NEW YORK, Dec. 16, 2010 (GLOBE NEWSWIRE) -- Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.
In this randomized, double-blind, placebo-controlled, crossover design study, 18 subjects with essential tremor received single oral doses of AST-915. Primary and secondary outcome measures included the effect on tremor power using accelerometry to test the central tremor component at various time-points after treatment. Safety, pharmacokinetic data and other efficacy measures were also evaluated. The study was conducted at The National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) under a CRADA agreement between the NIH and Ariston Pharmaceuticals, Inc., a wholly owned subsidiary of Manhattan Pharmaceuticals, Inc.
AST-915 was well tolerated with non-serious adverse events being evenly distributed between active and placebo treatments and two observed serious adverse events being unrelated to the study drug.
While a statistically significant effect on tremor power was not evident 80 minutes after administration of AST-915 (defined as the primary endpoint timeframe), statistically significant reductions in tremor were evident at several later time-points up to 300 minutes, the latest time-point measured following administration of AST-915. Further analysis, conducted using each subject as its own control, also demonstrated statistically significant lower tremor amplitudes in favor of AST-915 compared to placebo. Additional analysis continues to examine other secondary endpoints.
"This early positive data in subjects with essential tremor clearly demonstrates human proof of concept and indicates a need to explore the effect of higher doses and longer term administration of AST-915," said Malcolm Morville, PhD, Director of Manhattan Pharmaceuticals, Inc.
The NIH intends to submit an abstract to the 15th International Congress of Parkinson's Disease and Movement Disorders taking place in Toronto, Ontario in June 2011. Complete study findings are expected to be disclosed at this and other scientific meetings, and by submission to scientific journals.
About Essential Tremor
Essential tremor is a common movement disorder that is characterized by involuntary shaking of the hands, arms, head, voice and upper body. The most disabling tremors occur during voluntary movement affecting common skills such as writing, eating and drinking and body care. According to the International Essential Tremor Foundation, an estimated 10 million Americans have essential tremor. The condition is most common among people over 60, but it also occurs in children, adolescents and the middle-aged. There is no curative treatment for essential tremor and current therapy is inadequately effective in a large portion of patients and/or limited by side effects.
About The National Institute of Neurological Disorders and Stroke (NINDS)
The mission of the NINDS is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world. For more information about NINDS, call (800) 352-9424 or visit the NINDS Web site at .
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc. is a specialty healthcare product company focused on the development and commercialization of innovative treatments for underserved patient populations. The company is currently focused on two lead programs: AST-726, a nasally delivered vitamin B12 remediation treatment, and Hedrin®, a novel, non-insecticide treatment for pediculosis (head lice), which is being developed through a joint venture with Nordic Biotech. The company is also studying AST-915 for the treatment of essential tremor and a topical GEL product which may be commercialized as an OTC treatment for mild psoriasis.
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 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 "intends," "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, that any clinical study will be completed or will return positive results. Other risks that may affect forward-looking information contained in this press release include the company's extremely limited capital resources, the risk that the results of clinical trials may not support the company's or its joint venture'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-K for the year ended December 31, 2009. Manhattan Pharmaceuticals, Inc. assumes no obligation to update these statements, whether as a result of new information, future events, or otherwise, except as required by law.
CONTACT: Manhattan Pharmaceuticals, Inc. Michelle Y. Carroll, Vice President, Corporate Development (212) 582-3950