April 10, 2013

Publications Demonstrate Relevance of MultiStem(R) for Autoimmune Disease, Transplantation and Vascular Disease

Collaborative Stem Cell and Regenerative Medicine Research Conducted by Athersys and Colleagues at Pfizer, King's College, London and Oregon Health Sciences University

CLEVELAND, April 10, 2013 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today the recent publication of articles in two peer-reviewed scientific journals, Journal of Immunology and Circulation, that describe the potential for multipotent adult progenitor cells (MAPC®s), or MultiStem® cells, to provide benefit in autoimmune disease and in peripheral vascular disease (PVD), respectively. The articles also describe specific biological mechanisms by which this cell therapy delivers benefit in these areas and illustrate the strong scientific foundation supporting MultiStem cell therapy. These findings may support clinical investigation in these areas and represent important, additional commercial opportunities for the company's MultiStem franchise.

The Journal of Immunology article (April 1, 2013, epub ahead of print), authored by scientists at King's College, London, Pfizer Inc. and Athersys, describes the results of a study using allogeneic islet transplantation (an approach for treating Type 1 diabetes) as a model to assess the ability of MultiStem cells to control the T cell responses that play an important role in autoimmune disease and allograft rejection. The MultiStem cells suppressed T cell proliferation and Th1 and Th17 cytokine production, increased anti-inflammatory IL-10 production, suppressed autoreactive T cell activity, and supported the proliferation of regulatory T cells, which resulted in durable control of potentially damaging inflammatory T cells. Aberrant T cell activity contributes significantly to a number of inflammatory and immune-mediated conditions, including Type 1 diabetes, graft-versus-host disease, solid organ transplantation, inflammatory bowel disease, and other autoimmune diseases, such as scleroderma, lupus and rheumatoid arthritis.  

The Circulation article (2013; 127:710-719), authored by investigators at the Oregon Health & Science University (OHSU) together with scientists from Athersys, describes the results of a study using advanced imaging technologies to evaluate the administration of MultiStem cell therapy in a rodent hind-limb ischemia model. Ultrasound imaging of the ischemic limb following MAPC treatment showed more complete recovery of blood flow and greater expansion of microvascular blood volume in MAPC-treated animals. In addition, the study confirmed that this effect was in part related to endothelial activation and enhanced recruitment of endogenous proangiogenic cells resulting from the MAPC treatment. Critical limb ischemia (CLI), an advanced from of PVD, is characterized by severe decline of blood flow causing persistent and severe pain in the lower extremities and eventually leads to ulcerations and gangrene resulting in amputations and a significant death rate. CLI may affect more than five million people in the U.S., Europe and Japan, and this is expected to increase with an aging population and the growing prevalence of diabetes.

"These publications further illustrate the mechanisms through which MultiStem therapy may provide benefit to patients," said Dr. Robert Deans, Executive Vice President of Regenerative Medicine at Athersys. "These latest results further confirm that MultiStem cells are not one dimensional — they have the capacity to act in a dynamic manner and convey therapeutic effects through multiple modes of action depending on the disease or condition. This is a central paradigm that distinguishes cell therapy from single modality drugs and biologics, and represents an important potential advancement in the treatment of disease." 

Since 2012, Athersys researchers and investigators at collaborating institutions have published seven articles in quality peer-reviewed journals, further describing the MultiStem cells' mechanisms of action and potential applications, as well as the breadth and quality of its third party research collaborations.

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=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," "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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Source: Athersys, Inc.

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