Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today announced positive data for the GALA Phase III clinical trial of high dosage Copaxone for the treatment of multiple sclerosis. The study found that 40 milligram dosages administered three times a week significantly reduced disease activity, and had a favorable safety and tolerability profile. At present a 20 milligram dosage of Copaxone is injected daily.
Teva said that in the Glatiramer Acetate Low-Frequency Administration (GALA) trial, which is a one-year randomized, double-blind, placebo controlled study, GA 40 mg/1 ml significantly reduced annualized relapse rates (ARR) by 34.4% versus placebo. Glatiramer Acetate (GA) is the therapeutic agent in Copaxone (GA injection), which is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS).
In addition, a 34.4% reduction in the cumulative number of new and enlarging T2 lesions and a 44.8% reduction in the cumulative number of gadolinium-enhancing (GdE) lesions was also observed in patients treated with GA 40 mg/1 ml versus placebo. At 12 months, there was no significant difference in the percentage change of brain volume between GA and placebo patients. Teva found that discontinuation rates among the GA and placebo patients was comparable.
The overall frequency of adverse events was comparable to those observed in the placebo group. The most commonly reported adverse events were injection site reactions, headaches and nasopharyngitis.
Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, “We are excited about the potential to offer RRMS patients another safe and effective treatment option for this chronic and debilitating disease. The GALA study demonstrates Teva’s ongoing commitment to the research and development of products aimed at meeting the specific needs of the RRMS community.”
Detailed study results will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France during the late-breaking news parallel session on October 13, 2012.
Published by Globes [online], Israel business news - www.globes-online.com - on October 10, 2012
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