Manhattan Pharmaceuticals Successfully Completes Dosing Portion of Two Phase 2a Clinical Trials of Oral Oleoyl-estrone for Obesi
May 10 2007 - 9:29AM
PR Newswire (US)
Results For Both Trials Expected Mid 2007 NEW YORK, May 10
/PRNewswire-FirstCall/ -- Manhattan Pharmaceuticals, Inc.
(AMEX:MHA) today announced it has successfully completed patient
dosing in two separate, ongoing Phase 2a clinical trials of oral
Oleoyl-estrone (OE). The first trial is evaluating OE for the
treatment of common obesity and the second trial is evaluating OE
for treatment of morbid obesity. Both trials include a post-dosing
follow up period. Study completion and data analysis will begin
after the final follow up visit. Data analysis is scheduled to be
completed in July 2007. The common obesity clinical trial is a
multi-center, international, randomized, double-blind,
placebo-controlled, parallel group study of OE in 100 patients.
This study is designed to evaluate obese adult subjects with a body
mass index (BMI) of 27-38.9. The subjects were randomized into one
of four treatment groups to evaluate the safety, preliminary
efficacy, and pharmacokinetics of two 14-day dosing cycles of 5mg,
10mg, or 20mg of oral OE compared to placebo given once daily
during each dosing cycle. The dosing cycles are each followed by a
28-day treatment free evaluation period, and then a final follow-up
visit takes place at Day 113, 57 days after administrations of the
final dose. The morbid obesity clinical trial is a multi-center,
randomized, double- blind, placebo-controlled parallel group study
of OE in 24 morbidly obese (BMI 40-55) male subjects. The subjects
were 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. A final follow-up visit will also occur at
day 60, 30 days after administration of the final dose. The company
believes there are currently no effective oral therapies available
for the treatment of morbid obesity. F. Xavier Pi-Sunyer, MD, of
St. Luke's-Roosevelt Hospital Center, University Hospital of
Columbia University College of Physicians and Surgeons is serving
as Principal Investigator. In addition to safety and tolerability,
both Phase 2a studies are also designed to evaluate weight loss,
maintenance of weight loss, and other therapeutic outcomes. OE is
an orally administered, synthetic form of oleoyl-estrone, a
molecule that exists naturally in the body. Based on extensive
preclinical studies, it is believed to work by a dual mechanism of
action. Centrally, OE appears to act at the brain's 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 adipose tissue and allows skeletal
muscle to use fat as an alternate energy source. About Common and
Morbid Obesity The US Centers for Disease Control and Prevention
estimate there are approximately 70 million obese Americans, and
according to the World Health Organization, there are nearly 300
million obese adults worldwide. Obesity is a major health risk and
a burden on the US healthcare system. It increases the risk of type
2 diabetes, heart disease, hypertension, gall bladder disease,
stroke, sleep apnea, some forms of cancer, and many other serious
health conditions. In 2000, the economic cost of obesity in the US
was estimated to be over $117 billion and a significant portion of
that was paid my Medicare and Medicaid. Analysts currently estimate
that the market for obesity therapeutics in the US alone could be
approximately $10 billion, and considerably more worldwide. Morbid
obesity, which is considered to be the fasting growing segment of
the obese population, is defined as having a body mass index of 40
or more. 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. Today, bariatric surgery (gastric
bypass, vertical banded gastroplasty, and laparoscopic gastric
banding - LAP-BAND(R)) represents one of the few treatment options
available to morbidly obese patients. While these procedures have
been shown effective in decreasing body weight, they are costly and
carry significant risk. There are currently no oral therapies
available for the treatment of morbid obesity. About Manhattan
Pharmaceuticals, Inc. Manhattan Pharmaceuticals, Inc., (AMEX:MHA)
is a pharmaceutical company developing novel, high-value drug
candidates primarily in the areas of endocrine/metabolic disease
and dermatologic/immunologic disorders. With a pipeline consisting
of five clinical-stage product candidates, Manhattan
Pharmaceuticals is developing potential therapeutics for large,
underserved patient populations seeking superior treatments for
conditions including common obesity, morbid obesity, psoriasis, and
atopic dermatitis (eczema). 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 forward-looking statements include
without limitation, statements regarding the timing, progress and
results of the completion of clinical trials and data analysis
relating to Oleoyl-estrone. 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, 2006. Manhattan assumes no obligation to update
these statements, except as required by law. Contact: Manhattan
Pharmaceuticals, Inc. Corporate Communications Michelle Carroll
212/582-3950 Redington, Inc. Thomas Redington 203/222-7399
212/926-1733 DATASOURCE: Manhattan Pharmaceuticals, Inc. CONTACT:
Michelle Carroll, Corporate Communications, 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.
Copyright
Manhattan Pharmaceuticals (AMEX:MHA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Manhattan Pharmaceuticals (AMEX:MHA)
Historical Stock Chart
From Sep 2023 to Sep 2024