The effect of Huperzine A on cognitive performance.
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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 200ug bid, Huperzine A 400ug 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."
Alzheimer's Donation
Donate Online Now
.
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 200ug bid, Huperzine A 400ug 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."
posted by Valery Yermalitsky at
7:49 AM
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