Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
09 Juillet 2007 - 10:30PM
PR Newswire (US)
- Results Fail to Demonstrate Meaningful Placebo Adjusted Weight
Loss; Obesity Program to be Discontinued NEW YORK, July 9
/PRNewswire-FirstCall/ -- 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 arms evaluated. Based on these results,
Manhattan Pharmaceuticals will discontinue its OE programs in both
common obesity and morbid obesity. Both 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 these changes returning to baseline
during off therapy periods they preclude exploration of higher
doses of OE. "Unfortunately, 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 to
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 an early stage
of the program." Going 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 Altoderm(TM) for atopic
dermatitis (eczema), Altolyn(TM) for mastocytosis, and Hedrin(TM)
for head lice. In 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. Management Discussion Call and Webcast
Manhattan 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. To 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 will 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
http://www.manhattanpharma.com/. An 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 at
6:00 PM ET. About Manhattan Pharmaceuticals, Inc. Manhattan
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 visit our new corporate website
at http://www.manhattanpharma.com/ for more information. 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," "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(TM), Altolyn(TM) or
Hedrin(TM) product candidates, or any future product candidates,
will be successful, or that Manhattan Pharmaceuticals will be able
to out-license its 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 and 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. Contact
information Douglas Abel President & Chief Executive Officer
212.582.3950 phone DATASOURCE: Manhattan Pharmaceuticals, Inc.
CONTACT: Douglas Abel, President & Chief Executive Officer of
Manhattan Pharmaceuticals, Inc., +1-212-582-3950 Web site:
http://www.manhattanpharma.com/
Copyright
Manhattan Pharmaceuticals (AMEX:MHA)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Manhattan Pharmaceuticals (AMEX:MHA)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024