Athersys and Angiotech Announce Authorization of Phase I Intramyocardial Stem Cell U.S. Clinical Trial in Acute Myocardial Infarction
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CLEVELAND, OH and VANCOUVER, Dec. 20 - Athersys, Inc. (NASDAQ:ATHX) and Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPI)(NASDAQ:TSX: ANP), announced today that Athersys has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial evaluating the safety of MultiStem® in the treatment of acute myocardial infarction (AMI). The companies believe that this represents the first clinical study of a scalable, allogeneic cell product injected directly into and around the zone of myocardial injury from an intra-coronary approach. This approach is designed to provide the clinician with a readily usable, "off-the-shelf" cell therapy that combines the benefits of efficient, localized delivery and enhanced cell retention in the area of greatest need.
Angiotech and Athersys entered into an agreement in May 2006 to co-develop and commercialize MultiStem®, Athersys' non-embryonic stem cell platform technology, for use in the indications of AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns marketing and commercial rights with respect to this product candidate.
"Stem cell therapy offers the promise of restoring the functionality of damaged heart tissue, helping patients return to a more normal lifestyle following serious heart attacks. We believe that the MultiStem® technology has demonstrated significant promise in the preclinical setting and has the potential to be an effective "off-the-shelf" cell therapy product for the interventional cardiologist," commented Dr. Jeff Walker, Senior VP, Research and Development for Angiotech.
"Building on the success of TAXUS® in revolutionizing stenting, we are committed to and excited about the co-development of MultiStem®," commented Dr. William Hunter, President and CEO of Angiotech. "2008 brings a wealth of opportunity for Angiotech, with the potential regulatory approvals of our 5-FU CVC in the U.S. and our Vascular Wrap(TM) product in Europe, and with MultiStem®, the next generation of therapeutics in interventional cardiology, entering the clinic."
The Phase I study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem® following an AMI. Following standard treatment, enrolled patients will receive MultiStem® delivered via a microinfusion catheter, and these patients will be evaluated and compared to patients receiving standard-of-care only.
Athersys and Angiotech have both evaluated the safety profile of MultiStem®, as well as this product candidate's potential to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on the Athersys preclinical work, the companies believe that MultiStem® can be administered safely and that it may provide substantial functional benefit to patients suffering severe heart attacks.
About MultiStem®
MultiStem cells are proprietary adult stem cells derived from bone marrow, which have the demonstrated ability to form a wide range of cell types. MultiStem may work through several mechanisms, but a primary mechanism appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on its apparent ability to be used without tissue matching or immunosuppression and its capacity for large scale production. Based on research conducted by Athersys and its manufacturing partner, Lonza, the company believes that material from a single qualified donor may be used to produce hundreds of thousands or even millions of clinical doses.
About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ:ANPI)(NASDAQ:TSX:)(NASDAQ:ANP), please visit our website at www.angiotech.com.
About Athersys, Inc.
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The company's lead product candidate, ATHX-105, is an oral, selective 5HT2c receptor agonist in Phase I clinical trials for the treatment of obesity. The company is developing other orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE). Athersys is developing MultiStem®, a patented, adult-derived "off the shelf" stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications.
Source: Angiotech Pharmaceuticals, Inc.
CONTACT: Angiotech Contacts: Jodi Regts, Senior Manager, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 221-7930, jregts@angio.com;
Athersys, Inc. Contacts: William (B.J.) Lehmann, J.D., President and Chief Operating Officer, Athersys, Inc., (216) 431-9900, bjlehmann@athersys.com;
Lisa M. Wilson, In-Site Communications, (917) 543-9932, insiteco@ix.netcom.com
