Athersys completes enrollment in phase I MultiStem allogeneic stem cell therapy clinical trial

Feb 17 2010

Athersys, Inc. (Nasdaq:ATHX) and Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) announced that Athersys has completed patient enrollment for its phase I clinical trial of MultiStem(R), its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced midyear, upon completion of the four-month patient follow-up visits and analysis of results.

Angiotech and Athersys entered into an agreement in May 2006 to co-develop and commercialize MultiStem(R), Athersys' non-embryonic stem cell platform technology, for use in the indications of AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns marketing and commercial rights with respect to this product candidate.

"Myocardial infarction remains one of the leading causes of death and disability in the United States," said William Hunter M.D., President and CEO of Angiotech. "We believe the data reported to date and the completion of Phase I enrollment in this program affirms the value of our partnership with Athersys, and we are looking forward to working with Athersys to formulate the next clinical development steps for this important product candidate."

The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single administration of allogeneic MultiStem cells following an AMI. Following standard treatment, enrolled patients receive MultiStem delivered via a catheter that enables rapid and efficient delivery of MultiStem into the damaged region of the heart. The study is being conducted at multiple cardiovascular treatment centers in the United States, including the Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System, and includes patients in three treatment cohorts or dose groups, as well as a non-treated registry group.

In preclinical studies conducted by Athersys and independent cardiovascular research teams, administration of MultiStem following an ischemic injury to the heart has been associated with a number of benefits, including an increase in ejection fraction, or volume of blood pumped from the heart, a reduction of inflammation in the region of ischemic injury and increased angiogenesis, each believed to help augment recovery and healing.