An SPA is a written agreement between the FDA and a drug sponsor (ASTM)concerning clinical trial design, endpoints and other clinical trial issues that can be used to support regulatory approval of a therapeutic product candidate. The process is intended to increase the likelihood that if the specified clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favorable risk-benefit profile, trial data may serve as the primary basis of an efficacy claim in support of a Biologic License Application (BLA).
ASTM is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program. In 6/10, results from a planned interim analysis of the ongoing Phase 2b RESTORE-CLI clinical trial were announced at the Society for Vascular Surgery annual meeting. Included in the results was the achievement of statistical significance on amputation-free survival (P=0.038), defined as time to major amputation or death.
Critical limb ischemia (CLI), the most severe form of peripheral vascular disease, leads to over 160,000 major limb amputations per year in the U.S. Data suggests that approximately 20%of patients will die within the first 6-12 months of CLI onset. Current therapeutic options are limited and often ineffective for the most severely affected patients.
More SPA More information is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571