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Press release from GlobeNewswire (a Nasdaq OMX company)

Athersys Presents New Data Demonstrating Potential Benefits From MultiStem After Spinal Cord Injury

Monday, October 15, 2012

Athersys Presents New Data Demonstrating Potential Benefits From MultiStem After Spinal Cord Injury08:30 EDT Monday, October 15, 2012CLEVELAND, Oct. 15, 2012 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) presented new research results this morning at the Society for Neuroscience annual meeting in New Orleans, demonstrating the potential for MultiStem®, a novel stem cell therapy being developed by Athersys, to treat spinal cord injury (SCI). The work conducted by Athersys scientists, in collaboration with scientists from Case Western Reserve University School of Medicine, and with grant support from the Ohio Third Frontier, illustrates the potential benefits of MultiStem therapy for treating SCI. In a preclinical rodent model of SCI, researchers observed that intravenous administration of MultiStem cells one day after injury results in accelerated recovery, significant improvements in locomotor function and fine motor tests, and significant improvement in bladder function. According to the Christopher & Dana Reeve Foundation, there are currently more than 1,200,000 people in the United States living with spinal cord injury, with a range of 15,000 to more than 50,000 new cases each year. The long-term cost of spinal cord damage is estimated to be from $500,000 to more than $3 million per patient, depending on the severity of the injury. Among other SCI complications, loss of bladder control is considered a major issue by SCI patients. "Spinal cord injury can be devastating to patients and their families," said Robert Mays, Ph.D., Head of Neuroscience at Athersys. "These results suggest that an off-the-shelf cell therapy, such as MultiStem, administered intravenously shortly after the injury, may have the potential to provide substantial and meaningful benefits to patients." In preclinical experiments, rodents with SCI from contusion in the thoracic region were given an intravenous injection of vehicle or MultiStem cells one day after the injury. The animals treated with MultiStem showed significant and sustained improvement in gross locomotor and fine motor function compared to vehicle treated animals over the ten week evaluation period. Additionally, significant improvements in bladder function were observed in the animals treated with MultiStem shortly after the SCI. These results build on previous data, published in 2011 in the Journal of Neuroscience, demonstrating that this cell therapy reduces inflammation in the region of injury and also promotes the regrowth of neurons in the site of injury. Jerry Silver, PhD, the lead academic investigator on the project and a Professor in the Department of Neurosciences at Case Western Reserve School of Medicine, commented on the potential for intravenous administration of MultiStem to benefit SCI patients. "I am excited by this non-invasive, acute-treatment approach which represents a novel treatment strategy with the potential to safely and more effectively treat acute spinal cord injury and its related complications." This work was supported by a grant from the Ohio Third Frontier.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. The Athersys, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4548Forward-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 lysosomal storage disorders, 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; 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