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FDA Fast Track Designation for Phase 3 CLI Program, Aastrom Biosciences (ASTM)

ASTM has granted fast track designation for their critical limb ischemia (NYSE:CLI) cell therapy development  program.

ASTM plans to initiate Phase 3 clinical testing of its treatment for CLI in early 2011:

  • The fast track designation may also accelerate the timing of  regulatory submissions to the FDA and expedite FDA review of the marketing application once Phase 3 testing is completed.
  • 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;
  • Fast track-designated drugs and biologics ordinarily qualify for priority review, thereby expediting the review process;
  • In addition, the designation may allow ASTM to submit portions of the Therapeutic Biologic Application on a rolling submission basis.

CLI is the most severe form of peripheral artery disease, leading to over 160,000 major limb amputations per year in the U.S.

  • 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.