CLEVELAND, October 5th, 2012 – Athersys, Inc. (NASDAQ: ATHX) announced today it is presenting new research results at the Second Midwest Conference on Stem Cell Biology & Therapy at Oakland University in Rochester, Michigan, that highlight the potential for MultiStem®, its proprietary adult stem cell therapy, to treat multiple sclerosis (MS).
The work conducted by Athersys scientists, in collaboration with Robert Miller, Ph.D. and other scientists from Case Western Reserve University School of Medicine, and with the support of Fast Forward, a subsidiary of the National Multiple Sclerosis Society, demonstrates the potential benefits of MultiStem therapy for treating MS. In standard preclinical models of MS, researchers observed that MultiStem administration results in sustained behavioral improvements, arrests the demyelination process that is central to the pathology of MS, and supports remyelination of affected axons.
“MultiStem therapy has shown promise in treating multiple disease indications in the neurological and inflammatory and immune disease areas,” said Robert Mays, Ph.D., Head of Neuroscience at Athersys. “Multiple sclerosis presents as a neurological disorder, but a central component underlying the disease is immune system dysfunction. The results of our latest preclinical studies confirm that the immunomodulatory and regenerative properties of MultiStem therapy could have relevance for treatment of this disease.”
In preclinical experiments, rodents were given either an intravenous injection of MultiStem cells or placebo after the onset of symptoms in an MS model. The rodents treated with MultiStem displayed sustained and statistically significant improvement in functional testing compared to placebo treated animals. This functional improvement correlated with a statistical decrease in demyelinated lesions in the nervous system of cell treated animals compared to placebo as well as increased remyelination in cell treated animals, and this result has been confirmed in a second animal model of MS, suggesting that MultiStem treatment may accelerate the process of axonal remyelination.
“Long-term successful treatment of demyelinating diseases, such as MS, will likely require both the regulation of the immune system and the promotion of remyelination to protect axonal integrity,” said Robert Miller, Ph.D., Vice President for Research and Technology Management at Case Western Reserve University. Miller also serves as Director of the Center for Translational Neuroscience at the university’s School of Medicine. “I am pleased that the most recent studies suggest that MultiStem treatment influences both aspects of the disease, which means it has great potential as an attractive therapeutic option.”
In 2011, Athersys and Fast Forward, LLC, a nonprofit subsidiary of the National Multiple Sclerosis Society, announced an alliance to fund the development of MultiStem for the treatment of MS, including treatment of chronic progressive forms of the disease. Fast Forward committed up to $640,000 to fund the advancement of the program to the clinical development stage.
MS is a chronic, unpredictable neurological disease that affects the central nervous system. It is thought to be an autoimmune disorder, meaning the immune system incorrectly attacks healthy tissue. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. These problems may be permanent or may come and go. According to the National MS Society, at least 400,000 Americans have MS, and every hour someone is newly diagnosed. MS affects about 2.1 million people worldwide.
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.
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.
About Fast Forward, LLC
Fast Forward, LLC is a nonprofit organization established by the National Multiple Sclerosis Society in order to accelerate the development of treatments for MS. Fast Forward accomplishes its mission by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. More information can be found at www.fastforward.org.
About The National Multiple Sclerosis Society
The National MS Society addresses the challenges of each person affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move forward with their lives. In 2011 alone, through its national office and 50-state network of chapters, the Society devoted $164 million to programs and services that assisted more than one million people. To move us closer to a world free of MS, the Society also invested $40 million to support more than 325 new and ongoing research projects around the world. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.
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, 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.