Aastrom Biosciences, Inc, a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that the US Food & Drug Administration (FDA) has granted fast track designation for the company's critical limb ischemia (CLI) cell therapy development programme. Aastrom plans to initiate phase-3 clinical testing of its treatment for CLI in early 2011.
"Fast track designation is an important step for our CLI program and underscores the importance of finding an effective treatment option for this devastating disease," said Tim Mayleben, president and CEO of Aastrom. "It may also accelerate the timing of our regulatory submissions to the FDA and expedite FDA review of our marketing application once phase-3 testing is completed. We greatly appreciate the FDA's support of this important clinical programme."
The FDA's fast track programme 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 Aastrom 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 US. Approximately 25% of patients will die within the six to 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.
Aastrom Biosciences is developing expanded autologous cellular therapies for the treatment of severe cardiovascular diseases.