Michael J. Fox Foundation to Fund Continuing Open-Label Study of Cere-120 Safety and Efficacy
“Our Foundation remains hopeful that neurotrophic factors can yield new and better treatments for PD,” said Katie Hood, MJFF CEO. “Extending the observation and analysis of Phase 2 trial enrollees represents a major opportunity to amass new data and learn from patients’ experience.”
The double-blind, controlled clinical trial of CERE-120, which concluded in November 2008, failed to meet its primary endpoint — improved Unified Parkinson’s Disease Rating Scale (UPDRS) motor-off scores after 12 months. However, Ceregene recently reported that an analysis of multiple secondary endpoints suggest modest improvement following CERE-120 and that a revised dosing paradigm will be employed in an additional trial to start later this year. MJFF’s ongoing partnership will allow Ceregene to continue collecting and analyzing data from Phase 2 trial enrollees for another 48 months.
The Michael J. Fox Foundation supported both the Phase 1 and Phase 2 trials of CERE-120 with leadership funding from the family of MJFF Board member Daniel E. Spitzer, MD, and The Pioneer Fund, respectively. The Phase 1 trial in 12 patients demonstrated that CERE-120 was safe and well-tolerated.