CLEVELAND, March 14, 2011 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today the initiation of patient enrollment, and dosing of the first patient for a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys' allogeneic cell therapy product for the treatment of ulcerative colitis (UC). This Phase II clinical trial is part of a strategic global collaboration between Athersys and Pfizer Inc. (NYSE:PFE) to investigate MultiStem for the treatment of inflammatory bowel disease (IBD).
The Phase II study is a randomized, double-blind, placebo-controlled, multi-center study designed to investigate the safety and efficacy of MultiStem in subjects with moderate to severe UC. The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include up to approximately 126 patients. Individuals participating in the study will receive multiple doses of either MultiStem or placebo, administered over a period of several weeks. Primary safety and efficacy endpoints will include endoscopic evaluation at baseline and at eight weeks, with a follow-up of all patients through twelve months.
"Despite treatment advances in recent years, Inflammatory Bowel Disease remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need," said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer of Athersys. "We're pleased with the continued progress of our partnership with Pfizer and excited about commencing the trial."
Dr. Ruth McKernan, Head of Pfizer Regenerative Medicine, added: "Both teams have worked very well together, and we are pleased to be commencing this Phase II trial in this innovative area."
About Inflammatory Bowel Disease
According to Datamonitor, more than two million individuals in the United States, core European markets and Japan suffer from various forms of IBD, including Crohn's Disease and UC, which is the most commonly diagnosed form of IBD. UC is a chronic, relapsing inflammatory condition involving all or a portion of the colon. Patients with UC most commonly present with diarrhea, urgency, rectal bleeding, and abdominal pain. Patients may also experience fatigue, fevers, weight loss, and dehydration. The symptoms can be incapacitating.
MultiStem is a patented and proprietary product candidate that can be manufactured on a large scale, subsequently frozen and later thawed and administered, 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, 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 or immunosuppression and its capacity for large scale production.
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, including 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 .
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Forward Looking Statements of Athersys
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, 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: 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.
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