NEW YORK, April 10, 2008 (PRIME NEWSWIRE) -- Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced today that it has completed patient enrollment in its ongoing Phase 2a clinical study of Topical PTH (1-34). This randomized, double-blind, vehicle-controlled, parallel group study is designed to evaluate safety and preliminary efficacy of Topical PTH (1-34) for the treatment of psoriasis. The study randomized 61 patients into three treatment groups (two dose levels of Topical PTH (1-34) and one vehicle only group) for an 8-week treatment period at four U.S. clinical trial sites. The vehicle used in this study is the topical product without the active ingredient, PTH (1-34). The company expects to announce the results of this study in summer 2008.
"We are pleased to have completed enrollment in this Phase 2a study on schedule," stated Douglas Abel, president and chief executive officer of Manhattan Pharmaceuticals, Inc. "We look forward to completing the study and announcing results later this year."
A previously completed Phase 1/2, double-blind, placebo-controlled study was conducted under a physician investigational new drug (IND) application at Boston University Medical Center with Topical PTH (1-34) in patients with psoriasis. A 67% global improvement was observed in the trial patients with 60% of participants experiencing a complete clearing of their psoriasis lesions and 85% experiencing at least partial clearing. In this study, Topical PTH (1-34) treatment was well tolerated with no adverse effects reported.
About Topical PTH (1-34)
It is believed that PTH (1-34) is an agonist that mimics a natural protein responsible for regulating the growth of skin cells. The presence of this natural protein, PTHrp, is significantly reduced in the skin of psoriasis patients leading to skin cell hyperproliferation, poor differentiation of skin cells, and ultimately, the accumulation of dry thick patches of skin (plaques). Acting in place of the absent PTHrp, it is also believed that PTH (1-34) is able to restore skin cells' normal rate of development, migration and turnover, reducing cell accumulation and the formation of plaques.
About Psoriasis
Psoriasis is a common, chronic, immune-mediated disease that results in the over-production of skin cells. In healthy skin, immature skin cells migrate from the lowest layer of the epidermis to the skin's surface over a period of 28-30 days. In psoriasis, these cells reproduce at an extremely accelerated rate and advance to the surface in only 7 days. This results in a build up of excess, poorly differentiated skin cells that accumulate in dry, thick patches known as plaques. These plaques can appear anywhere on the body resulting in skin irritation and disability.
According to the National Psoriasis Foundation nearly 2% of the worldwide population, including approximately 4.5 million Americans, suffers from psoriasis. In the U.S., psoriasis patients are responsible for nearly 2.4 million visits to dermatologists each year at an annual cost of nearly $3 billion. Manhattan Pharmaceuticals estimates the U.S. topical psoriasis therapeutics market to be approximately $400-500 million, with the market throughout the rest of the world in the same range.
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc. is a specialty pharmaceutical company that acquires and develops novel, high-value drug candidates primarily for the treatment of dermatologic and immune disorders. With a pipeline consisting of four clinical stage product candidates, the company is currently developing Hedrin(tm), a novel, non-insecticide treatment for pediculosis (head lice); Topical PTH (1-34) for the treatment of psoriasis; Altoderm(tm) (topical cromolyn sodium) for the treatment of pruritus associated with dermatologic conditions including atopic dermatitis; and Altolyn(tm) (oral tablet cromolyn sodium) for the treatment of mastocytosis. (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, including, among others, those relating to our Phase 2a study of Topical PTH (1-34) for psoriasis. Such statements involve risks and uncertainties that could cause Manhattan Pharmaceuticals, Inc.'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, Inc.'s 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, Inc.'s development efforts relating to its PTH (1-34), Hedrin(tm), Altoderm(tm), or Altolyn(tm) product candidates, or any future product candidates, will be successful, or that Manhattan Pharmaceuticals, Inc. will be able to out-license its discontinued programs to other companies on terms acceptable to Manhattan Pharmaceuticals, Inc. or at all. Other risks that may affect forward-looking information contained in this press release include, without limitation, the company's extremely limited capital resources, the possibility of being unable to obtain regulatory approval of Manhattan Pharmaceuticals, Inc.'s 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, 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-K for the year ended December 31, 2007. Manhattan Pharmaceuticals, Inc. assumes no obligation to update the information contained in this press release, whether as a result of new information, future events or otherwise.