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Ceregene Reports Additional Efficacy Data From Parkinson's Disease Phase 2b Study
Date:5/21/2013

SAN DIEGO, May 21, 2013 /PRNewswire/ -- Ceregene, Inc. today announced additional efficacy data from a secondary analysis of its double-blind, randomized, controlled Phase 2b clinical study of CERE-120 (AAV-neurturin). CERE-120 is a gene therapy product designed to deliver the neurotrophic factor neurturin, for Parkinson's disease.  This exploratory analysis identified a more robust response to CERE-120 in Parkinson's patients diagnosed within 5 years prior to treatment relative to those diagnosed 10 years or more (p<.005), as measured by change from baseline on the Unified Parkinson's Disease Rating Scale or (UPDRS) motor-off, the primary endpoint for this study. Previously Ceregene reported that the primary endpoint (UPDRS) was not met for the overall study population, although one of the 3 prescribed 'key secondary endpoints' (Diary-hours off) did demonstrate statistical significance and no safety issues were identified.  In addition to CERE-120 favorably impacting the UPDRS motor-off scale in patients treated within 5 years of diagnosis, additional exploratory analyses revealed similar improvement for the same patients in other important Parkinson's disease measurements, including the PDQ-39 (a measure of quality of life) and patient's daily diaries (computing hours "on without troubling dyskinesias").

Raymond T. Bartus , Ph.D., executive vice president and chief scientific officer of Ceregene stated: "The concept that earlier-stage patients may respond better to neurotrophic factor therapies such as CERE-120 is consistent with the field's long-standing appreciation for their mechanism of action, as well as more recent information derived from autopsy brain tissue donated by Parkinson's disease patients. While a number of practical considerations will have to be addressed in order to design and execute clinical trials that enroll only early-stage patients, this additional exploratory
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SOURCE Ceregene, Inc.
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