Ceregene Advances Phase 2b CERE-120 (AAV2-neurturin) Trial in Parkinson's Disease
SAN DIEGO, Feb. 3, 2011 /PRNewswire/ -- Ceregene, Inc., a biopharmaceutical company, announced today that it is progressing with enrollment and dosing in its CERE-120 (AAV2-neurturin) Phase 2b multi-center, sham-surgery, double-blinded controlled trial in Parkinson's disease. This trial was initiated in October 2010 and all 11 centers across the United States are now actively enrolling patients. These sites are among the best movement disorders centers in the country and include Baylor College of Medicine (Houston, TX), Beth Israel Medical Center (New York, NY), Columbia University Medical Center (New York, NY), Duke University School of Medicine (Durham, NC), Emory University Hospital (Atlanta, GA), Mount Sinai Medical Center (New York, NY), Rush University Medical Center (Chicago, IL), Stanford University School of Medicine (Palo Alto, CA), University of Alabama (Birmingham, AL), University of California (San Francisco, CA) and University of Pennsylvania Hospital (Philadelphia, PA). To date, approximately 20 percent of the 52 subjects have undergone either CERE-120 administration or sham surgery, with many others enrolled and awaiting surgery. It is anticipated that enrollment will be completed near the end of June 2011.
"We appreciate the enthusiasm and support this trial has received from investigators at the study centers as well as from the Parkinson's community. We look forward to completing enrollment as efficiently and responsibly as possible," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene.
This Phase 2b trial was initiated following the successful dosing of six patients in a Phase 1 safety trial that evaluated, for the first time, the feasibility and safety of targeting the substantia nigra with CERE-120, as well as administering a larger dose than had been tested previously. The Phase 1 safety database currently reflects follow-up periods ranging from seven to 13 mo