The Michael J. Fox Foundation for Parkinson's Research (MJFF) will provide $2.5 million to support Ceregene Inc.'s new Phase 2 study of CERE-120. This novel gene therapy product delivers the gene for neurturin, a potent neurotrophic (growth) factor that has shown potential to improve the status of degenerating neurons in both preclinical and clinical studies. CERE-120 has the potential to improve motor function as well as slow Parkinson's disease (PD) progression. The competitive funding was awarded as part of the MJFF 2010 LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) program on neurotrophic factors.
"Ceregene is enthusiastic about the continued support from The Michael J. Fox Foundation and this award will allow us to enroll the appropriate number of Parkinson's patients to statistically power our upcoming controlled Phase 2 clinical study," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene, Inc. "This funding marks the fourth award from The Michael J. Fox Foundation for Ceregene and we are truly grateful for their support," noted Dr. Ostrove.
The principal investigators of this award are Ceregene's executive vice president and chief scientific officer Raymond T. Bartus, Ph.D. and Joao Siffert, M.D., Ceregene's chief medical officer. "We have made significant progress researching and implementing important refinements to improve the delivery and bioactivity of CERE-120, based on insight gained from our past clinical trials in PD patients. We now look forward to testing these improvements in a controlled clinical trial in PD patients to more clearly establish the safety and improved efficacy of CERE-120," stated Dr. Bartus.
"With the enrollment in the Phase 1 portion of this study complete, we now look forward to initiating the controlled Phase 2 portion. The CERE-120 clinical development continues to receive strong support from leading movement disorder centers and The Michael J. Fox Foundation," said Dr. Siffert.
MJFF funding complements Ceregene's own multi-million dollar investment in the study. Patient enrollment for the new Phase 2 study is expected to begin later this summer at 10 major medical centers throughout the US including: Baylor College of Medicine, Houston, TX; Columbia University Medical Center in New York, NY; Duke University, Durham, NC; Emory University Hospital, Atlanta, GA; Mount Sinai Medical Center New York, NY; University of Alabama at Birmingham, AL; University of California, San Francisco, CA; University of Pennsylvania, Philadelphia, PA; Rush University Medical Center, Chicago, IL and Stanford School of Medicine, Palo Alto, CA.
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