Aastrom Biosciences treats final patient in IMPACT-DCM Phase 2 surgical clinical trial

Mar 10 2010

Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported the final patient treatment in the company's ongoing U.S. Phase 2 surgical clinical trial designated IMPACT-DCM. Treated at Emory University Hospital Midtown in Atlanta, GA, this patient received direct injections of Aastrom's tissue repair cells for the treatment of dilated cardiomyopathy (DCM), a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently. With the treatment of the final patient in this trial, Aastrom is positioned to report six-month interim data on all enrolled patients later this year.

IMPACT-DCM is a randomized, controlled, open-label Phase 2 trial which targeted enrollment of 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the U.S. Control patients receive standard medical care, while patients in the treatment arm have received injections of Aastrom's tissue repair cells directly into the wall of the left ventricle in addition to standard medical care. While the primary objective of this trial is to assess safety in patients with DCM, efficacy measures including cardiac dimensions, heart failure stage and other measures of cardiac function are being monitored. Patients are being evaluated at both six months and 12 months following treatment. IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with DCM in both ischemic and non-ischemic patients. This is also the first U.S. Phase 2 cellular therapy trial for heart failure to complete enrollment.

"We are very pleased to announce this important milestone in our cardiac regeneration program," said Tim Mayleben, president and CEO of Aastrom. "We look forward to collecting, analyzing and announcing the data from this first-of-a-kind trial later this year."

Tissue repair cells are produced from a small sample of autologous bone marrow stem cells from each patient. Aastrom's technology significantly expands the natural populations of early stem and progenitor cells for delivery directly to the damaged cardiac tissues of the same patient.