MHA Manhattan Pharmaceuticals

NEW YORK, June 29 /PRNewswire-FirstCall/ -- Manhattan Pharmaceuticals, Inc. (AMEX:MHA) today announced that it commenced dosing the first group of patients in its Phase IIa clinical trial of oral Oleoyl-estrone (OE), the company's novel drug candidate for the treatment of obesity. Patient recruitment is ongoing. The randomized, double-blind, placebo-controlled, parallel group Phase IIa study of OE is designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of the compound in obese adult subjects. Dose levels of OE will be placebo, 5, 10, and 20 mg daily. Manhattan expects that 100 subjects will be randomly enrolled into one of these four treatment groups that comprise this Phase IIa trial. In addition to safety and tolerability, this Phase IIa study is also designed to further evaluate weight loss, maintenance of weight loss, and other therapeutic outcomes. "This is a major step forward in the development of OE and emphasizes the excellent progress being made with the clinical program," said Alan Harris, MD, PhD, Manhattan Pharmaceuticals' chief medical officer. "Oleoyl-estrone is a promising drug candidate thought to work both centrally and peripherally." 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. Obesity is rapidly becoming a global epidemic. The U.S. Centers for Disease Control reports that 65 percent of Americans are overweight and 30 percent are obese. The number of clinically obese Americans is expected to grow from 73 million currently to 94 million during the next 5-6 years. Currently marketed obesity treatments have not been shown to be particularly effective in accomplishing sustained weight loss. Even if weight loss is achieved, current obesity treatments do not reduce the likelihood of regain of lost weight once treatment has stopped. Most marketed weight loss therapeutics also cause unwanted side effects. 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. To meet the needs of other major, underserved medical markets while lowering development risks, Manhattan Pharmaceuticals is also developing PTH (1-34), a peptide believed to be a regulator of epidermal cell growth, for 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 news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, the risk that the results of preclinical studies may not be indicative of results from clinical trials, as well as risks and uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion and results of clinical trials, including clinical trials involving oleoyl-estrone, the FDA review process and other governmental regulation, our pharmaceutical collaborator's ability to successfully develop and commercialize drug candidates, issues relating to drug formulation and manufacturing, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2005. The Company assumes no obligation to update these statements, except as required by law. Nicholas J. Rossettos, CPA Chief Financial Officer Manhattan Pharmaceuticals, Inc. 212/582 3950 Thomas Redington Redington, Inc. 203/222-7399 212/926-1733 DATASOURCE: Manhattan Pharmaceuticals, Inc. CONTACT: Nicholas J. Rossettos, CPA, Chief Financial Officer, Manhattan Pharmaceuticals, Inc., +1-212-582-3950; Thomas Redington, Redington, Inc., +1-203-222-7399, +1-212-926-1733 Web site: http://www.manhattanpharma.com/

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