Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Jun 11 2010

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences (Nasdaq:ASTM), will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery. Dr. Powell's presentation will include additional results from the interim analysis showing that the trial reached statistical significance on amputation-free survival in patients with critical limb ischemia (CLI), a key criterion used by the FDA to evaluate the effectiveness of investigative treatments for CLI.

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>

Dr. Powell's presentation, entitled "Interim Results from a Randomized, Placebo Controlled, Double-blind Multi-center Phase II Trial Comparing Expanded Autologous Bone Marrow in Patients with Critical Limb Ischemia," will provide additional clinical detail on the full RESTORE-CLI interim dataset.