Ceregene Initiates a New Controlled Phase 2b Trial of CERE-120 for Parkinson's Disease
SAN DIEGO, Oct. 19 /PRNewswire/ -- Ceregene, Inc., a biopharmaceutical company, announced today that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).
The launch of Phase 2 follows a fully enrolled Phase 1 portion that demonstrated early safety using an enhanced CERE-120 dosing regimen targeting the substantia nigra and putamen, two brain areas especially affected by Parkinson's disease. This study is enrolling at 11 major medical centers throughout the United States and includes investigators Drs. Mark Stacy and Dennis Turner at Duke University School of Medicine, Drs. Catherine Cho and Ron Alterman at Mount Sinai Medical Center, New York, and Drs. Stewart Factor and Nicholas Boulis at Emory University Hospital, who were all involved in treating the patients in the Phase 1 portion of this study.
Additional clinical sites include Columbia University Medical Center, NYC, NY; Beth Israel Medical Center, NYC, NY; University of Pennsylvania Hospital, Philadelphia, PA; University of Alabama, Birmingham, AL; Rush University Medical Center, Chicago, IL; Baylor College of Medicine, Houston, TX; University of California, San Francisco, CA and Stanford University School of Medicine, Palo Alto, CA.
This Phase 2b clinical study is partially funded by a $2.5M LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) award from The Michael J. Fox Foundation for Parkinson's Re