SOURCE: Neuro-Hitech

July 18, 2006 10:10 ET

Cumulative Research Indicates Huperzine A Offers Potential Advantages Over AChE Inhibitors Used in U.S. to Treat Alzheimer's, Neuro-Hitech Study Finds

Found to Be Safe and Well Tolerated in Cognitively Normal Older Adults, Phase II Study Continuing

NEW YORK, NY -- (MARKET WIRE) -- July 18, 2006 -- Cumulative research on the development of huperzine A -- an alkaloid extract of the plant Huperzia serrata -- as a treatment for Alzheimer's shows it may have advantages over other AChE inhibitors being used in the U.S. to treat Alzheimer's Disease (AD), according to early results in a new study from Neuro-Hitech (OTCBB: NHPI), a biopharmaceutical company focused on the development and commercialization of next-generation therapies against proven targets for neurodegenerative diseases. Preclinical studies suggest that the potential advantages of huperzine A include higher blood-brain-barrier penetration, better tolerability and multiple mechanisms of action, including both AChE and NMDA antagonism. Antioxidant and neuroprotective properties may also be useful as a disease-modifying treatment. A Phase II study is currently underway.

The findings were presented at the 10th International Conference on Alzheimer's Disease and Related Disorders (ICAD) Conference in Madrid, by Dr. Paul S. Aisen, Vice Chair of the Department of Neurology and the Director of the Memory Disorders Program at Georgetown University School of Medicine, who also serves as the Phase II trial's project director.

Collaborating with the Alzheimer's Disease Cooperative Study, the National Institutes of Health and Georgetown University Medical Center, Neuro-Hitech has completed two U.S. Phase I studies for huperzine A and is currently conducting Phase II clinical trials. In a series of two four-week Phase I dose-escalation clinical trials, huperzine A was found to be safe and well tolerated in cognitively normal older (65-79 years) subjects. Even at doses up to 800 micro-g per day, side effects were rated as mild.

In the current Phase II study, the company is evaluating 150 participants at 28 locations in a double-blind, placebo-controlled therapeutic trial to determine whether natural huperzine A improves cognitive function in individuals with AD. Participants are being randomly assigned to three equal groups, allowing comparison of huperzine A 200 micro-g bid, huperzine A 400 micro-g bid and a placebo. This study's endpoints will include not only assessments of cognitive function, but also a global clinical impression of change, activities of daily living and neuropsychiatric status. At the conclusion of the 24-week study, Neuro-Hitech will provide huperzine A on a complimentary basis to subjects who wish to participate in a six-month, open-label extension phase of the research.

"Although no registration trials have yet to be conducted in the U.S., huperzine A has been extensively studied in clinical trials in China, where it's been prescribed with efficacy and safety for several years," said Ruben Seltzer, CEO of Neuro-Hitech. "Our own research indicates that huperzine A compares favorably in efficacy and safety to other AChE products currently on the market, and we plan to make huperzine A available in both oral and transdermal form."

Background

Huperzine A, an alkaloid extract of the plant Huperzia serrata, is a component of a traditional Chinese herbal medicine, Qian Ceng Ta that is used to treat fever and inflammation. During the 1980s, scientists in China determined that huperzine A was a potent inhibitor of acetylcholinesterase (AChE) (Wang et. al. 1986), a finding that has been confirmed repeatedly (Ashani et al 1992; Saxena et al 1994). The growing use of huperzine A by AD and non-AD individuals in the U.S. has increased the urgency of conducting controlled clinical trials to determine its safety and efficacy. This is the first controlled study of huperzine A being conducted outside of China.

About Neuro-Hitech, Inc.

Neuro-Hitech (www.neurohitech.com) is focused specifically on the development and commercialization of next-generation therapies against proven targets for neurodegenerative diseases. The company's product offering, Huperzine A and its analogues, is being tested for efficacy in the treatment of Alzheimer's disease, as well as vascular dementia, mild cognitive impairment and myasthenia gravis. The company is also researching the effectiveness of Huperzine A as a pre-treatment for protection against nerve gas (organophosphate poisoning). Neuro-Hitech plans to make Huperzine A available in both oral and transdermal forms of drug delivery.

This release contains forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.

Contact Information

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