Phase III Results For Copolymer 1 Disappointing

16 October 1994

Teva's Copaxone (copolymer 1) demonstrated a 24% reduction in relapse rates over two years compared to placebo in relapse-remitting multiple sclerosis patients, according to a presentation of Phase III results in Paris last week by chief investigator Kenneth Johnson, professor and chairman of the department of neurology, University of Maryland School of Medicine.

The double-blind, placebo-controlled, randomized multicenter trial consisted of 281 patients assigned to either 20 mg of copolymer 1 by subcutaneous injection or placebo daily for two years. The primary endpoint was relapse rate, with secondary endpoints of time to first relapse, number of relapse-free patients, number of progression-free patients, time to progression and change in disability.

At baseline, patients in both arms of the study had mean relapse rates of 2.9 per year over the previous two years. The mean Kurtzke Expanded Disability Status Scale (EDSS) was 2.8 in the copolymer group and 2.4 in the placebo group. The mean ambulation index was 1.2 and 1.1 respectively.

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