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Manhattan Pharmaceuticals Granted FDA Approval to Initiate Phase I Clinical Trials for Oleoyl Estrone; Phase I Trial Expected to Begin in First Quarter 2005

Posted on: Thursday, 20 January 2005, 15:00 CST

The United States Food and Drug Administration (FDA) has accepted an Investigational New Drug Application (IND) from Manhattan Pharmaceuticals, Inc. ("Manhattan")(OTCBB:MHTT), for the human clinical testing of its orally administered obesity therapeutic, Oleoyl estrone (OE).

This IND allowance moves Manhattan forward into the next stage of OE's development and was granted on the preclinical chemistry, manufacturing, and safety data submitted to the FDA by the Company.

Manhattan expects to commence a Phase I clinical trial in Switzerland in the first quarter of 2005. The Company previously announced approval by the Swiss governmental medical regulatory authority, SwissMedic, to initiate human trials. This double-blinded, placebo controlled trial is designed to evaluate the safety and tolerability of defined doses of orally administered Oleoyl estrone in obese adults.

In November 2003, Manhattan announced the first peer reviewed publication reporting human physiologic responses to OE, including marked weight loss, during 27 months of oral administration. More recently, Company scientists reported favorable preclinical toxicology data for OE at the 13th Annual Meeting of the European Congress on Obesity in May 2004 and additional pharmacology data at the North American Association for the Study of Obesity Annual Meeting in November of 2004.

About Oleoyl estrone

Oleoyl estrone is Manhattan Pharmaceuticals, Inc.'s lead product candidate. It is an orally administered small molecule shown, in extensive preclinical animal studies, to cause significant weight loss without the need for dietary modifications. In such studies, OE appears to be safe and effective with no evidence of rebound weight gain after treatment has been discontinued. OE may prove to be a safe and effective treatment for obesity, representing a significant advantage over currently available anti-obesity medications.

About Manhattan Pharmaceuticals, Inc.

Manhattan Pharmaceuticals, Inc. (http://www.manhattanpharma.com/), 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 Oleoyl estrone, an orally administered novel therapeutic for weight loss. The Company is also developing 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.

Certain statements contained in this news release that are forward-looking in nature are based on the current beliefs and assumptions of our management. When used in this press release, the words "may,""could,""should,""anticipate,""believe,""estimate,""expect,""intend,""plan,""predict," and similar expressions and their variants may be used to identify forward-looking statements. 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, 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 of clinical trials, the FDA review process and other governmental regulation, our pharmaceutical collaborator's ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission.

Source: Business Wire

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