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Ceregene Completes Enrollment of Second Phase 2 Study of CERE-120 for the Treatment of Parkinson's Disease
Date:12/1/2011

to recognize the need to inject CERE-120 directly into the substantia nigra, thus reducing dependency on retrograde transport."  Additionally, because of the safety record thus far established with CERE-120, the current Phase 2b study injected a 4-fold higher CERE-120 dose into the putamen, compared to prior studies.  "These dosing changes are intended to help assure that the entire degenerating neuron is exposed to sufficient neurotrophic factor, stimulating a more robust neurotrophic response, which in turn, should further enhance and accelerate neuronal repair and clinical benefit," continued Dr. Bartus. 

Ceregene's previous Phase 2a clinical study of CERE-120 demonstrated "proof of concept", showing efficacy on a number of secondary clinical motor and quality of endpoints, with no measurement similarly favoring the sham control treatment.  While that study missed the primary endpoint at 12 months post treatment, a statistically significant improvement from CERE-120 was seen on this measure at 15 and 18 months, post treatment (p=0.023).  Moreover, even more secondary endpoints showed benefit at these longer, post-treatment time points.  The current Phase 2b study will analyze patient outcomes following 15 to 24 months post treatment.  The primary endpoint in both Phase 2 trials is the "UPDRS off" score which is a measure of motor function commonly used in clinical trials of Parkinson's disease.  Ceregene expects to report data from the new Phase 2b study near the end of the first quarter of 2013.

This and prior CERE-120 clinical studies were partially supported by a series of generous grants from the Michael J. Fox Foundation for Parkinson's Disease Research.  Participating Medical Centers included The University of California, San Francisco; Emory University; Baylor College of Medicine; Duke University Medical Center; University of Alabama, Birmingham; Stanford University School of Medicine; The Unive
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SOURCE Ceregene, Inc.
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