Oleoyl estrone in Phase Ib Trial
May 4, 2005 - 9:51:00 PM
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"We are pleased that OE's clinical development is proceeding according to our anticipated timeline. This Phase I trial will provide needed additional information about OE's tolerability and move us closer to securing the approvals necessary to bring this treatment to a patient population clearly in need of an alternative to the current therapeutics."
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By Manhattan Pharmaceuticals, Inc.,
[RxPG] Manhattan Pharmaceuticals, Inc. ("Manhattan" OTCBB: MHTT), has concluded its Phase Ia trial and begun patient dosing in the Phase Ib trial to evaluate the safety and tolerability of defined doses of orally administered Oleoyl estrone (OE) in obese adults. Like the Phase Ia trial, the Phase Ib trial will be conducted in Basel, Switzerland under Swiss Medic Approval.
The Phase Ia trial, conducted with the approval of the U.S. Food & Drug Administration (FDA) and SwissMedic, the Swiss regulatory authority, was a single-dose, dose-escalation trial that evaluated six cohorts of six patients, randomized 2:1 study drug to placebo. Manhattan is currently reviewing and analyzing the results of the trial, which will ultimately be used to obtain approval to move forward with Phase II studies.
The recently commenced Phase Ib trial is a repeat-dose, dose-escalation trial that will evaluate four cohorts of six patients each, randomized 2:1 study drug to placebo. Results from this study will also be used, in conjunction with extensive preclinical work, to establish the protocol and obtain approval from the US FDA to begin Phase II clinical trials.
"We are pleased that OE's clinical development is proceeding according to our anticipated timeline," said Douglas Abel, CEO of Manhattan Pharmaceuticals. "This Phase I trial will provide needed additional information about OE's tolerability and move us closer to securing the approvals necessary to bring this treatment to a patient population clearly in need of an alternative to the current therapeutics."
Oleoyl estrone - Targeting the Obesity Epidemic
Oleoyl estrone is believed to be a signaling molecule that acts on the hypothalamus to communicate satiety. It is hypothesized that, in healthy individuals, levels of naturally occurring OE are related to the size of the body's fat stores, while in obese individuals circulating OE levels are lower than would be expected for the level of body fat. Orally administered formulations of OE has been demonstrated, in extensive preclinical animal studies, to cause significant weight loss and reduced caloric consumption without the need for dietary modifications.
In such studies, OE appears to be safe and effective without side effects or evidence of rebound weight gain after treatment was stopped. The Company believes that OE may prove to be a safe and effective treatment for obesity, representing a significant advantage over currently available anti-obesity medications.
Manhattan believes OE could help address the obesity epidemic - one of the world's top health concerns. Nearly two-thirds of the U.S. adult population is estimated to be overweight and at least half of these are clinically obese. Though there are currently two FDA approved therapeutics on the market for the long-term treatment of obesity, market penetration remains low, possibly as a result of the modest efficacy (an average of 8-10% weight loss in the first year), and side effects reported with use of these treatment options.
Manhattan has reported favorable, peer-reviewed preclinical safety and pharmacokinetic data regarding OE at the 2004 annual meetings of the European Congress on Obesity, and the North American Association for the Study of Obesity.
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Additional information about the news article
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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. To meet the needs of other major, underserved medical markets while lowering development risks, Manhattan Pharmaceuticals also developing PTH (1-34), a peptide believed to be a regulator of epidermal cell growth, under development for psoriasis and other dermatological conditions and Propofol Lingual Spray, a convenient, proprietary lingual spray formulation of propofol, the world's best-selling general anaesthetic, as a sedative-hypnotic for use during diagnostic and therapeutic procedures.
Forward Looking Safe Harbor Statement: 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.
Contacts
For Manhattan Pharmaceuticals:
Investor Relations Group
John Nesbett/Tom Caden
212-825-3210
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