Thursday, June 14, 2012 8:31:29 AM
Teva Pharmaceutical Industries announced positive top-line results from the GALA Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis patients. Study results showed that GA 40 mg/1 ml significantly reduced disease activity, while maintaining a favorable safety and tolerability profile. Results showed that GA 40 mg/1 ml met the study’s primary endpoint by significantly reducing the annualized relapse rate by 34.4 percent compared to placebo. Initial analysis of the data indicates that secondary clinical endpoints were achieved, with the exception of reduction in brain atrophy. Following the initial 12-month, placebo-controlled phase, there will be an ongoing open-label extension of the trial. :theflyonthewall
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