Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom 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.

"Our recent discussion with the FDA was very productive and identified a path for pursuing Phase 3 testing of our autologous cell technology in patients with critical limb ischemia," said Tim Mayleben, president and CEO of Aastrom. "We now plan to proceed through the agency's special protocol assessment process which will ensure that we and FDA agree on the Phase 3 clinical program. We appreciate the FDA's thoughtful responses to our questions and their invitation to begin planning for the Phase 3 clinical program through the SPA process."

In June 2010, 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.

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 twenty percent 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.