updated 11/8/2010 7:45:48 AM ET 2010-11-08T12:45:48

CLEVELAND, Nov. 8, 2010 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today that the U.S. Food and Drug Administration (FDA) has authorized commencement of a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys' allogeneic investigational cell therapy product, for the potential treatment of ulcerative colitis. This Phase II clinical trial is expected to begin enrolling patients before the end of 2010 and is part of a collaboration between Athersys and Pfizer that the companies formed in December 2009 to develop MultiStem for the treatment of inflammatory bowel disease (IBD). 

The Phase II study will be a randomized, double-blind, placebo-controlled, multi-center study to investigate the safety and efficacy of MultiStem in subjects with moderate to severe ulcerative colitis. The trial is designed to include approximately 126 patients. Patients participating in the study will receive multiple doses of either MultiStem or placebo, administered over eight weeks. Clinical efficacy endpoints will be examined through week 16 with follow-up of patients for 12 months. The study will be conducted at clinical centers in North America and Europe. 

This is the fourth clinical study of MultiStem authorized by the FDA and the first in the autoimmune disease area. "This announcement demonstrates exciting progress, achieved within a year of launching the collaboration, and reflects the tremendous effort on the part of the teams at both organizations that are working together to advance this program in a focused and efficient manner," said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer of Athersys. 

"This is a very exciting day as we celebrate this milestone achieved with our collaborator Athersys," said Ruth McKernan, Senior Vice President and Pfizer Regenerative Medicine Chief Scientific Officer.  "The speed at which this has occurred is an indicator of the depth of the collaboration between the Pfizer Regenerative Medicine and Athersys teams.  We look forward to continuing to work together on this program."

About Inflammatory Bowel Disease

According to Datamonitor, more than 2 million individuals in the United States, core European markets and Japan suffer from various forms of IBD, including Crohn's Disease and ulcerative colitis (UC), which is the most commonly diagnosed form of IBD. Ulcerative colitis 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.

About MultiStem

MultiStem is a patented and proprietary product consisting 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 represents 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. 

About Athersys

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 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®). 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 .

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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 IBD, acute myocardial infarction, stroke and other disease indications, and the prevention of GvHD. 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 IBD; 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.

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