CLEVELAND—Athersys Inc. recently announced thatit has received a SBIR Fast Track grant from the National Heart, Lung, andBlood Institute, which will support a Phase II clinical study evaluating theadministration of its MultiStem therapy to patients who have suffered aheart attack, or acute myocardial infarction (AMI).
The grant is expected toprovide as much as $2.8 million in support over the course of the study inconnection with study progress and milestone achievement.
"Weare pleased to receive this SBIR award as it will support us in moving our AMIprogram forward into Phase II development," said Dr. Anthony Ting, senior director of cardiovascular and pulmonary at Athersys. "The Phase IIclinical study will build on the promising results demonstrated previously inour AMI Phase I trial completed in collaboration with the Cleveland Clinic,Columbia University Medical Center, Henry Ford, and other leadingcardiovascular centers, and is intended to establish definitiveproof-of-concept. We expect to initiate the study early next year."
InJanuary 2012, Circulation Research published results of Athersys' Phase I clinical study, which found that the administration of MultiStem was safe andwell tolerated in patients who had recently suffered an AMI and also suggestedthat MultiStem can help improve heart function.
MultiStem cell therapy is a patented regenerativemedicine product that has shown the ability to promote tissue repair andhealing in a variety of ways, the company says, such as through the production of multipletherapeutic factors produced in response to signals of inflammation and tissuedamage. MultiStem has reportedly demonstrated therapeutic potential for the treatment ofinflammatory and immune disorders, neurological conditions, and cardiovasculardisease, as well as other areas, and represents what the company calls "a unique 'off-the-shelf' stem-cell product that can be manufactured in ascalable manner, may be stored for years in frozen form, and is administeredwithout tissue matching or the need for immune suppression."