Aastrom Biosciences (NASDAQ: ASTM) announced that final results from the company's RESTORE-CLI Phase IIb clinical trial for ixmyelocel-T were published in the peer-reviewed journal MolecularTherapy. The Phase IIb clinical results demonstrated that treatment with ixmyelocel-T improved time to treatment failure in patients with critical limb ischemia (CLI) compared to the control group, and in the subgroup of patients with wounds at baseline demonstrated an improvement in amputation free survival. A total of 48 patients were treated with ixmyelocel-T and 24 received a placebo. Adverse event rates in both groups were similar. Patients in the treatment arm showed a 62% reduction in risk relative to placebo in the primary efficacy endpoint of time to first occurrence of treatment failure. A post hoc analysis of the subgroup of 45 patients with wounds at baseline resulted in a 77% risk reduction in time to first occurrence of treatment failure and a positive trend in the Phase III endpoint of amputation-free survival.
Daily Dose Take-Away: This data clearly suggests that ixmyelocel-T (expanded bone marrow) is active and impact the course of the disease. The Phase 3 trial is now funded and well powered. While its been a long road, Aastrom fundamentals are moving in the right direction.
