Athersys, Inc., a clinical stage biotechnology company, has received a SBIR Fast Track grant from the National Heart, Lung, and Blood Institute (NHLBI), which will support a phase II clinical study evaluating the administration of MultiStem therapy to patients who have suffered a heart attack, or acute myocardial infarction (AMI). The grant is expected to provide up to $2.8 million in support over the course of the study in connection with study progress and milestone achievement.
"We are pleased to receive this SBIR award as it will support us in moving our AMI program forward into phase II development," said Dr Anthony Ting, senior director of Cardiovascular and Pulmonary at Athersys. "The phase II clinical study will build on the promising results demonstrated previously in our AMI phase I trial completed in collaboration with the Cleveland Clinic, Columbia University Medical Centre, Henry Ford, and other leading cardiovascular centres, and is intended to establish definitive proof-of-concept. We expect to initiate the study early next year."
In January 2012, Circulation Research published results of Athersys' phase I clinical study, which found that the administration of MultiStem was safe and well tolerated in patients who had recently suffered an AMI and also suggested that MultiStem can help improve heart function. Patients who exhibited significant myocardial damage and received > 50 million cells demonstrated strong trends for improvement in both ejection fraction and left ventricular stroke volume during the follow-up period, which, based on historical results, are believed to correlate with improved clinical outcomes.
Previously published preclinical studies of MultiStem have shown that administration of MultiStem can convey substantial therapeutic benefits through multiple distinct mechanisms, such as protecting and preserving at risk tissue in the heart, reducing inflammation, and promoting revascularization over time. Studies in both rodent and porcine models of AMI have shown meaningful improvements in cardiac function and increased capillary density in the heart.
Acute myocardial infarction is a leading cause of morbidity and mortality worldwide. A myocardial infarction occurs when the blood supply to the heart is interrupted or diminished, leading to ischemic myocardial tissue.
MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop a bone allograft product in the orthopaedic market.
Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life.