Full Press Release Details
Pharmaceuticals Announces Results of
2a Studies for Oral Oleoyl-estrone
YORK, NY JULY 9, 2007
Manhattan Pharmaceuticals, Inc. (AMEX: MHA) today announced results of the
company's two Phase 2a clinical trials of oral Oleoyl-estrone (OE). The results
of both randomized, double-blind, placebo-controlled studies, one in common
obesity and the other in morbid obesity, demonstrated no statistically or
clinically meaningful placebo adjusted weight loss for any of the treatment
evaluated. Based on these results, Manhattan Pharmaceuticals will discontinue
its OE programs in both common obesity and morbid obesity.
studies also showed dose-dependent increases in estrone and estradiol and
concomitant suppression of testosterone. In addition, thyroid hormone changes
were observed as well as changes in other hormones related to reproductive
function (i.e., FSH, LH, prolactin, sex hormone binding globulin). Despite
changes returning to baseline during off therapy periods they preclude
exploration of higher doses of OE.
the study results were disappointing but definitive," said Douglas Abel,
president and chief executive officer of Manhattan Pharmaceuticals. "With
all our development programs, Manhattan Pharmaceuticals is committed to the
practice of excellent science and the highest standard of clinical research
ensure both accurate outcomes and patient safety. Based on positive
preclinical data on OE, confirmatory results recently reported by Columbia
University, and the Phase 1 clinical profile, we had been encouraged regarding
the compound's potential as an effective weight loss agent. However, due
to the findings from the two Phase 2a trials, we believe it is the correct
decision to discontinue our work with OE. These well designed Phase 2a
trials produced quality data that permits us to make a clear cut decision at
early stage of the program."
forward the company intends to continue with the
advancement of its four clinical stage product candidates, and the exploration
of other opportunities in the areas of dermatology/immunology and
endocrine/metabolic disorders. The four clinical-stage product candidates
include topical PTH (1-34) for psoriasis, as well as recently-acquired
atopic dermatitis (eczema), Altolyn
mastocytosis, and Hedrin
keeping with this strategic focus, Manhattan Pharmaceuticals also announced
today that it intends to pursue appropriate out-licensing opportunities for
Propofol Lingual Spray for pre-procedural sedation.
Discussion Call and Webcast
Pharmaceuticals will hold a management discussion call and webcast to describe
the OE results in further detail, and to discuss the advancement of its four
clinical stage product candidates at 8:30 AM ET on Tuesday, July 10, 2007.
access the call, please dial 800.289.0468 (domestic) or 913.981.5517
(international) five minutes prior to the start time. A replay of the call
be available approximately 2 hours following the event and will last until
Friday, July 13, 2007 at 6:00 PM ET. To access a replay, please dial
888.203.1112 (domestic) or 719.457.0820 (international), and provide the pass
code 1451123. To access the live audio webcast please visit the "Investors &
Media" section of the company's website located at www.manhattanpharma.com.
archived webcast will be available on the website approximately 2 hours after
the event and will be available in the archive until Friday, July 13, 2007
Manhattan Pharmaceuticals, Inc.
Pharmaceuticals, Inc., (Amex: MHA) is a clinical-stage pharmaceutical company
that acquires and develops novel, high-value drug candidates primarily in the
areas of dermatologic/immunologic and endocrine/metabolic disease disorders.
With a pipeline consisting of four clinical-stage product candidates, Manhattan
Pharmaceuticals is developing potential therapeutics for large, underserved
patient populations seeking superior treatments for conditions including
psoriasis, atopic dermatitis (eczema), mastocytosis, and head lice. Please
our new corporate website at http://www.manhattanpharma.com
Regarding Forward-Looking Statements
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
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," "will," and similar words or phrases. These
statements are based on Manhattan Pharmaceuticals' current expectations,
forecasts and assumptions, which 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 Manhattan
Pharmaceuticals' development efforts relating to its PTH (1-34), Altoderm ,
Altolyn or Hedrin product candidates, or any future product candidates, will
be successful, or that Manhattan Pharmaceuticals will be able to out-license
discontinued programs to other companies on terms acceptable to Manhattan
Pharmaceuticals, or at all. 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 Pharmaceuticals' product
candidates, the risk that the results of clinical trials may not support the
company's claims, the risk that the company's product candidates may not achieve
market acceptance in North America or elsewhere, the company's reliance on
third-party researchers to develop its product candidates, availability of
patent protection, the risk that sufficient capital may not be available to
develop and commercialize the company's product candidates, and the company's
lack of experience in developing and commercializing pharmaceutical products.
Additional risks are described in the company's filings with the Securities
Exchange Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2006. Manhattan Pharmaceuticals assumes no obligation to
update these statements, whether as a result of new information, future events,
or otherwise, except as required by law.