Ceregene Receives Additional Grant from Michael J. Fox Foundation
News Aug 06, 2009
Ceregene, Inc. has announced that the Michael J. Fox Foundation will provide partial funds for long-term follow-up testing of patients enrolled in the company's Phase 2 trial of CERE-120 for Parkinson's disease.
The funding will enable Ceregene to collect and analyze more extensive data for up to 48 months from patients with advanced Parkinson's disease who were enrolled in the double-blind, controlled trial which ended in November 2008.
As was previously announced, the Phase 2 trial of CERE-120 involving 52 patients, failed to demonstrate a difference in the primary endpoint between patients in the CERE-120 versus control group. It was subsequently announced, however, that CERE-120 suggested improvement on several secondary endpoints at 12 months, and at 18 months, a statistically significant treatment effect on the primary endpoint emerged, while several additional secondary endpoints also showed improvement.
In contrast, on no measure did sham patients perform better than CERE-120 patients, at either 12 or 18 months. Based on those findings, and insight gained from analyses of post-mortem brain tissue from two CERE-120 treated patients, the company has revised the dosing regimen and expects to initiate a new trial of CERE-120 in the near future.
"We are pleased to be able to gather unique, long-term data from both CERE-120 treated and control patients and thus gain more information about the potential long-term effects of CERE-120 on Parkinson's disease," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.
"We very much appreciate the support the MJFF has provided to enable us to expand the testing of these patients and further enrich our data base. Our conviction about CERE-120's potential to treat Parkinson's disease remains strong. We learned a significant amount from the initial Phase 2 trial which enabled us to design a protocol that should maximize the potential for the greatest treatment effect in our upcoming Phase 2 trial."