Aastrom submits SPA for Phase 3 clinical development program in critical limb ischemia to FDA

Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a special protocol assessment (SPA) describing the company's proposed Phase 3 clinical development program in critical limb ischemia (CLI). If the FDA concurs with the protocols outlined in the SPA, Aastrom expects to initiate the Phase 3 program in early 2011.

"We are pleased to have reached this important milestone for our CLI program and our plans for the Phase 3 pivotal clinical program remain on track," said Tim Mayleben, president and CEO of Aastrom. "Proceeding through the FDA's SPA process will help ensure consensus with FDA on trial design and endpoints, and will provide a clear and objective path forward as we advance our first-of-a-kind therapy for severely ill CLI patients."

CLI is the most severe form of peripheral artery disease, leading to over 160,000 major limb amputations per year in the U.S. Approximately 25% of patients will die within the 6-12 months following diagnosis, and less than 25% of patients survive four years. Therapeutic and surgical options are limited and often ineffective for the most severely affected patients.

Earlier this week, Aastrom announced that the FDA has granted fast track designation for the company's CLI program. The FDA's fast track program is designed to facilitate the development and expedite the review of new drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.