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www.fdanews.com/articles/85848-cleveland-clinic-study-finds-benefits-of-high-dose-ms-drug

CLEVELAND CLINIC STUDY FINDS BENEFITS OF HIGH-DOSE MS DRUG

April 6, 2006

A high dose of Israel-based Teva Pharmaceutical's multiple sclerosis (MS) drug Copaxone is more effective at preventing relapses and brain lesions than the standard dose, according to research conducted at the Cleveland Clinic in Cleveland, Ohio.

The 90-patient study found that a 40 mg injection of Copaxone reduced inflammatory disease activity 38 percent more than a 20 mg dose. Rates of side effects, mainly injection site reactions, were unchanged. Relapse rates were reduced by 77 percent, compare to a rate of 62 percent with low-dose Copaxone.

Copaxone is approved to treat relapsing-remitting MS, the most common form of the disease, which causes a progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function.

Teva plans to launch a large-scale Phase III Copaxone study later this year to confirm the findings. The results of that study are expected in 2008, the company said.