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Aastrom Biosciences Inc. (ASTM), FDA Reach Protocol Agreement for Phase 3 Clinical Trial of Multicellular Therapy

Aastrom Biosciences Inc., leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the Special Protocol Assessment (SPA) for the design of the company’s phase 3 REVIVE-CLI clinical trial of ixmyelocel-T.

Ixmyelocel-T is the company’s expanded multicellular therapy, designed to treat patients with critical limb ischemia (CLI) who have no other treatment options. CLI leads to more than 160,000 limb amputations each year in the United States, making it the most severe form of peripheral artery disease. CLI is also fatal; approximately 25 percent of patients diagnosed with CLI will die within the 12 months of diagnosis, while fewer than 25 percent of patients survive more than four years following diagnosis.

Aastrom’s will enroll up to 594 no-option patients at approximately 80 clinical sites across the U.S. This phase 3 clinical trial will be a randomized, double-blind, placebo-controlled study that will include only CLI patients with existing tissue loss, such as ulcerations and gangrene.

“We greatly appreciate the guidance and support of the FDA staff, our phase 2 investigators and our phase 3 steering committee who have helped us reach final agreement on the SPA, a critical component to advancing ixmyelocel-T into phase 3 clinical testing,” Tim Mayleben, president and CEO of Aastrom stated in the press release.

Mayleben said the SPA confirms the company’s confidence that the design of the phase 3 trial, also supported by positive results from the previously conducted RESTORE-CLI phase 2b trial, which was the largest fully controlled cell-therapy study ever conducted in CLI, in patients who received treatment with ixmyelocel-T.

The therapy demonstrated a favorable safety profile and clinically meaningful and statistically significant benefit in time to treatment failure events. Aastrom will present the data for the phase 2b trial at a major medical meeting in November.

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