Manhattan Pharmaceuticals' Topical Psoriasis Treatment in Phase IIa Trial
28 Diciembre 2005 - 10:25AM
PR Newswire (US)
NEW YORK, Dec. 28 /PRNewswire-FirstCall/ -- Manhattan
Pharmaceuticals, Inc. (AMEX:MHA) reported that a Phase IIa study
has been initiated with PTH (1-34), its experimental product for
the topical treatment of psoriasis. The investigator-initiated
study is being conducted at Boston University Medical Center. The
double-blinded, placebo-controlled trial will treat 40 adult
volunteers up to age 80 with daily application of a placebo and two
strengths of PTH (1-34), all delivered in the proprietary
Novasome(R) base developed by IGI, Inc. (AMEX:IG). The aim of the
study is to determine the therapeutic efficacy and safety of PTH
(1-34) (a parathyroid hormone-related peptide analog) for the
treatment of adult patients with psoriatic lesions. Topical PTH
(1-34) is based on a naturally occurring protein in skin and hair
follicles that serves to regulate the growth of skin cells. When
applied to psoriatic lesions in an earlier Phase I/II clinical
trial, PTH (1-34) restored the normal development and migration of
skin cells, preventing cell build-up and the formation of plaques.
Because PTH (1-34) is the active ingredient in a currently approved
injectable product for osteoporosis, Manhattan Pharmaceuticals
expects to be able to seek approval of its topical form of the drug
under the provisions of a 505(b)(2) regulatory submission, a form
of New Drug Application (NDA) that relies on the FDA's previous
findings in approved NDAs and published literature. This limits new
systemic safety data requirements. Psoriasis affects nearly 4.5
million Americans today, with 15-25 percent of those patients
developing a moderate to severe form of the disease. Psoriasis
patients in the US seeking treatment account for nearly 2.4 million
dermatology visits a year, at a total cost of $3 billion. Current
topical treatments for psoriasis range from traditional tar salve,
which has limited efficacy, to tazarotene gel, which commonly
causes localized itching and burning. Topical corticosteroids are a
mainstay in the treatment of localized psoriasis; however, they are
not recommended for long-term use and can have significant side
effects and intolerability issues. The most widely prescribed
non-steroidal compound is a topical form of calcipotriene (brand
name Dovonex(R)), which has been owned and promoted by a variety of
companies since its introduction in 1994 and currently generates
about $140 million in US product sales and significant additional
revenue worldwide. PTH (1-34)'s early data shows a potentially
stronger product profile than Dovonex(R). What Is Psoriasis?
Psoriasis is a common, chronic, immune-mediated skin disease of
unknown cause that results in the overproduction and abnormally
rapid migration of skin cells to the skin's surface. The skin is
unable to shed these cells quickly enough, and the cells then
accumulate in dry, thick patches called plaques. Plaques may appear
anywhere in the body and can irritate the skin, causing mild to
severe discomfort or disability. About Manhattan Pharmaceuticals,
Inc. Manhattan Pharmaceuticals, Inc.
(http://www.manhattanpharma.com/), 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 weight loss. To
meet the needs of other major, underserved medical markets while
lowering development risks, Manhattan Pharmaceuticals 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. About IGI, Inc.
IGI, Inc. is a company committed to growth by applying proprietary
technologies to achieve cost-effective solutions for varied
customer needs. IGI offers the patented Novasome(R) lipid vesicle
encapsulation technology which contributes value-added qualities to
cosmetics, skin care products, dermatological formulations and
other consumer products, providing improved dermal absorption, low
potential for irritations, controlled and sustained release as well
as improved stability. IGI has licensed Novasome(R) lipid vesicle
encapsulation technology to leading global dermatological and skin
care companies including Johnson & Johnson Consumer Products,
Inc., Estee Lauder Companies, Chattem Inc., Genesis Pharmaceutical,
Inc. and Apollo Pharmaceutical, Inc., and recently sub-licensed the
rights to obtain FDA approval for and market IGI's PTH (1-34)
compound using Novasome(R) lipid vesicle encapsulation technology
for psoriasis, which is slated for Phase II clinical trials, to
Tarpan Therapeutics, Inc., which was acquired by Manhattan
Pharmaceuticals in April 2005. IGI is also exploring the licensing
of the topical PTH (7-34) compound for the prevention/treatment of
chemotherapy induced-alopecia in patients undergoing chemotherapy.
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, 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 of clinical trials,
the FDA review process and other governmental regulation, our
pharmaceutical collaborator's ability to successfully develop and
commercialize drug candidates, competition from other
pharmaceutical companies, product pricing and third party
reimbursement, and other factors described in our filings with the
Securities and Exchange Commission. Contact: 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 of Manhattan
Pharmaceuticals, Inc., +1-212-582-3950, or Thomas Redington of
Redington, Inc., +1-203-222-7399, or +1-212-926-1733 Web site:
http://www.manhattanpharma.com/
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