NEW YORK, Nov. 8 /PRNewswire-FirstCall/ -- Manhattan Pharmaceuticals, Inc. today announced that it has expanded the clinical trial sites for its ongoing Phase 2a study of oral Oleoyl-estrone (OE) in obese adult subjects to the United States. OE is the Company’s orally administered product candidate in development for the treatment of obesity.
In addition to recruiting patients in Switzerland, where the Phase 2a was initiated in May 2006, the study will now also begin recruiting patients at Jean Brown Research in Salt Lake City, UT and at Pennington Biomedical Research Center in Baton Rouge, LA. Screening of patients has already begun and dosing is expected to take place in mid November 2006.
This ongoing Phase 2a study is a randomized, double-blind, placebo- controlled, parallel group study. Approximately 100 obese adult subjects with a body mass index (BMI) of 27-38.9 will be randomized into one of four treatment groups to evaluate safety, preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles of 5mg, 10mg, or 20mg of oral OE compared to placebo given once daily during each 14-day dosing cycle. In addition to safety and tolerability, this Phase 2a study is also designed to further evaluate weight loss, maintenance of weight loss, and other therapeutic outcomes.
Manhattan Pharmaceuticals also recently announced the initiation of a second Phase 2a clinical trial of OE in morbidly obese male subjects (BMI 40- 55) being conducted at St. Luke’s-Roosevelt Hospital Center.
OE is an orally administered, synthetic form of oleoyl-estrone, a molecule that exists naturally in the body. As shown in animal studies, it is believed to work by a dual mechanism of action. Centrally, OE appears to act at the hypothalamus, resetting the body’s ponderostat, the “food control center” in the brain that detects and integrates signals that control both appetite and metabolic behavior. Peripherally, OE also causes reduced storage of fat in “white fat” tissue and allows skeletal muscle to use fat as an alternate energy source.
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc., a development-stage pharmaceutical company, acquires and develops proprietary prescription drugs for large, underserved patient populations. In view of the worldwide obesity epidemic, the company is developing OE, an orally administered novel therapeutic for the treatment of obesity, including morbid obesity. To meet the needs of other major, underserved medical markets Manhattan Pharmaceuticals is also developing PTH (1-34), a peptide believed to be a regulator of epidermal cell growth, for the treatment of psoriasis, and Propofol Lingual Spray, a convenient, proprietary lingual spray formulation of propofol, the world’s best-selling general anesthetic, as a sedative-hypnotic for use during diagnostic and therapeutic procedures. (http://www.manhattanpharma.com)
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Manhattan Pharmaceutical’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “expects,” “plans,” “believes,” “intends,” and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Manhattan’s development efforts relating to Oleoyl-estrone and its other product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Manhattan’s product candidates, including Oleoyl- estrone, the risk that the results of clinical trials may not support Manhattan’s claims, Manhattan’s reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2005. Manhattan assumes no obligation to update these statements, except as required by law.
Contact: Michelle Carroll Corporate Communications Manhattan Pharmaceuticals, Inc. 212/582-3950 Thomas Redington Redington, Inc. 203/222-7399 212/926-1733
Manhattan Pharmaceuticals, Inc.
CONTACT: Michelle Carroll, Corporate Communications of ManhattanPharmaceuticals, Inc., +1-212-582-3950 or Thomas Redington of Redington,Inc., for Manhattan Pharmaceuticals, +1-203-222-7399 or +1-212-926-1733
Web site: http://www.manhattanpharma.com/
