Athersys Announces Summary Results for Phase 1 Safety Study of Its Novel Obesity Drug
ATHX-105 Exhibits Safety and Tolerability in Single and Multidose Studies
Conference Call Today At 4:15 PM (Eastern Time)
CLEVELAND, Feb. 27, 2008 (PRIME NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced top-line results from its Phase 1 clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity. ATHX-105 was well-absorbed, providing good drug exposures, well-tolerated up to high doses, and had no negative effect on cardiovascular, hematology or other clinical parameters.
"We are pleased with the results of our Phase 1 study," said Gil Van Bokkelen, Ph.D., Athersys Chairman and CEO. "The data is in line with our expectations for ATHX-105, a highly selective 5HT2c agonist. As we have previously noted, we believe that high selectivity for 5HT2c relative to other receptors, such as 5HT2b and 5HT2a, is key to safety and tolerability. We believe that these results support the view that better selectivity results in superior tolerability for drugs in this class, which is an important factor for achieving effectiveness and patient compliance."
The Phase 1 clinical study was a randomized, double-blinded, placebo controlled study in healthy male and female volunteers to evaluate the safety, tolerability, and pharmacokinetics of ATHX-105. The study was carried out in two parts -- a single ascending dose portion and a multiple ascending dose portion, evaluating daily dosing for 7 days, and was conducted in the United Kingdom. In total, 107 subjects were evaluated.
The highlights of this study include:
* The single ascending dose part evaluated doses of 2, 6, 20, 50, 100 and 150 mg of ATHX-105. The maximum tolerated dose (MTD) was determined to be 100 mg. At high doses, the most common side effects included headache, nausea and dizziness, and these were generally mild and transient. * The multiple ascending dose part evaluated doses up to 75 mg once per day and 50 mg twice per day. The drug was generally well-tolerated. * ATHX-105 had no clinically significant effects on heart-rate, blood pressure, or EKG parameters at any dose. The drug had no clinically significant effects on any hematology or clinical chemistry parameters at any dose. In addition, there were no serious adverse events, and no discontinuations from the study due to adverse events. * ATHX-105 was well-absorbed leading to good drug exposures following oral administration. Drug exposure and maximum drug concentrations were dose proportionate. In the fed-fasted cohort, food consumption had no apparent effect on drug exposure.
"Based on these favorable results, we intend to continue with our plans and activities for initiating a Phase 2 study later this year," concluded Dr. Van Bokkelen.
Athersys will host a conference call today at 4:15 PM (Eastern Time) to review the top-line data results of the Phase 1 clinical trial of ATHX-105, its leading drug development candidate for the treatment of obesity.
Gil Van Bokkelen, Chairman and Chief Executive Officer, William (B.J.) Lehmann, President and Chief Operating Officer, and John Harrington, Executive Vice President and Chief Scientific Officer, will host the call.
Investors and other interested parties are invited to listen to the conference call by dialing 800-273-1254 in the U.S. and Canada, 706-679-8592 from abroad, or via a live Internet broadcast on the company's website at www.athersys.com, under the Investor Relations section.
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM (Eastern Time) on March 12, 2008, at the aforementioned URL, or by dialing 800-642-1687 in the U.S. and Canada, or 706-645-9291 from abroad, and entering access code 34937079.
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. In addition to its lead product candidate, ATHX-105, 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 developing MultiStem(r), 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.
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CONTACT: Athersys, Inc. William (B.J.) Lehmann, J.D., President and Chief Operating Officer (216) 431-9900 firstname.lastname@example.org
In-Site Communications Lisa M. Wilson (917) 543-9932 email@example.com
Posted: February 2008