February 10, 2011

Researchers From UTHealth and Athersys Present Preclinical Data Illustrating Potential Benefits of MultiStem(R) for Treating Stroke

Results Show How Adult Stem Cell Therapy Reduces Inflammatory Damage and Improves Functional Recovery in Preclinical Models of Ischemic Stroke

HOUSTON and LOS ANGELES, Feb. 10, 2011 (GLOBE NEWSWIRE) -- Medical researchers from The University of Texas Health Science Center at Houston (UTHealth) presented new research results at the American Heart Association International Stroke Conference that demonstrated how MultiStem®, a novel stem cell therapy being developed by Athersys, Inc. (Nasdaq:ATHX), provided multiple benefits when administered in preclinical models of ischemic stroke. The study, conducted by leading researchers from the Department of Neurology at the UTHealth Medical School working in collaboration with scientists at Athersys, illustrated the potential benefits of MultiStem therapy for treating stroke. Researchers observed that intravenous administration of MultiStem one day after a stroke reduced inflammatory damage in the brain and resulted in a significant improvement in motor skills. 

"We are seeing a paradigm shift in the way some types of stem cells may enhance recovery from stroke," said Sean I. Savitz, M.D., principal investigator and associate professor of neurology at UTHealth. "The stem cells may actually exert some of their effects on other organs such as the spleen. The spleen seems to play an important role in some neurological disorders by contributing, for example, to ongoing inflammation and brain injury after stroke. We're finding these stem cells are working on dampening inflammation involving the spleen."

According to the American Heart Association, approximately 800,000 individuals suffer a stroke each year in the United States, and an estimated 2 million individuals suffer a stroke each year in the U.S., Japan, and major European countries combined.  Approximately 85% of strokes are ischemic, meaning they are caused by a blockage of blood flow in the brain, which occurs as a result of a clot or "thrombus". Currently there is only one FDA-approved drug therapy for the treatment of ischemic stroke, the thrombolytic tPA, which helps to dissolve the flow-impeding blood clot. However, tPA must be administered within several hours from when the stroke has occurred in order to be effective.   Due to its limited window, only about 5% of all patients who could potentially benefit from therapy with tPA actually receive treatment. Given the lack of effective therapies, many patients who suffer a stroke require extensive physical therapy or experience significant or permanent disability, and as a result, must receive long-term institutional care or be cared for by a family member. As a consequence of an aging population, recent forecasts from the American Heart Association project that the prevalence of stroke will increase by 25% in the next 20 years, and the total estimated annual cost for treating and caring for stroke survivors will skyrocket from $64 billion in 2010 to $140 billion in 2030, representing a substantial increase in cost to the national healthcare system.  

In the rat model of stroke used in the study, animals that received treatment with MultiStem showed statistically significant improvement in motor skills relative to animals that received placebo, and also showed reduced cell death, reduction of inflammatory cytokines and an increase in anti-inflammatory cytokines. Interestingly, researchers found that animals treated with placebo showed a reduction in spleen size and an increase in inflammatory cytokines in the blood, whereas animals that were treated with MultiStem showed normal spleen size and increased levels of anti-inflammatory cytokines in the blood. The spleen is believed to play a significant role in promoting and sustaining the inflammation that can result in substantial long-term damage following brain injury.

"Ischemic stroke represents an enormous clinical, economic and social burden that is expected to increase dramatically in the years ahead as a result of an aging population, and the corresponding increase in the number of individuals that are susceptible to all forms of cardiovascular disease," said Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys. "MultiStem appears to have profound effects in multiple neurological injury models, by reducing inflammation, protecting at-risk brain tissue, and promoting tissue repair. If we can develop new, more effective therapies that meaningfully extend the treatment window for stroke victims, we can improve clinical care, reduce long-term health care costs, and improve the quality of life for millions of people."

UTHealth is a national leader in translational stem cell research for the treatment of stroke and other neurological injuries, and recently initiated a first-of-its-kind clinical trial using bone marrow stem cells for acute stroke, which is being led by Dr. Savitz and funded by the National Institutes of Health. Recent preclinical data published by researchers in the Department of Pediatric Surgery at UTHealth working in collaboration with Athersys showed that administration of MultiStem following traumatic brain injury also had a profound effect on reducing the inflammatory response emanating from the spleen, accelerated repair of the blood-brain barrier and limited the neurological damage following injury. Both studies were done in conjunction with UTHealth's major teaching hospitals Memorial Hermann-Texas Medical Center and Children's Memorial Hermann. Preclinical studies involving administration of MultiStem for stroke and traumatic brain injury were funded by Athersys, Inc.

About The University of Texas Health Science Center at Houston (UTHealth)

The University of Texas Health Science Center at Houston (UTHealth), the most comprehensive academic health system in The University of Texas System and the U.S. Gulf Coast region, is home to schools of biomedical informatics, biomedical sciences, dentistry, medicine, nursing and public health. It also includes a psychiatric hospital, multiple institutes and centers, and a growing network of clinics and outreach programs in education and care throughout the region. The university's primary teaching hospitals include Memorial Hermann-Texas Medical Center, Children's Memorial Hermann Hospital and Lyndon B. Johnson General Hospital. Founded in 1972, its faculty, staff and students are committed to delivering innovative solutions that create the best hope for a healthier future.

About MultiStem®

MultiStem is a patented and proprietary product consisting of a clinical grade preparation of adult (non-embryonic) stem cells obtained from bone marrow that have the potential ability to produce a range of factors and form multiple cell types. MultiStem appears to work through several mechanisms, but a primary mechanism appears to be the production of therapeutic proteins and other 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.

About Athersys

Athersys is a clinical stage biopharmaceutical 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 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 and oncology treatment support, ischemic stroke, and inflammatory bowel disease. The Company is also developing a portfolio of other therapeutic programs, including 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 has forged several key strategic alliances 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," "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, 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: 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: Deborah Lake

         Media Relations, UTHealth

         713-500-3304; 713-500-3030 24/7 hotline

         Deborah.M.Lake@uth.tmc.edu



         William (B.J.) Lehmann, JD

         President and Chief Operating Officer

         216-431-9900

         bjlehmann@athersys.com

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Source: Athersys, Inc.

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