Aastrom seeks SPA for Phase 3 trial Print E-mail
By Staff and Wire Reports   
Wednesday, 20 October 2010 10:44

Aastrom Biosciences, Inc. (Nasdaq:ASTM) which is developing expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, announced today that they submitted to the FDA a special protocol assessment (SPA) describing their 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.  Phase 2b data from their RESTORE-CLI trial are expected in November of this year.

Shares traded up as high as $1.57 on the news, but have settled to $1.54 +0.01 (0.65%) as of this report. This news comes days after the company announced their cell therapy treatment had received Fast Track designation from the FDA.

"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."

Positive interim results were presented in February with an update on progress in June. In February 2010, Aastrom reported top-line results from a planned interim analysis of the multi-center, randomized, double-blind, placebo-controlled RESTORE-CLI clinical trial. Based on a composite efficacy endpoint assessing time to first occurrence of treatment failure (defined as major amputation, all-cause mortality, doubling in wound size and de novo gangrene), treatment with autologous tissue repair cells (TRCs) prepared by Aastrom were shown to be more effective than placebo (P=0.005). Additional results from the RESTORE-CLI interim analysis are being presented today and include the finding that amputation-free survival – defined as time to major amputation or death – was also statistically significant in favor of TRC treatment (P=0.038). 

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.

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.

An SPA is a written agreement between the FDA and a drug sponsor concerning clinical trial design, endpoints and other clinical trial issues that can be used to support regulatory approval of a therapeutic product candidate. The process is intended to increase the likelihood that if the specified clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favorable risk-benefit profile, trial data may serve as the primary basis of an efficacy claim in support of a Biologic License Application (BLA).

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