January 25, 2010

The goal of this Phase II Clinical Trial is to evaluate the effectiveness and safety of Prochymal® for preventing and treating heart damage resulting from a heart attack. It will study the therapy’s ability to improve heart function, limit scar formation and preserve functional heart tissue following a patient’s first heart attack. The therapy must be administered within seven days after a patient’s first heart attack. In an initial Phase 1 cardiac trial involving 53 patients, adverse events were lower, heart function improved and cardiac arrhythmias (irregular heartbeat) were reduced in patients treated with Prochymal compared to the placebo group.

“Stem cells represent a promising cardiac research avenue, given their potential to restore heart function in at-risk patients,” said Howard J. Eisen, M.D., chief of the Division of Cardiology at Drexel University College of Medicine and Hahnemann University Hospital and principal investigator for the Drexel study site. “Cardiologists today are unable to reverse cardiac deterioration following a severe heart attack. If stem cells can effectively prevent or repair heart muscle damage, there is potential to meaningfully reduce long-term complications such as repeat heart attacks and heart failure.”

A heart attack occurs when blood flow is suddenly and completely blocked. More than half a million Americans will have their first heart attack this year. According to the American Heart Association, within six years of a recognized heart attack, 18 percent of men and 35 percent of women will have a repeat heart attack. Additionally, a heart attack can significantly weaken heart muscle, which limits the patient’s ability to pump blood throughout the body and may ultimately lead to chronic heart failure.

This double-blind, placebo-controlled stem cell study will enroll approximately 220 patients at 40 centers in the United States and Canada.