Aastrom Biosciences, Inc. (Nasdaq:ASTM) is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial in patients with ischemic dilated cardiomyopathy. The Company announced that it has enrolled its first patient in the REVIVE Phase 3 clinical trial of ixmyelocel-T. The REVIVE study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of no option patients with critical limb ischemia (CLI).
The REVIVE trial is "the largest randomized, double-blind, placebo-controlled, multicenter study ever conducted in patients with CLI. The Phase 3 trial has 80 treatment centers qualified to enroll patients and will include 594 CLI patients who have no option for revascularization and also have existing tissue loss due to ischemia. Patients will be followed for a total of 18 months, including 12 months from randomization for efficacy and an additional six months for safety. The primary endpoint of the trial will be amputation-free survival at 12 months."
Tim Mayleben, president and chief executive officer at Aastrom Biosciences, commented,
"The enrollment of the first patient in the REVIVE clinical trial represents another important milestone in our effort to advance the development program for ixmyelocel-T through the final stages of clinical development. We are grateful to our investigators for their commitment to enrolling patients as quickly as possible in this important trial."