Manhattan Pharmaceuticals Expanding Oral Oleoyl-estrone Clinical Program to Include Morbidly Obese
October 12 2006 - 9:29AM
PR Newswire (US)
Phase 2a Study to be Initiated at St. Luke's-Roosevelt Hospital,
University Hospital of Columbia University NEW YORK, Oct. 12
/PRNewswire-FirstCall/ -- Manhattan Pharmaceuticals, Inc.
(AMEX:MHA) today announced expansion of its oral Oleoyl-estrone
(OE) clinical obesity program to include the morbidly obese. A new
US Phase 2a clinical trial evaluating oral OE in morbidly obese
male subjects will be initiated in October 2006. The morbidly obese
population in the US is estimated to be 14 million people. OE is
the Company's orally administered product candidate in development
for the treatment of obesity. This single-center, Phase 2a
randomized, double-blind, placebo-controlled, parallel group study
will be conducted at St. Luke's-Roosevelt Hospital Center,
University Hospital of Columbia University College of Physicians
and Surgeons. F. Xavier Pi-Sunyer, MD, will serve as Principal
Investigator. Approximately 24 morbidly obese male subjects with a
body mass index (BMI) of 40-55 will be randomized into three
treatment groups to evaluate the safety and efficacy of 10mg or
30mg of oral OE compared to placebo given once daily for 30 days.
Subjects will be evaluated at Days 1, 15, and 30. A final follow-up
visit will also occur at Day 60, 30 days after the final dose.
Morbidly obese males are considered to be the most at risk segment
of the obese population. Published studies have indicated that
morbidly obese males have a mortality rate higher than the general,
non-obese population and a higher mortality rate than morbidly
obese women. Morbidly obese males are also at significantly higher
risk for other life threatening conditions including cardiovascular
disease, coronary heart disease, and unexplained cardiac arrest.
This new clinical study will be conducted in parallel with
Manhattan Pharmaceuticals' currently ongoing, Swiss Phase 2a study,
designed to evaluate the safety, preliminary efficacy and
pharmacokinetics of two, 14-day cycles of escalating oral doses of
OE in both male and female obese adult subjects with BMIs of less
than 40. "This new study marks significant progress in the clinical
advancement of OE for the treatment of obesity, and allows us to
gather meaningful data in another distinct, high risk, patient
population, the morbidly obese" said Alan G. Harris, MD, PhD,
Manhattan's chief medical officer. 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. About
Morbid Obesity Morbid obesity (also referred to as clinically
severe obesity or extreme obesity) is defined as having a BMI of 40
or more. According to the American Obesity Association, the
morbidity and mortality risk from being overweight is proportional
to its degree. Individuals with morbid obesity, therefore, have the
highest risk for developing numerous illnesses that often reduce
mobility and quality of life due to their excess weight. In
particular, cardiovascular disease, type 2 diabetes, gallbladder
disease, osteoarthritis and sleep apnea have been found to increase
concurrently with higher BMI. Premature death has also been found
in individuals with morbid obesity. The last published figures from
the US Centers for Disease Control and Prevention indicate the
morbid obese population in the US is estimated to be 14 million
people (or 4.7% of the US population). About F. Xavier Pi-Sunyer,
MD F. Xavier Pi-Sunyer, MD, MPH is Professor of Medicine at
Columbia University College of Physicians and Surgeons and
Professor of Applied Physiology at Columbia Teachers College, both
in New York City. At St. Luke's-Roosevelt Hospital Center he serves
as Chief of Endocrinology, Diabetes, and Nutrition, and is Director
of the New York Obesity Research Center. Dr. Pi-Sunyer is also a
Senior Attending Physician at St. Luke's- Roosevelt Hospital and
New York-Presbyterian Hospital. 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 Manhattan Pharmaceuticals is also developing PTH (1-34), a
peptide believed to be a regulator of epidermal cell growth, for
the treatment of 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 press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements involve risks and uncertainties that could
cause Manhattan Pharmaceutical's actual results to differ
materially from the anticipated results and expectations expressed
in these forward-looking statements. These statements are often,
but not always, made through the use of words or phrases such as
"anticipates," "expects," "plans," "believes," "intends," and
similar words or phrases. These statements are based on current
expectations, forecasts and assumptions that are subject to risks
and uncertainties, which could cause actual outcomes and results to
differ materially from these statements. Among other things, there
can be no assurances that any of Manhattan's development efforts
relating to Oleoyl-estrone and its other product candidates will be
successful. Other risks that may affect forward-looking information
contained in this press release include the possibility of being
unable to obtain regulatory approval of Manhattan's product
candidates, including Oleoyl- estrone, the risk that the results of
clinical trials may not support Manhattan's claims, Manhattan's
reliance on third-party researchers to develop its product
candidates, and its lack of experience in developing and
commercializing pharmaceutical products. Additional risks are
described in the company's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2005. Manhattan assumes no obligation to update
these statements, except as required by law. Contact: Michelle
Carroll Corporate Communications Manhattan Pharmaceuticals, Inc.
212/582-3950 Thomas Redington Redington, Inc. 203/222-7399
212/926-1733 DATASOURCE: Manhattan Pharmaceuticals, Inc. CONTACT:
Michelle Carroll, Corporate Communications of Manhattan
Pharmaceuticals, Inc., +1-212-582-3950; or Thomas Redington of
Redington, Inc., +1-203-222-7399, or +1-212-926-1733, for Manhattan
Pharmaceuticals, Inc. Web site: http://www.manhattanpharma.com/
Copyright
Manhattan Pharmaceuticals (AMEX:MHA)
Historical Stock Chart
From Sep 2024 to Oct 2024
Manhattan Pharmaceuticals (AMEX:MHA)
Historical Stock Chart
From Oct 2023 to Oct 2024