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Athersys Receives Fast Track Grant for Development of MultiStem in Heart Attack Patients
Published Tuesday, August 13, 2013 by Andrew Klips
Although some heart disease rates are on a modest decline in recent years, the indication still represents one of the most grossly underserved areas of medical need in our country.  The most recent statistics from the Centers for Disease Control and Prevention shows that about 600,000 Americans die each year of heart disease, equating to 25 percent of all deaths.  Approximately 715,000 Americans suffer a heart attack each year with associated costs of heart disease tallying a whopping $108.9 billion annually, and with other forms of heart disease the impact exceeds $270 billion annually, according to the American Heart Association (AHA).  Furthermore, due to an aging population the AHA projects that over the twenty year period from 2010 to 2030, the economic impact of heart disease will more than triple, resulting in nearly $820 billion in direct costs annually, and over $1 trillion in direct and indirect costs combined.

The fact is that acute myocardial infarctions (AMI), or heart attacks as they’re more commonly known, damage the heart.  The damage is largely irreparable, making the regenerative medicine arena particularly appealing as a market opportunity for the future of treating heart attack patients.  Two leaders in the space include Mesoblast, Inc. (ASX: MSB) and Athersys, Inc. (NASDAQ: ATHX).  Mesoblast is preparing to launch a 1,700 patient Phase III clinical trial with partner Teva Pharmaceutical Industries Ltd (NYSE: TEVA), using human mesenchymal stem cell therapy to treat congestive heart failure.  Athersys, who has several mid-stage clinical trials ongoing with its allogeneic MultiStem therapy for various indications, including as part of a partnership with Pfizer for Inflammatory Bowel Disease, received some promising news last week for advancing MultiStem to mid-stage trials for heart attack patients.  The company said that it has received a SBIR Fast Track grant from the National Heart, Lung, and Blood Institute to support a Phase 2 clinical trial in AMI patients, which could provide up to $2.8 million to the company over the course of the study.  The company is also currently running a Phase 2 clinical trial in patients that have suffered an ischemic stroke, which represents a huge area of need, and a multibillion market opportunity.

Phase I research provided promising data regarding safety and tolerability of MultiStem in AMI patients while suggesting that the therapy can improve heart function.  Phase II research will seek to further validate efficacious effects and could provide an additional boon to the value of Athersys, which still is far lower than peer Osiris.  Interested parties are encouraged to read the complete press release and learn more about Athersys at:  http://ir.athersys.com/.

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