Healthcare Industry News:  cell therapy 

Regenerative Medicine Neurology

 News Release - September 20, 2010

Athersys Announces Groundbreaking Data Showing Neuroprotective Effects of MultiStem Therapy for Traumatic Brain Injury

Results Illustrate Broad Potential Therapeutic Value of Athersys' Adult Stem cell therapy Platform; Study Published in Experimental Neurology

CLEVELAND, Sept. 20, 2010 -- (Healthcare Sales & Marketing Network) -- Athersys, Inc. (Nasdaq:ATHX ) announced today the publication of a key study in the October issue of Experimental Neurology conducted by researchers at Athersys, the University of Texas Medical School, the Michael E. DeBakey Institute for Comparative Cardiovascular Science and Biomedical Devices, and Texas A&M University. This study demonstrates that intravenous injection of MultiStem(R), Athersys' multipotent adult progenitor stem cell therapy product, provides neurovascular protection after traumatic brain injury (TBI) in an established preclinical model of brain injury. The publication outlines how the administration of MultiStem enabled the preservation of the "blood brain barrier", and also reduced the effects and extent of the brain injury.

"Our results indicate that multipotent adult progenitor cells could provide multiple benefits in the context of neurological injury," said Charles S. Cox, Jr., M.D., Children's Fund, Inc. Distinguished Professor of Pediatric Surgery and Director of Pediatric Trauma Program at the University of Texas Medical School at Houston and co-author of the study. "The idea that the administration of MultiStem after a traumatic brain injury could potentially act to modulate the body's systemic immunologic and inflammatory response via other organ systems is both exciting and groundbreaking."

The paper, "Intravenous multipotent adult progenitor cell therapy for traumatic brain injury: Preserving the blood brain barrier via an interaction with splenocytes," describes a series of preclinical in vivo and in vitro experiments evaluating the effect of intravenous injection of MultiStem on neurovascular protection after traumatic brain injury. Traumatic brain injury causes a reduction in splenic mass that correlates with an increase in circulating immune cells, that subsequently leads to increased blood brain barrier permeability, thereby worsening the neurological deficit associated with the injury. As outlined in the publication, the findings showed that the intravenous injection of MultiStem preserved splenic mass and the integrity of the blood brain barrier, which in turn, can potentially reduce the neurobehavioral deficit associated with traumatic brain injury.

"This study provides further validation of MultiStem as an allogeneic adult stem cell therapy with broad potential therapeutic value for the treatment of a variety of conditions, and corresponds with findings from our other studies in other neurological areas," said Gil Van Bokkelen, Ph.D., CEO of Athersys. "MultiStem's multiple modes of action, consistent safety profile, and potential for off-the-shelf administration, represents a significant opportunity to help treat serious and life-threatening diseases, including ischemic injury, conditions involving the immune system, and certain types of trauma. We look forward to further exploring the clinical utility of MultiStem across various indications, and advancing key programs."

Traumatic brain injury is the cause for more than 50,000 deaths in the U.S. each year, according to the U.S. Centers for Disease Control (CDC). The CDC also estimates that there are 275,000 hospitalizations for moderate to severe traumatic brain injury and nearly 1.4 million emergency room visits for mild traumatic brain injuries each year, accounting for almost a third of all emergency room visits. These injuries yield significant direct and indirect medical costs - an estimated $60 billion in the U.S. alone, according to the CDC's website.

About MultiStem

MultiStem is a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow or other tissue sources of healthy, consenting adult donors, which have demonstrated the ability to produce a range of factors, as well as form multiple cell types. MultiStem appears to promote tissue repair and healing in multiple ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on work that demonstrates the ability to deliver multiple mechanisms of therapeutic benefit, administration of the product without tissue matching or immunosuppression, and its capacity for large-scale production. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with Angiotech to develop MultiStem in acute myocardial infarction and other cardiovascular indications.

About Athersys, Inc.

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(R), 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(R)). Athersys has forged 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

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 and other disease indications. 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 a phase II clinical trial of MultiStem for AMI; 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 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.

Source: Athersys

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