CLEVELAND, Sept. 23, 2008 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that the U.S. Food and Drug Administration (FDA) has requested additional information relating to the Company’s Investigational New Drug (IND) application for a 12-week Phase II clinical trial of ATHX-105, the Company’s lead product candidate for obesity, and has placed the study on partial hold. Athersys believes that the comments made by the FDA can be addressed with data from ongoing or recently conducted studies, including two recently completed Phase I studies which are described below. These studies provide further safety and tolerability data for ATHX-105 and also indicate that the drug is well absorbed throughout the gastrointestinal tract, thereby demonstrating the potential for development of a once-per-day controlled release formulation. The Company plans to submit data from these additional studies, address the FDA’s questions and comments, and discuss the clinical development plans for ATHX-105 with the agency.
