Jun 11 2007, 8:31 AM EST
News source: Business Wire
Neuro-Hitech, Inc. (NASDAQ: NHPI) today announced that its U.S. Phase II clinical trial of Huperzine A is fully enrolled. In December 2006, a decision was made to increase enrollment from the original target of 150 by an additional 60 patients. Enrollment was recently concluded with 210 subjects at 35 trial sites throughout the U.S.
This Phase II clinical trial of Huperzine A is a randomized, placebo-controlled study designed to evaluate the compound's safety and efficacy in improving cognitive function of Alzheimer's patients. The study design used a three parallel-arm approach, meaning that patients are randomly assigned into one of three equally sized groups. Each group is administered either Huperzine A twice daily in an escalating 200mcg dose, Huperzine A twice daily in an escalating 400 mcg dose, or a placebo. The study is 24 weeks in length with the primary end-point being the ADAScog score at 16 weeks. After 24 weeks, patients are offered the option to participate in an open label extension for up to a total of 32 weeks while placebo patients are offered active drug at 16 weeks.
The Phase II trial of Huperzine A has been supported by some of the notable researchers and organizations in the Alzheimer's disease community. Dr. Paul Aisen, Professor of Neurology and Medicine at Georgetown University and one of the first clinicians to conduct formal trials in Alzheimer's disease, is the lead investigator for this trial. The National Institutes of Health (NIH) and the Alzheimer's Disease Cooperative Study (ADCS) have also been influential in the conduct of this important clinical trial.
Mr. Reuben Seltzer, Chief Executive Officer of Neuro-Hitech commented, "The entire management team is pleased that enrollment has closed in the Phase II trial of Huperzine A. Because of support from Dr. Paul Aisen, the National Institute of Health, the Alzheimer's Disease Cooperative Study and many others, this trial has been executed flawlessly."
About Neuro-Hitech, Inc.
Neuro-Hitech, Inc. is a New York-based biopharmaceutical company focused specifically on the development and commercialization of next-generation therapies against proven targets for neurodegenerative diseases. Our lead product candidate, Huperzine A, is being clinically tested for efficacy and safety in the treatment of Alzheimer's disease. Huperzine A has been shown to protect nerve cell death and have a longer duration of acetylcholinesterase inhibitory action relative to other cholinesterase inhibitors. In addition to Huperzine A, Neuro-Hitech has two major preclinical development programs. One consists of a portfolio of second-generation anti-amyloid compounds that target A-beta and Tau proteins. The other targets the development of a novel series of compounds designed to treat (anti-ictogenic) and prevent (anti-epileptogenic) epilepsy.
Find more information about Neuro-Hitech online at www.neurohitech.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements (as defined in Section 27A of the Securities Act and Section 21E of the Exchange Act). To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "projects" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include those outlined in "Risk Factors" found within our Annual Report on Form 10-KSB and include, without
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