Aastrom Biosciences to re-focus on DCM program, and cut workforce

US cardiovascular drug developer Aastrom Biosciences (NasdaqCM: ASTM) has announced a strategic change in its R&D programs to focus on the clinical development of its lead product, ixmyelocel-T, for the treatment of dilated cardiomyopathy (DCM).

Aastrom, which recently initiated the Phase IIb ixCELL-DCM clinical trial, previously received a US orphan drug designation for the use of ixmyelocel-T in the treatment of DCM. As a result of the strategic change, Aastrom will stop enrollment and end the Phase III REVIVE clinical trial in patients with critical limb ischemia (CLI). In addition, the company is executing a corporate restructuring that will reduce staff and operating expenses by around 50%.

Nick Colangelo, president and chief executive of Aastrom, stated: "We completed our strategic review of the CLI program, including an evaluation of the challenges in enrolling patients in the REVIVE study and a recent determination that the CLI program would not be supported by a partner in a timeframe that would impact the pace of enrollment of the study. Based on this review, we have decided that the best path to commercialization of ixmyelocel-T is to focus aggressively on the DCM program. We will begin treating patients in the Phase IIb ixCELL-DCM clinical study within the next few weeks.”