CLEVELAND, March 4, 2009 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced it will host its first annual Investor Day being held at the Intercontinental Hotel on Wednesday, April 8th, 2009 in New York City. The meeting will begin promptly at 8:30 a.m. Eastern Time and end at approximately 11:30 a.m. Eastern Time. Advance registration will be available at the company website, at www.Athersys.com, or will be available onsite at the event beginning at 7:30 a.m.
"We are pleased to have this opportunity to provide an update regarding the progress being made in our key programs, including our stem cell programs applying MultiStem(r) in multiple disease areas, and our small molecule programs," said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer at Athersys. "We are committed to developing a portfolio of best-in-class therapeutic products, and we will use this event to describe why we remain confident we are on track to achieve that goal in multiple areas."
MultiStem is a patented and proprietary stem cell therapy being developed by Athersys that the Company believes represents a potential best-in-class therapy in the field of regenerative medicine. Based on work conducted by the Company and independent collaborators at leading clinical and research institutions over the past several years, MultiStem has demonstrated broad potential for treating ischemic disease, disorders involving the immune system, and certain neurological conditions.
Highlights of the program will include:
* Presentations by senior management including: Gil Van Bokkelen, Chairman and Chief Executive Officer, William (B.J.) Lehmann, President and Chief Operating Officer, John Harrington, Chief Scientific Officer, and Robert Deans, Senior Vice President of Regenerative Medicine. * An update of the status of the Company's key stem cell development programs including application of MultiStem toward the treatment of multiple diseases, including two ongoing clinical studies in acute myocardial infarction and cancer treatment support in leukemia and lymphoma patients. A key focus of the event will be to provide a detailed overview of the product profile, including manufacturing, safety and efficacy data from multiple studies. * An update on other key drug development programs at the Company, including the H3 antagonist program, which has potential relevance for treating multiple conditions, including attention or cognitive disorders, and conditions that affect wakefulness. The Company will also review its 5HT2c agonist program for the treatment of obesity.
Institutional investors and analysts interested in attending should contact Lisa Wilson, Investor Relations for Athersys, either via telephone at 1-917-543-9932 or e-mail at: lwilson@insitecony.com.
About Our Programs
MultiStem
Athersys is developing MultiStem as the first "off-the-shelf" stem cell therapy product that can be manufactured on an industrial scale, which the Company believes represents a major advance in the field of stem cell medicine. MultiStem is isolated from healthy consenting donors and then expanded to produce a frozen stem cell bank. Unlike other stem cells, by using cells obtained from a single donor and expanded using proprietary processes, hundreds of thousands or even millions of doses of MultiStem may be produced. Importantly, MultiStem is administered without tissue matching or the need for immune suppressive drugs, and has shown the potential to deliver a therapeutic benefit in multiple ways, such as through the dynamically regulated production of factors that reduce inflammation, protect damaged or injured cells, and promote tissue repair and healing.
Recently, Athersys was selected by Frost & Sullivan, a global research and consulting firm, to receive the 2008 North American Product Innovation of the Year Award in recognition of the best-in-class profile of MultiStem, which is in clinical and preclinical development for multiple disease indications. Current programs include applying MultiStem toward the treatment of cardiovascular disease, cancer treatment support, ischemic stroke and a range of other conditions involving ischemic injury or immune system function.
"We are excited by the progress being made and the potential breadth of MultiStem toward treating a range of diseases and conditions that represent substantial, unmet medical needs. These represent a significant burden to the global healthcare system. We believe this technology has the potential to make stem cell medicine a reality for many patients," said Dr. Van Bokkelen.
In December, Athersys announced that it received authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial evaluating the safety of administration of MultiStem in the treatment of ischemic stroke. This represented the third IND authorized by the FDA for MultiStem within a year, and the trial would represent the first clinical study in the U.S. of an off-the-shelf stem cell therapy product candidate for treatment of ischemic stroke.
Histamine H3 Receptor Antagonist Program
In addition to its stem cell and regenerative medicine programs, Athersys is also developing H3 antagonists to treat certain cognitive disorders, and conditions such as narcolepsy, excessive daytime sleepiness, and chronic fatigue associated with certain diseases such as Parkinson's. The H3 receptor regulates levels of histamine and other neuro-transmitters in certain areas of the brain that play a direct role in regulating cognitive functions and wakefulness. The histamine H3 receptor antagonists being developed at Athersys represent a new class of drugs that could have an improved efficacy and safety profile relative to existing drugs used for the treatment of various conditions affecting attention and cognitive function, including attention deficit disorder, schizophrenia or other indications.
5HT2c Agonist Program
In addition to its other programs, Athersys is developing potent, selective 5HT2c receptor agonists for the treatment of obesity. The 5HT2c serotonin receptor plays an important role in the regulation of appetite, and numerous prior studies have demonstrated that stimulation of the 5HT2c receptor causes a significant reduction in appetite, resulting in weight loss over time. In 2008, the Company completed three Phase I safety studies of its lead obesity candidate, ATHX-105. However, after consultation with the FDA, the Company has decided to suspend further development of this compound, and is currently focusing on the advancement of next generation compounds that exhibit improved characteristics.
About Athersys, Inc.
Athersys is a 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/oncology support, ischemic stroke and other indications. 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). More information is available at www.athersys.com.
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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 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, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of a variety of 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; 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 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.