Publication Indicates That MultiStem Treatment May Reduce Inflammation and Promote Reparative Processes Following Acute Brain Injury

Wed Oct 10, 2012 7:00am EDT

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CLEVELAND, Oct. 10, 2012 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today the publication of an article in the peer-reviewed scientific journal, Journal of Neuroinflammation, that describes the results of a preclinical study evaluating the administration of MultiStem® cell therapy for the treatment of traumatic brain injury (TBI) in rodents. The article, authored by investigators from The University of Texas Health Science Center at Houston (UTHealth), together with scientists from Athersys, describes preclinical study results demonstrating that administration of MultiStem cells modulates the inflammatory environment that follows TBI, by reducing immune cell and cytokine activity associated with inflammation.

TBI affects approximately 1.7 million patients in the United States annually and severe injuries can be associated with significant long-term physical, cognitive and psychological deficits.  As in other acute injuries and diseases affecting the central nervous system, such as stroke and spinal cord injury, TBI leads to substantial inflammation, which slows innate recovery processes and contributes to secondary tissue damage.

The publication further illustrates the mechanisms through which cellular therapy may provide benefit to patients suffering significant injury to the central nervous system. "MultiStem therapy shows promise for treating traumatic brain injury, as well as ischemic stroke and spinal cord injury," said Dr. Robert Mays, Head of Neuroscience at Athersys.  "These latest preclinical results further confirm that MultiStem cells have substantial anti-inflammatory and immunomodulatory properties that could be important in treating multiple central nervous system disease conditions."

In pre-clinical experiments, rodents underwent controlled cortical impact brain injury receiving either MultiStem cells or placebo following the injury. The injured, cell-treated animals had significant increases in T-regulatory cells in the spleen and plasma at 24 and 48 hours, respectively, compared to the placebo-treated animals. Further, MultiStem treatment was associated with an increase in the ratio of neuroprotective (M2) macrophages relative to proinflammatory (M1) macrophages responsible for the production of inflammatory cytokines and associated neurotoxicity.  Additionally, cell treatment resulted in a reduction of blood brain barrier permeability and preserved splenic mass following the injury, suggesting that MultiStem treatment may provide benefit to TBI patients through multiple pathways.

Dr. Charles S. Cox, M.D., the senior author on the publication and the Distinguished Professor at the UTHealth Medical School and Director of the Pediatric Trauma Program at Children's Memorial Hermann Hospital in Houston, commented on the importance of the publication.  Dr. Cox stated, "This work further elucidates the mechanisms by which MultiStem alters the detrimental effects of the innate immune response to injury.  By understanding these mechanisms, effective treatment strategies using MultiStem may be developed."

About MultiStem

MultiStem® cell therapy is a patented 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 cell therapy for use with a bone allograft product in the orthopedic market.

About Athersys

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.  The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas.  The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease.  Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.

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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," "suggest," "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, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction, stroke and other disease indications, including traumatic brain injury, and the prevention of graft-versus-host disease. 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: our ability to raise additional capital; final results from our MultiStem clinical trials including for ischemic stroke; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; 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 ability to meet milestones under our collaboration agreements; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; 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.
 

CONTACT: William (B.J.) Lehmann, J.D.
         President and Chief Operating Officer
         Tel: (216) 431-9900
         bjlehmann@athersys.com
         
         Investor Relations:
         Lisa M. Wilson
         In-Site Communications
         Tel: (917) 543-9932
         lwilson@insitecony.com
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