Positive Data Presented on Athersys' MultiStem to Treat Stroke

CLEVELAND and NEW ORLEANS, Feb. 3, 2012 (GLOBE NEWSWIRE) -- Medical researchers from The University of Texas Health Science Center at Houston (UTHealth) Medical School presented new research results this morning at the American Heart Association International Stroke Conference that highlight the role of the spleen in the mechanisms underlying how MultiStem^®, a novel allogenic stem cell therapy being developed by Athersys, Inc. (Nasdaq:ATHX), reduces damage and enhances functional recovery in animals after an ischemic stroke.

The study illustrated the potential benefits of MultiStem therapy for treating stroke using standard preclinical models. Researchers observed that intravenous administration of MultiStem one day after a stroke resulted in a substantial reduction in brain tissue loss 28 days post-stroke. The spleen is believed to play a significant role in the body's immune response to the stroke that can result in additional damage following the primary ischemic event. After administration, MultiStem cells limit the inflammatory cascade that results from the initial stroke, thereby reducing the secondary damage that occurs.

"A range of studies show that MultiStem can reduce tissue damage and promoting healing and repair in multiple ways following a stroke, as well as in other acute neurological injuries. This data confirms prior findings and extends our understanding of how MultiStem can work through several distinct and important mechanisms, illustrating how we might be able to have a dramatic impact on outcomes and standard of care for stroke victims," said Dr. Robert Mays, Head of Neuroscience at Athersys. "We are excited about our ongoing Phase 2 clinical trial for treating stroke, which is being conducted at leading stroke centers across the U.S., and is focused on treating stroke victims in a clinically practical time frame, within 1 — 2 days after the stroke. We believe this and other trials will enable us to demonstrate the clinical potential of MultiStem for stroke and other indications that represent substantial unmet clinical needs," concluded Dr. Mays. Athersys believes the stroke market represents a commercial opportunity of more than $15 billion annually.

In the preclinical model of stroke used in the study, animals that received treatment with MultiStem versus placebo showed statistically significant increases in the percentage of T regulatory (T_reg) cells, which may play an important role in the healing process, and decreases in inflammatory T cells, which are believed to exacerbate damage in the brain following a stroke; a statistically significant reduction in the pro-inflammatory cytokine levels of IL-1β and TNF-α; and a statistically significant increase in levels of the anti-inflammatory cytokine IL-10, also known as human cytokine synthesis inhibitory factor (CSIF). At four days after stroke, animals treated with MultiStem had reduced levels of the serum cytokine IL-6 compared with placebo.

These outcomes support prior research at UTHealth, in which researchers found that animals treated with MultiStem showed normal spleen size and increased levels of anti-inflammatory cytokines in the blood whereas animals treated with placebo showed a reduction in spleen size and an increase in inflammatory cytokines in the blood. Through its multiple pioneering trials and clinical practice, UTHealth has become a leader in developing stem cell therapies for stroke and other neurological disorders that can be translated quickly into patient care. 

About Stroke

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 blood clot that impedes blood flow in the brain. 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 in the U.S. will skyrocket from $64 billion in 2010 to $140 billion in 2030, representing a substantial increase in cost to the national healthcare system.  

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 a healthier future.

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, 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

Source: Athersys, Inc.

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