Newsroom 2006
Attention Business/Financial Editors:
Neurochem presents an update on tramiprosate (Alzhemed(TM)) program for the treatment of Alzheimer's disease at 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy
LAVAL, QC, April 24 /CNW Telbec/ - Neurochem, Inc. (NASDAQ: NRMX, TSX:
NRM). - Paul S. Aisen, M.D., Professor of Neurology and Medicine at Georgetown
University Medical Center, and principal investigator in the United States of
the ongoing Phase III clinical trial for tramiprosate (Alzhemed(TM)) presented
an update on Neurochem's investigational product candidate for the treatment
of Alzheimer's disease (AD). The presentation by Dr. Aisen took place on April
22, in Geneva, Switzerland, at the 9th International Geneva/Springfield
Symposium on Advances in Alzheimer Therapy.
The data from the open-label extension study of the Phase II clinical
trial for tramiprosate (Alzhemed(TM)), involving mild-to-moderate AD patients,
continues to show clinically significant benefits on cognitive and global
performance measures, with stabilization of the disease in a proportion of
mild patients (four out of nine) after three years of treatment. Furthermore,
Dr. Aisen presented for the first time further results on the mechanism of
action of tramiprosate (Alzhemed(TM)). In addition to the capability of
tramiprosate (Alzhemed(TM)) to bind to soluble amyloid (B) (A(B)) peptide and
interfere with the amyloid cascade, data from in vitro studies have shown that
tramiprosate (Alzhemed(TM)) has a protective effect on neuronal cells against
A(B) peptide-induced toxicity and cell death. Tramiprosate (Alzhemed(TM))
decreases A(B)42-induced cell death and DNA damage in neuronal cell cultures
by 38% (p-value less than 0.01). A copy of the presentation is available upon
request.
"Overall, the Alzhemed(TM) program is very exciting. The fact that this
product can reduce amyloid accumulation, a major culprit in Alzheimer's
disease, and provide a protective effect against amyloid-induced toxicity to
brain cells is encouraging," said Dr. Aisen. "Developing a successful
treatment to slow the progression of this disease, which today remains an
unmet medical need, would be a major advance in the fields of neurology and
age-related illnesses," he concluded.
About the Phase III Clinical Trials for tramiprosate (Alzhemed(TM))
Neurochem is currently conducting a randomized, double-blind, placebo-
controlled and parallel designed 18-month Phase III clinical trial in 1,052
mild-to-moderate AD patients, which is being carried out at close to 70
clinical sites across the United States and Canada. To date, more than 50
patients have completed the trial and more than 500 patients have completed 12
months on study medication. The trial is now scheduled to be completed by
January 2007. All patients who complete the North American Phase III clinical
trial will be offered the opportunity to receive tramiprosate (Alzhemed(TM))
in an open-label extension study. As announced previously, this open-label
extension study will be initiated in the second quarter of 2006.
Neurochem is also actively advancing an 18-month Phase III clinical trial
for tramiprosate (Alzhemed(TM)) in Europe, which was initiated in September
2005. The ongoing European Phase III clinical trial, a multi-center,
international, randomized, double-blind, placebo-controlled and parallel
designed study, to investigate the safety and efficacy of tramiprosate
(Alzhemed(TM)) in some 930 mild-to-moderate AD patients, is progressing on
schedule. Enrollment is brisk with more than 230 patients enrolled in the
clinical trial and enrollment expected to be completed in the fall of 2006.
About tramiprosate (Alzhemed(TM))
Tramiprosate (Alzhemed(TM)) is a small, orally-administered molecule
known as an amyloid (B) antagonist that crosses the blood-brain-barrier, binds
to soluble A(B) peptide and interferes with the amyloid cascade, inhibits A(B)
protein deposition in the brain and provides protection against A(B)-induced
neurotoxicity.
About Alzheimer's disease
Alzheimer's disease (AD) is a progressive form of dementia associated
with specific brain pathologies. It impairs a person's cognitive and motor
functions and gradually destroys the brain.
AD is the most common cause of dementia in our aging population. Almost
5 million individuals in the United States alone currently suffer from the
condition. The U.S. Alzheimer's Association estimates that by 2025, over
22 million people worldwide will be afflicted.
According to a report commissioned by the U.S. Alzheimer's Association,
AD costs American businesses approximately US$61 billion a year. That price
tag includes US$24.6 billion for direct health care of Alzheimer's patients
and US$36.5 billion to cover costs related to caregivers of AD patients,
including lost productivity, absenteeism and worker replacement.
About Neurochem
Neurochem is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Fibrillex(TM)) is designated as an orphan drug, is a Fast Track product
candidate and is also part of FDA Continuous Marketing Application Pilot 1 and
Pilot 2 programs. The FDA designated the eprodisate (Fibrillex(TM)) new drug
application for priority review. Tramiprosate (Alzhemed(TM)), for the
treatment of Alzheimer's disease, is currently in Phase III clinical trials in
both North America and Europe, and tramiprosate (Cerebril(TM)), for the
prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has
completed a Phase IIa clinical trial.
To Contact Neurochem
For additional information on Neurochem and its drug development
programs, please call the North American toll-free number 1-877-680-4500 or
visit our Web Site at www.neurochem.com .
This news release contains forward-looking statements regarding
tramiprosate (Alzhemed(TM)), as well as regarding continuing and further
development efforts. These statements are based on the current analysis and
expectations of management. Drug development necessarily involves numerous
risks and uncertainties, which could cause actual results to differ materially
from this current analysis and these expectations. Analysis regarding the
results of clinical trials may not provide definitive results regarding
safety, tolerability or therapeutic benefits. Even if all the endpoints sought
in the clinical trials were met (which is not certain), there is no certainty
that regulators would ultimately approve Alzhemed(TM) for sale to the public.
Risks and uncertainties may include: failure to demonstrate the safety,
tolerability and efficacy of our product, the expense and uncertainty of
obtaining regulatory approval, including from the FDA, and the possibility of
having to conduct additional clinical trials. Further, even if regulatory
approval is obtained, therapeutic products are generally subject to: stringent
on-going governmental regulation, challenges in gaining market acceptance, and
competition. Neurochem does not undertake any obligation to publicly update
its forward-looking statements, whether as a result of new information, future
events, or otherwise. Please see the Annual Information Form for further risk
factors that might affect the Company and its business.
For further information: Lise Hébert, PhDVice President, Corporate
Communications, 1-450-680-4570, lhebert@neurochem.com
