Manhattan Pharmaceuticals Receives SwissMedic's Approval to Commence Phase IIa Trial With OE, Its Oral Obesity Drug Candidate
May 16 2006 - 9:02AM
PR Newswire (US)
NEW YORK, May 16 /PRNewswire-FirstCall/ -- Manhattan
Pharmaceuticals, Inc. (AMEX:MHA) today reported receipt of Swiss
regulatory approval to commence its Phase IIa study with oral
Oleoyl-estrone (OE), the company's drug candidate for the treatment
of obesity. The single center, Phase IIa study is a randomized,
double-blind, placebo-controlled, parallel group study designed to
evaluate the safety, preliminary efficacy, and pharmacokinetics of
two 14-day dosing cycles in obese adult subjects. 100 subjects will
be randomly enrolled in one of four treatment groups. Dose levels
of OE will be placebo, 5, 10, or 20 mg taken once daily. Each
14-day dosing cycle will be followed by a 28-day treatment free
evaluation period. "This approval marks a significant achievement
in the clinical development program with oral Oleoyl-estrone," said
Douglas Abel, Manhattan's CEO. "Given the encouraging early trial
results and the large unmet medical need in obesity, we are very
pleased to be able to proceed toward patient recruitment and
enrollment." "Oleoyl-estrone is a promising drug candidate and is
thought to work both centrally and peripherally," said Alan G.
Harris, MD, PhD, Manhattan's chief medical officer. "Centrally, it
appears to reset the body's ponderostat, the 'food control center'
located in the hypothalamus of the brain that detects and
integrates signals controlling appetite and metabolic behavior.
Peripherally, OE appears to cause reduced storage of fat in 'white
fat' tissue and allows skeletal muscle to use fat as an alternate
energy source." OE is an orally administered, synthetic form of
Oleoyl-estrone, a molecule that exists naturally in the body.
Results of the Phase I clinical trials with OE, reported in October
2005, showed the compound was well tolerated. Subjects in the Phase
Ib study experienced weight loss as well as beneficial changes in
blood glucose and cholesterol levels. There was also evidence of OE
offering the potential for sustained weight loss after dosing with
OE stopped. Clinical laboratory findings included reversible,
dose-dependent elevations in estrone and estradiol levels, as well
as reductions in testosterone levels. Obesity is rapidly becoming a
global epidemic. The US 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 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, 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 of Manhattan
Pharmaceuticals, Inc., +1-212-582-3950; or Thomas Redington of
Redington, Inc., +1-203-222-7399, or +1-212-926-1733 Web site:
http://www.manhattanpharma.com/
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