Aastrom Biosciences (Nasdaq: ASTM), a developer of experimental therapies for severe, chronic cardiovascular diseases, announced yesterday that it had achieved positive 12-month final results from a Phase 2 clinical trial testing ixmyelocel-T as a treatment for critical limb ischemia (CLI) patients with no revascularization options.
CLI is a severe form of cardiovascular disease in the legs, known as peripheral artery disease, in which blood vessels get so clogged up that doctors are forced to amputate. Aastrom’s approach involves drawing out a patient’s bone marrow cells, incubating them in a proprietary process at Aastrom’s Ann Arbor facility, and spurring growth of adult stem cells and progenitor cells that promote healing. Those revved up cells get re-infused into the patient, where they are supposed to foster the growth of new blood vessels to improve circulation.
Patients treated with Aastrom’s ixmyelocel-T in the RESTORE-CLI Phase 2 clinical trial showed a 62 percent reduction in the risk of treatment failure, which included outcomes such as amputation, death, increasing wound size, or gangrene, when compared to those given the placebo. It also showed no difference in safety in comparison to the placebo.
“We’re very happy with the results,” said Aastrom CEO Tim Mayleben. “In particular, the safety of our product is very strong. More important to investors and physicians, are the efficacy results, and we feel great about that.”
Mayleben pointed out that the results scored a high P value, which is a statistical term that measures the likelihood that any given finding is due to chance. Aastrom’s results reflect the findings aren’t a matter of chance, Mayleben said.
The results were presented Monday by William Marston, M.D., chief, Division of Vascular Surgery, and professor, Department of Surgery, University of North Carolina, in an oral presentation at the 2011 American Heart Association Scientific Sessions in Orlando, FL.
The RESTORE-CLI Phase 2 clinical trial involved 72 CLI patients treated 18 locations throughout the United States. Patients were randomized, with a two to one treatment vs. placebo ratio. Patients were treated with a one-time course of 20 intra-muscular injections in the lower thigh, calf and foot and were then followed for 12 months.
Mayleben said Aastrom is “weeks away” from initiating the REVIVE-CLI Phase 3 clinical trial for ixmyelocel-T.
“I tell my team internally that we are one of the few companies in biotech that had even made it to a Phase 3,” Mayleben said. “We feel very fortunate.”