CLEVELAND, July 25 /PRNewswire-FirstCall/ -- Athersys, Inc., a wholly owned subsidiary of BTHC VI , announced today that it has initiated a Phase I clinical trial in the United Kingdom for ATHX-105, the company’s oral, selective 5HT2c receptor agonist for treating obesity.
The serotonin 5HT2c receptor is a validated molecular target in the brain that regulates appetite and food intake. Compounds acting on this target have been shown to reduce appetite and result in weight loss in both animal models and humans. ATHX-105, which was developed internally, has been shown to stimulate the 5HT2c receptor without activating 5HT2b, a related receptor found in the heart and linked to adverse side effects affecting the cardiovascular system.
“ATHX-105 has the potential to be a best-in-class compound, based on its potency, selectivity, and the potential for once-a-day, oral administration,” said Dr. John Harrington, Chief Scientific Officer at Athersys. “In pre-clinical studies, ATHX-105 reduced food intake and body weight by suppressing appetite without appearing to cause the adverse side effects that have been observed with other weight loss drugs in this class.”
The Phase I clinical trial, approved by U.K. regulatory authorities, will involve 60 to 80 overweight, healthy subjects with a body mass index of 25 to 35. The trial is designed to assess the short-term safety, tolerability, and pharmacokinetics of ATHX-105 and to establish dose ranges for evaluation of efficacy in subsequent clinical studies. In the first part of the trial, ATHX-105 will be given as a single dose which will be escalated until a maximum tolerated dose is identified. In the second part of the trial, ATHX- 105 will be administered in ascending doses for one-week to evaluate the safety and tolerability of multiple doses. The safety evaluation will include the assessment of various cardiovascular parameters. The company expects to complete the trial in the first quarter of 2008. Concurrent with the Phase I clinical trial, Athersys is also conducting certain non-clinical studies needed for the commencement of subsequent clinical studies.
About Athersys
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’s lead product candidate, ATHX-105, is an oral, selective 5HT2c receptor agonist in Phase I clinical trials for the treatment of obesity. The company is developing other 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 is also developing MultiStem(R), a patented adult-derived, “off the shelf” stem cell product platform for multiple disease indications. The company is collaborating with Angiotech Pharmaceuticals, Inc. to develop MultiStem to treat damage caused by myocardial infarction and peripheral vascular disease. The company is independently developing MultiStem for bone marrow transplantation/oncology support, ischemic stroke and other indications.
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. 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 ability to successfully complete clinical trials for our product candidates, including the Phase I clinical trial for ATHX-105; 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.
Athersys, Inc.
CONTACT: William (B.J.) Lehmann, J.D., President and Chief OperatingOfficer of Athersys, Inc., +1-216-431-9900, Fax: +1-216-361-9495,bjlehmann@athersys.com
Web site: http://www.athersys.com/
