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Ceregene Initiates a New Controlled Phase 2b Trial of CERE-120 for Parkinson's Disease
Date:10/19/2010

search (www.michaeljfox.org).

"We are proud to play a key role in this potentially high-impact project," said Todd Sherer, Ph.D., vice president of research programs at The Michael J. Fox Foundation. "The Foundation continues to believe that trophic factors hold enormous potential to become transformative therapeutics for people with Parkinson's."

The first Phase 2 clinical trial of CERE-120, completed in November 2008, did not meet its pre-designated primary endpoint (Unified Parkinson's Disease Rating Scale- Motor Off at 12 months) although a clinically modest benefit was seen in improving motor performance and quality of life in Parkinson's disease patients, based on statistically significant differences in several secondary endpoints. Even greater improvement was seen following an analysis of all patients who were assessed under blinded conditions at 15 to 18 months post-treatment, including on the primary measure (UPDRS motor off at 18 months, p=0.025). Importantly, new scientific insight regarding degenerating dopamine neurons in the brains of advanced Parkinson's disease patients was gained from CERE-120-treated patients who died of unrelated causes, combined with the clinical results, led to important changes in CERE-120 dosing intended to significantly enhance its bioactivity and response to treatment. This revised dosing paradigm now targets both the terminals (or nerve endings) of the degenerating neurons in a site in the brain called the putamen, as well as the cell bodies of these neurons, located in another brain region called the substantia nigra.

"We are pleased to initiate a new controlled Phase 2b study that is statistically powered to demonstrate the efficacy of CERE-120," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We continue to strongly believe that CERE-120 has the potential to improve the symptoms of Parkinson's disease while also delaying
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SOURCE Ceregene, Inc.
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