Ceregene, Inc., a biopharmaceutical company, has reported clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease.
The trial did not demonstrate an appreciable difference between patients treated with CERE-120 versus those in the control group. Both groups showed an approximate 7 point improvement in the protocol-defined primary endpoint (Unified Parkinson's Disease Rating Scale- motor off score at 12 months), relative to a mean at baseline of approximately 39 points. Both groups had a substantial number of patients who demonstrated a meaningful clinical improvement from baseline. CERE-120 appeared to be safe and well tolerated.
"On behalf of everyone at Ceregene, I would like to personally express my gratitude to all the patients, physicians and staff who participated in this study. We share their disappointment. We also offer our heartfelt appreciation to the many talented and dedicated employees at Ceregene who continue to work extremely hard on this and Ceregene's other programs," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We continue to believe in the multiple opportunities in our pipeline that target a range of serious neurodegenerative and ocular diseases."
"The medical research community has for several decades attempted to use the unique healing properties of neurotrophic factors to treat serious neurodegenerative diseases, and Ceregene's use of gene therapy as an essential enabling technology to translate this idea into an effective human therapeutic has consistently generated strong empirical support," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer. "Thus, we are stunned by the results of this trial and will continue to analyze the data in order to gain greater insight into the factors that may have contributed to this negative outcome, not only to build upon this insight for our Parkinson's program, but also to help assure continued successful development of our product candidates for other diseases."