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 months per patient, and shows no serious adverse events (SAEs) in any of the six subjects dosed, including no effect on weight. All patients were discharged from the hospital within 48 hours of surgery, as planned. Consistent with the safety profile observed in the Phase 1 trial, no CERE-120-related serious adverse events have been observed in the ongoing Phase 2 trial. In total, approximately 60 subjects with Parkinson's disease have now been treated with CERE-120 across four studies (several as long as five years ago) of which approximately 10 received the new dosing paradigm targeting the substantia nigra.
"It is encouraging that CERE-120 continues to appear safe and that the new dosing paradigm we implemented seems well-tolerated," stated Joao Siffert, M.D., Ceregene's vice president, chief medical officer.
The current Phase 2b trial is designed to test whether CERE-120, when delivered to the degenerating neuronal cell bodies (in the substantia nigra) as well as the terminals of these neurons (in the putamen) can restore sufficient function to produce meaningful clinical benefit. This improved dosing paradigm is based on insight gained from a prior CERE-120 Phase 2 clinical trial in Parkinson's disease patients (Marks et al, Lancet Neurology, 2010; Bartus et al, Movement Disorders, 2010) and is intended to enhance and accelerate the response to CERE-120 previously observed.
"We are pleased and encouraged by our continued progress developing CERE-120 for Parkinson's disease and look forward to eventually determining how much more effective this new dosing paradigm might be for people with Parkinson's disease," stated Raymond Bartus, Ph.D., executive vice president and chief scientific officer of Ceregene.
The trial is partially funded through a competitive grant to Ceregene from the Michael J. Fox Foundations' 2010 LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) program on neurotrophic factors.
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