Aastrom's cell therapy granted fast track designation Print E-mail
By Staff and Wire Reports   
Monday, 18 October 2010 12:15

Aastrom Biosciences, Inc. (Nasdaq:ASTM) which is developing expanded autologous cellular therapies for the treatment of severe cardiovascular diseases announced this morning that the U.S. regulators have granted fast track designation for the company's critical limb ischemia (CLI) cell therapy development program. Shares traded up as high as $1.60 on the news, but have settled to $1.51 +0.04 (2.73%) as of this report.

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.

"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 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. 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.

Aastrom plans to initiate Phase 3 clinical testing of its treatment for CLI in early 2011.

Aastrom Biosciences' proprietary cell manufacturing technology enables the production of cellular therapies expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced its cell therapies into late-stage clinical development, including a planned Phase 3 clinical program for the treatment of patients with critical limb ischemia and two ongoing Phase 2 clinical trials in patients with dilated cardiomyopathy.

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