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The phase I clinical trial is 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 receive MultiStem delivered via a Cricket(tm) Micro-Infusion Catheter, a proprietary device developed and manufactured by Mercator Medsystems (San Leandro, CA). The Cricket catheter enables rapid and efficient delivery of MultiStem into the region of damage in the heart.
Athersys has evaluated the safety and ability of MultiStem to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on this preclinical work, the Company believes that MultiStem may be administered safely and has the potential to improve heart function in patients following severe heart attacks.
William Lehmann, President and Chief Operating Officer at Athersys, commented, "We are excited about the potential of MultiStem to provide benefit in multiple diseases and conditions, and we look forward to providing additional information about this phase I clinical trial and other studies as we move our programs ahead."
Athersys is jointly developing MultiStem for AMI with Angiotech Pharmaceuticals, Inc.
About MultiStem(r)
MultiStem is a proprietary non-embryonic stem cell product that may be derived from bone marrow or other tissue sources, and has the demonstrated ability to form a wide range of cell types. In addition, based on extensive preclinical work conducted by the Company and its collaborators, Athersys believes MultiStem has the potential to deliver benefit through several mechanisms, including the production of multiple therapeutic proteins and factors 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.
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. In addition to its lead product candidate, ATHX-105, the Company is developing other orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders. Athersys is also developing MultiStem(r), 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.
The Athersys, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4548
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the possibility of delays in, adverse results of, and excessive costs of the development process; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Athersys, Inc.
Athersys, Inc. William (B.J.) Lehmann, J.D., President and Chief Operating Officer (216) 431-9900 bjlehmann@athersys.com In-Site Communications Lisa M. Wilson (917) 543-9932 lwilson@insitecony.com
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