New York, NY October 21, 2011 –Fast Forward, LLC, a nonprofit subsidiary of the National Multiple Sclerosis Society and Athersys, Inc. (NASDAQ: ATHX) announced today an alliance to fund the development of Athersys’ MultiStem® adult stem cell platform for the treatment of Multiple Sclerosis (MS), including treatment of chronic progressive forms of the disease, with the goal of accelerating the clinical application of MultiStem for patients diagnosed with MS. Fast Forward will commit up to $640,000 to fund the advancement of the program to clinical development stage.
Under the terms of the Sponsored Research Agreement, Fast Forward will provide funds to enable preclinical testing of MultiStem in murine models of MS to support submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA). The aim of the IND would be to secure authorization from the FDA to conduct a clinical trial administering MultiStem to treat patients diagnosed with chronic progressive MS. Upon successful achievement of certain pre-determined development milestones, including successful completion of clinical development and commercialization, Athersys would remit certain milestone payments to Fast Forward.
“We are pleased to partner with Athersys to develop a new approach to treat MS with their proprietary platform, MultiStem,” said Timothy Coetzee, Ph.D., Chief Research Officer of the National MS Society and Fast Forward. “Fast Forward’s partnership with Athersys reflects our commitment to seek out and fund innovative biotechnology companies with products that address critical unmet needs for treating MS that could lead to improved quality of life for people living with this debilitating disease.”
MultiStem has shown promise in treating multiple disease indications in the neurological, cardiovascular, and inflammatory and immune disease areas. Athersys has advanced four MultiStem programs to clinical stage, including for the treatment of acute myocardial infarction, ischemic stroke, inflammatory bowel disease (where the Company is partnered with Pfizer), and for preventing graft vs. host disease following hematopoietic stem cell transplant.
“We are extremely proud of the innovative work we and our broad network of collaborators have been conducting in these areas of significant unmet medical need,” said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer of Athersys. “This collaboration not only underscores the promise and potential of MultiStem for treating Multiple Sclerosis, but will also help accelerate our ongoing efforts to develop novel, safe and effective treatments for patients in other neurological areas as well, especially those that involve chronic inflammation in the brain. We look forward to continuing to work with our development partners and to forging research relationships with visionary organizatons like Fast Forward for MS research to help us reach this goal.”
The project is intended to determine the optimal dosing approach and dose level for MultiStem administered in a mouse model of chronic MS. Additionally, the project will further evaluate and validate the safety of MultiStem infused intravenously into mice with chronic MS pathology via clinical pathology and histopathological evaluation by a certified clinical research organization.
Athersys is collaborating on this project with Case Western Reserve University School of Medicine under the leadership of Dr. Robert H. Miller, Ph.D., Vice President for Research, a prominent investigator in neural diseases including MS, brain tumors and cerebral palsy. Dr. Miller has published more than 120 papers in the area of neural development with a particular interest in the brain and spinal cord. He is a founding member of the Myelin Repair Foundation, a non-profit foundation based in California whose goal is to rapidly develop new therapies for MS. Dr. Miller's development research has focused on understanding the cellular and molecular mechanisms that regulate glial cell determination in the developing vertebrate central nervous system.
“Stem cell therapies have recently emerged as a potentially important approach to treating MS in recent years,” said Dr. Miller. “A major drawback with the cellular approach, however, is the variability in individual therapeutic cell populations. The ability to develop MultiStem for the treatment of MS would overcome such obstacles and be a major advance in MS cell-based therapies.”
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 is a patented and proprietary allogeneic cell therapy product candidate that can be manufactured on a large scale, frozen and stored for an extended period, and subsequently thawed and administered intravenously, similar to traditional biologics. MultiStem consists of a clinical grade preparation of non-embryonic stem cells obtained from bone marrow that have the potential to produce a range of factors and form multiple cell types. MultiStem appears to work through several mechanisms that promote healing and tissue repair, 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 may represent a unique “off-the-shelf” stem cell product based on its apparent ability to be used without tissue matching and its capacity for large scale production.
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 will accomplish 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 by funding cutting-edge research, driving change through advocacy, facilitating professional education, collaborating with MS organizations around the world, and providing programs and services designed to help people with MS and their families move their lives forward. We are people who want to do something about MS now, and are dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.
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 in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs, including for treating damage caused by myocardial infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and inflammatory bowel disease. The Company also has developed 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.
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, multiple sclerosis 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: final results from the Phase I clinical trial of MultiStem for heart attack patients; 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.
Fast Forward, LLC
Associate Vice President, Public Affairs, National MS Society
Tel: (212) 476-0436
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Lisa M. Wilson
Tel: (917) 543-9932