaluated whether the drugs reduced relapses during a prospective 12-month period."

  The study involved 156 patients with relapsing-remitting multiple sclerosis.  Study physicians evaluated the two-year history of relapses for each patient to determine the relapse rate prior to the initiation of therapy. Then, patients were presented with information on the three therapies approved for relapsing-remitting multiple sclerosis.  The patients could choose any one of the drugs or no therapy.

Patients were divided evenly among the drug therapies, with 40 choosing Avonex(R), 41 selecting Betaseron(R) and 42 deciding on COPAXONE(R). Thirty-three patients elected no treatment.  Each group had similar age, relapse rate, neurologic examination and Expanded Disability Status Scale (EDSS) ratings prior to initiating therapy.

Patients entering the study had a relatively low average disability (EDSS) rating, which means that most participants had few noticeable physical symptoms.

Last fall, the National Multiple Sclerosis Society recommended that all people with a confirmed diagnosis of relapsing-remitting MS discuss immediate therapy with their doctor.

 "These results support the rationale behind early initiation of treatment in patients with relapsing-remitting MS," said Dr. Khan.  "Even in a relatively early stage of the disease, patients on Betaseron(R) or COPAXONE(R) showed a benefit over those patients who chose no treatment."

Evaluation of the patients' disability progression was a secondary study measurement.  Researchers conducted a disability assessment at the beginning of the study to determine each patient's EDSS score.  This rating system measures a patient's ability to function physically through a series of tests based on strength, coordination, manual dexterity and other measure of neurologic function.

  "Compared to patients on no treatment, there was a statistically significant improvement in disability scores in patients who received treatment with Betaseron(R) or COPAXONE(R).  Patients who received treatment with Avonex(R) did not show any significant improvement during the 12-month period," said Dr. Khan.

  This study comes closer to approximating what neurologists see in clinical practice because it was not blinded.  In a non-blinded and non-randomized study, both the study participants and the researchers know which drug the patients are taking.  However, the results from this study are similar to those results previously reported in randomized, placebo-controlled Phase III studies.

  For more information about MS drug therapies, contact Wayne State University MS Center at 313-966-9407

This study was supported by the Wayne State University Neuroscience Program. Comparison Study for Multiple Sclerosis

FACT SHEET 

  -- The first head-to head study comparing the effect of three approved therapies for relapsing-remitting multiple sclerosis (RRMS) supports early initiation of treatment in patients with RRMS. 

  -- The trial is the first to compare the three drug therapies and the choice of no therapy. 

  -- Results from the prospective, controlled, and open-label treatment trial were that therapy with COPAXONE(R) and Betaseron(R) significantly reduced relapses in patients with RRMS, while treatment with Avonex(R) failed to show a statistically significant therapeutic effect. 

  -- The study also showed treatment with COPAXONE(R) and Betaseron(R)  showed a significant reduction in EDSS (Expanded Disability Status Scale) compared to the untreated group after 12 months of therapy.  However, treatment with Avonex(R) did not result in a reduction in EDSS.  EDSS is one of the oldest and most universally used rating  systems for judging the clinical status of people with MS. 

  -- Treatment with COPAXONE(R) alone had a highly significant effect during the second half of the 12-month treatment period, supporting recent data regarding the mechanism of action of COPAXONE(R) that suggests a delayed and sustained therapeutic effect. 

  -- Dr. Omar Khan, director, experimental therapeutics and research, Wayne State University MS Center, reported the results at the American Neurology Association's conference held October 9-13 in Seattle.  The three-year study, supported by Wayne State University's Neuroscience  Program, involved 156 patients with RRMS. 

  -- Between August 1996 and September 1999, 156 consecutive patients with clinical definite RRMS prior to initiating immunomodulating therapy  were invited to participate in the study.  Patients elected to receive  the therapy of their choice.  Patients were divided evenly among the drug therapies, with 40 choosing Avonex(R), 41 selecting Betaseron(R) and 42 deciding on COPAXONE(R).  Thirty-three patients elected no treatment.  Each group had similar age and disability ratings. 

  -- This study was non-randomized and non-blinded. Both the study participants and researchers knew which drug the patients were taking. However, the results from the trial are similar to those results observed in randomized, placebo-controlled Phase III studies. 

  -- Betaseron(R) (interferon Beta 1b) is a high dose IFN-beta interferon  for use in patients with relapsing-remitting multiple sclerosis.  Betaseron(R) is taken every other day by subcutaneous injection and is manufactured by Berlex Laboratories, Inc. 

  -- Avonex(R) (interferon beta-1a) is produced in cells from mammals using recombinant DNA technology and is taken once a week by intramuscular  injection.  Avonex(R) is marketed by Biogen, Inc. 

  -- COPAXONE(R) (glatiramer acetate for injection) is a non-interferon, nonsteroidal agent.  COPAXONE(R) is administered daily by subcutaneous  injection.  It is manufactured by Teva Pharmaceutical Industries, Ltd.  It is marketed in the United States by Teva Marion Partners, a partnership established between Teva and Hoechst Marion Roussel, Inc. 

  -- In 1998 the National Multiple Sclerosis Society recommended that all people with a confirmed diagnosis of RRMS discuss immediate therapy with their doctor.  The study results support the rationale behind early initiation of treatment in patients with RRMS. 

For more information, call Janell Aust or Wendy Maris, both of Fleishman-Hillard Inc. at 816-474-9407. /Contact:  Janell Aust or Wendy Maris, both of Fleishman-Hillard Inc.,816-474-9407, for Wayne State University/