Neuro-Hitech Reports Cognitive Improvement From Phase Two Clinical Trial of Huperzine A In Alzheimer's Disease Patients
NEW YORK--(Business Wire)--
Neuro-Hitech, Inc. (NASDAQ: NHPI), a New York-based
biopharmaceutical company focused on developing innovative drugs for
the treatment of neurodegenerative diseases, today announced top-line
results from the double-blind part of a phase 2 clinical trial of
Huperzine A in mild to moderate Alzheimer's disease (AD) patients.
The phase 2 clinical trial was conducted in the United States in
collaboration with the National Institute on Aging and the Alzheimer's
Disease Cooperative Study Group (ADCS). The study is a multi-center,
randomized, double-blind, placebo-controlled trial in 210 patients
with mild to moderate Alzheimer's disease. The trial compared the
safety, tolerability and efficacy of either 200 or 400 micrograms of
Huperzine A administered orally twice a day for 16 weeks versus
placebo. The study measured the efficacy of Huperzine A on cognitive
function, activities of daily living and behavior. Of the 210 patients
enrolled in this study approximately half received concomitant
treatment with Namenda(R) an FDA approved drug for Alzheimer's
disease.
Results showed that there was no statistical difference in the
mean change on AD Assessment Scale- Cognitive (ADAS-Cog) scores, the
primary endpoint, after 16 weeks treatment with Huperzine A 200
micrograms bid compared to placebo (p=0.81). However, data
demonstrated that the higher dose tested, 400 micrograms bid, showed
cognitive enhancement on the ADAS-Cog versus placebo. The maximum
cognitive improvement was observed at week 11 of treatment (p=0.001).
Over 16 weeks Huperzine A (400 micrograms bid) improved cognition
compared to placebo (p=0.03) and there was a trend to cognitive
improvement over placebo at week 16 (p=0.069). In this clinical trial,
there was an unexpected improvement in cognition in the placebo group
at week 16 versus baseline.
On other secondary endpoints, including clinical global impression
of change (ADCS-CGIC) and the Neuropsychiatric Inventory (NPI) there
was no statistical difference between placebo and either 200 or 400
micrograms bid after 4 months treatment. However, there was a trend to
improvement on activities of daily living (ADCS-ADL) with 400
micrograms bid (p=0.077).
Huperzine A was safe and well tolerated. Overall the incidence of
adverse events during the study was similar between both doses of
Huperzine A and placebo.
Gary T. Shearman, Ph. D. President and Chief Executive Officer of
Neuro-Hitech stated, "Although this clinical trial did not meet the
primary endpoint, we are encouraged that the higher dose of Huperzine
A studied improved cognitive performance compared to placebo and that
the drug was safe and well tolerated in mild to moderate Alzheimer's
patients. The main purpose of this Phase 2 clinical trial was to
gather data to inform us on the appropriate design of the pivotal
Phase 3 registration studies required for marketing approval of
Huperzine A."
Paul Aisen, MD, Director of the ADCS, Professor of Neurosciences
at the University of California, San Diego and Principal Investigator
for this clinical study stated, "This US Phase II trial has clearly
demonstrated efficacy of Huperzine A in the treatment of AD.
Completion of the planned analyses, including examination of drug
levels and cholinesterase inhibition, will be valuable in the design
of further studies. I look forward to continued development of the
compound with exploration of possible disease-modifying effects."
Following completion of the double-blind part of this clinical
trial, subjects were invited to receive Huperzine A treatment in an
open-label fashion for up to one year. Eight two percent of subjects
accepted this invitation
CONFERENCE CALL: Neuro-Hitech plans to sponsor a conference call
for investors to discuss these results on Monday, February 4, 2008, at
12:00 p.m. EST. Joining Neuro-Hitech will be Paul Aisen, MD, Principal
Investigator for this clinical study. Investors may listen to the call
by dialing 866-901-2585 or 404-835-7099, ten to fifteen minutes before
the start of the call. Interested parties who wish to listen to the
webcast should visit the Neuro-Hitech web-site at www.neurohitech.com.
The archive of the conference call will be available approximately two
days after the conference call and will be available for several days.
About Huperzine A
Huperzine A is a naturally occurring alkaloid compound derived
from the club moss Huperzia serrata. Huperzine A is a highly potent
and selective reversible inhibitor of acetylcholinesterase. In
addition, Huperzine A possesses neuroprotective properties against
glutamate induced neuronal toxicity at the NMDA receptor and has
antioxidative properties. Furthermore, Huperzine A reduces the
neurotoxic effects of B-amyloid and diminishes B-amyloid generation.
In addition to the oral formulation currently being clinically
studied, NHPI is also developing the drug in a transdermal patch.
About Neuro Hitech, Inc.
Neuro-Hitech, Inc. is a New York-based biopharmaceutical company
that is focused on developing innovative drugs for the treatment of
neurodegenerative diseases. Our lead product candidate, Huperzine A,
is being clinically tested for safety and efficacy in the treatment of
Alzheimer's disease. The company's other programs include innovative
compounds for epilepsy and disease-modifying compounds for Alzheimer's
disease that block aggregation of B-amyloid and tau-proteins.
More information about Neuro-Hitech can be found online at
www.neurohitech.com.
About Alzheimer's Disease(1)
Alzheimer's disease is a progressive neurodegenerative disorder
that attacks the brain's nerve cells or neurons, resulting in loss of
memory, thinking and language skills and behavioral changes.
Alzheimer's disease is the most common cause of dementia, or loss of
intellectual function among people aged 65 and older.
About the Alzheimer's Disease Cooperative Study
The Alzheimer's Disease Cooperative Study (ADCS) is a consortium
of approximately 35 academic medical centers funded by the National
Institute on Aging for the purpose of conducting clinical trials in
Alzheimer's disease.
More information about ADCS can be found online at
https://adcs.ucsd.edu/.
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.
(1) Alzheimer's Foundation of America website
Neuro-Hitech, Inc.
David Barrett, CFO
212-594-1215
or
The Trout Group LLC
Brandon D. Lewis
Managing Director
740 Broadway, 9th Floor
New York, NY 10003
Direct (646) 378-2915
Copyright Business Wire 2008
