Manhattan Pharmaceuticals Doses First Patient Group In Phase IIa Trial For OE, Its Oral Obesity Drug Candidate
June 29 2006 - 10:29AM
PR Newswire (US)
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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