Athersys, Inc. (Nasdaq:ATHX) announced today positive results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. The study results, based on four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients.
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. Enrolled patients received MultiStem delivered via a catheter into the damaged region of the heart 2-5 days following percutaneous coronary intervention (PCI), a standard treatment for heart attack. The study includes patients in three treatment cohorts or dose groups (20 million, 50 million and 100 million cells per patient) and a registry group where patients received only standard of care. Nineteen treated and six registry subjects participated in the study. The trial is being conducted at cardiovascular treatment centers in the United States, including the Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System.
Highlights of the Study:
- Administration of MultiStem was found to be well tolerated at all dose levels
- No clinically significant changes in vital signs, allergic reactions, or infusion-related toxicities were associated with MultiStem administration
- Each dose group showed improvement in mean left ventricular ejection fraction (LVEF), a measure of heart function, compared to baseline and relative to the registry group
- Patients in the 50 million dose group had a statistically significant absolute improvement in mean 4-month LVEF relative to baseline (9.8 percentage points, representing a 23.4% improvement over baseline, p<0.02)
- Among patients with more severe heart attacks – as measured by baseline LVEFs less than or equal to 45% – the 50 and 100 million dose groups each demonstrated better than a 25% improvement in mean LVEF at 4 months post treatment over baseline
"We are encouraged by the results of this phase I study, and based on these results, will work with our partner, Angiotech Pharmaceuticals, on plans for a phase II trial to further evaluate safety and assess improvement in cardiac function" said Gil Van Bokkelen, CEO of Athersys, Inc. "This study is an important step and provides additional validation of the clinical potential and therapeutic profile of MultiStem as an off-the-shelf, allogeneic stem cell therapy, and we look forward to building off these results."
Dr. Marc Penn, M.D., Ph.D., co-principal investigator of this study and Director of Cardiovascular Cell Therapy at the Cleveland Clinic, and Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics, plans to present additional data and results and further discuss the study on September 22, 2010 in Washington, D.C. at the Symposium "Strategies for Cardiovascular Repair: Stem Cell Therapy and Beyond," at the Transvascular Cardiovascular Therapeutics Conference.
"These phase I results suggest that MultiStem is well tolerated when administered to the damaged region of the heart following a heart attack," said Dr. Penn. "MultiStem's safety profile, together with trends suggesting meaningful improvement in functional measures, illustrates the potential of this therapy in this area and supports further clinical study of MultiStem for the treatment of heart disease."
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