Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced completion of patient enrollment for the GALA (Glatiramer Acetate Low-frequency Administration) trial. This international Phase III trial in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to examine the efficacy, safety and tolerability of 40mg COPAXONE® (glatiramer acetate injection) administered three times a week compared to placebo. The primary endpoint of the trial is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase.
Patient enrollment was completed in May 2011, recruiting over 1,400 patients at 180 sites in the United States, Europe, Central Eastern Europe and Israel. Results from the trial are expected in the second quarter of 2012.
"The GALA trial demonstrates Teva's commitment to the continued research and development of COPAXONE®, the global-leading RRMS therapy with 20 years of robust efficacy and safety data," said Professor Yitzhak Peterburg, Teva's Group Vice President, Global Branded Products. "With glatiramer acetate 40mg three times a week, we hope to further enhance the patient experience over the long-term."
The GALA study investigates glatiramer acetate 40mg administered three times a week in comparison to placebo. This dose (glatiramer acetate 40mg) is a higher strength than the currently marketed 20mg of COPAXONE® injected daily.
COPAXONE® is currently approved in over 50 countries worldwide and is indicated for the treatment of RRMS and for patients presenting with clinically isolated syndrome (CIS). It is the worldwide market-leading RRMS treatment with a global market share of 31%.
Teva Pharmaceutical Industries Ltd.