SOURCE: Neuro-Hitech

December 08, 2006 08:25 ET

Neuro-Hitech Expands Size of Clinical Trial for Use of Huperzine A in the Treatment of Alzheimer's Disease

NEW YORK, NY -- (MARKET WIRE) -- December 8, 2006 --Neuro-Hitech, Inc. (OTCBB: NHPI), a biopharmaceutical company focused on the development and commercialization of next-generation compounds against proven targets for neurodegenerative diseases, today announced that it has decided to expand the enrollment level for its Phase II clinical trial on the efficacy of Huperzine A, a highly promising second-generation acetylcholinesterase inhibitor, for people with mild to moderate Alzheimer's. The trial will be expanded by 30 to 60 participants, an increase of up to 40% from the number originally planned. The company also has earmarked an additional $2 million in funding for the study.

"The primary reason for increasing enrollment is to boost the predictive power of the study in demonstrating the effect of Huperzine A on cognitive performance," said Dr. Paul Aisen, the principal investigator of the study and professor of neurology at Georgetown University Medical Center. In addition to the inhibition of acetylcholinesterase, the mode of action of the most widely available Alzheimer's disease drugs, Neuro-Hitech's Huperzine A has other modes of action directed against other disease targets. "Another key benefit of expanded enrollment is to improve the power of secondary analyses assessing, for example, the impact of Huperzine A on behavior and function," Dr. Aisen added.

In collaboration with leading organizations in this field -- the Alzheimer's Disease Cooperative Study, the National Institutes of Health and Georgetown University Medical Center -- Neuro-Hitech has already completed two U.S. Phase I studies and reached the original enrollment goal of 150 patients in the Phase II trials of Huperzine A. The participants are being evaluated at more than 33 locations nationwide in a double-blind, placebo-controlled efficacy trial. Patients are randomly assigned to three groups, allowing comparison of Huperzine A 200µg bid, Huperzine A 400µg bid and a placebo.

The targeted increase in enrollment builds on the momentum currently enjoyed by Neuro-Hitech, which just merged with Q-RNA, Inc., a New York-based biotechnology company focused on diseases such as Alzheimer's, epilepsy and Parkinson's. The merger enables the company to benefit from a unique mix of expertise and experience that complements its existing strengths and resources.

"By expanding the trial, which has a projected completion date of late 2007, we believe the increased enrollment will enable us to enhance the power of this study, allow for an in-depth analysis of secondary measures, and position us to move forward with clinical development," said Reuben Seltzer, Neuro-Hitech's President and CEO. "We are very confident in the potential of this clinical trial and we look forward to the results, as well as the impact that a markedly improved drug in this class could have on the treatment of patients with Alzheimer's."

About Neuro-Hitech, Inc.

Neuro-Hitech, Inc. is a New York-based biopharmaceutical company that is focused specifically on developing next-generation therapies against proven targets for neurodegenerative diseases. Our lead product candidate, Huperzine A, is being clinically tested for efficacy in the treatment of Alzheimer's disease and has shown to protect nerve cell death and have longer duration of AChE inhibitory action. In addition to huperzine, Neuro-Hitech has two major preclinical development programs. The first program is developing second generation anti-amyloid compounds which target A-beta and Tau proteins. Neuro-Hitech's second major preclinical program is targeted to the development of a novel series of compounds designed to treat (anti-ictogenic) and prevent (anti-epileptogenic) epilepsy.

More information about Neuro-Hitech can be found 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 limitation, Neuro-Hitech's limited cash and ability to raise capital to finance the growth of Neuro-Hitech's operations, the ability of Neuro-Hitech to develop its products and obtain necessary governmental approvals, Neuro-Hitech's ability to protect its proprietary information, Neuro-Hitech's ability to attract or retain qualified personnel, including scientific and technical personnel and other risks detailed from time to time in Neuro-Hitech's filings with the SEC, or otherwise.

Contact Information

  • Company Contact:
    David Barrett
    CFO
    Neuro-Hitech, Inc.
    212-594-1215

    Investor Relations Contact:
    Thomas P. Walsh
    Alliance Advisors, LLC
    212-308-3486

    Media Contact:
    Ron Tomczyk
    GlobalFluency
    212-213-5400 x205