Newsroom 2006
Attention Business/Financial/Health Editors:
Neurochem receives recommendations from data safety monitoring boards to continue phase III clinical trials for tramiprosate (ALZHEMED(TM))
LAVAL, Nov. 6 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM),
announces that it has received recommendations from both the North American
and European Data Safety Monitoring Boards (DSMB) to continue its two Phase
III clinical trials currently ongoing for tramiprosate (ALZHEMED(TM)),
Neurochem's investigational product candidate for the treatment of Alzheimer's
disease (AD).
The two DSMBs are made up of independent clinical experts who monitor and
evaluate the safety of patients taking part in the tramiprosate (ALZHEMED(TM))
Phase III clinical trials. In North America, this fifth recommendation by the
DSMB was based on the recent review of the available safety data from 1,052
patients who have been on study medication for an average of 12.9 months. The
Company announced previous recommendations by the North American DSMB in
February 2006, and April, June and October 2005.
In Europe, this first recommendation by the DSMB members was based on
their recent review of the available safety data from 333 patients who have
been on study medication for an average of 1.8 months.
Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule
known as an amyloid (B) antagonist, which crosses the blood-brain-barrier,
binds to soluble A(B) peptide and interferes with the amyloid cascade that is
associated with amyloid deposition and the toxic effects of A(B) peptide in
the brain.
About the Phase III Clinical Trials for tramiprosate (ALZHEMED(TM))
Neurochem is currently conducting a multi-center, 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. The
trial is scheduled to be completed in January 2007. To date, 542 patients have
completed 18 months on study medication. All patients who complete the North
American Phase III clinical trial are eligible to receive tramiprosate
(ALZHEMED(TM)) in an open-label extension study.
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, an international,
multi-center, randomized, double-blind, placebo-controlled and
parallel-designed study, is progressing on schedule and is designed to
investigate the safety, efficacy and disease-modifying potential of
tramiprosate (ALZHEMED(TM)). Some 930 mild-to-moderate AD patients are
expected to take part and enrollment is expected to be completed in fall 2006.
About Alzheimer's Disease
Alzheimer's disease (AD), associated with specific brain pathologies, is
a progressive form, and the most common cause, of dementia. It impairs a
person's cognitive and motor functions, affects their ability to undertake
basic daily activities, alters their behavior and gradually destroys their
brain.
Current treatments for AD provide benefit to patients through the
alleviation of symptoms; however, the underlying disease is not directly
affected. Research is now capitalizing on advanced knowledge about the
biochemistry of A(B) and the pathway by which it is produced. The goal is the
development of disease-modifying therapies with the capacity to slow or arrest
the progression of AD.
Almost five million individuals in the United States alone currently
suffer from the condition. The U.S. Alzheimer's Association estimates that by
the year 2025, over 22 million people worldwide will be afflicted.
About Neurochem Inc.
Neurochem Inc. is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(KIACTA(TM)) is currently being developed for the treatment of AA amyloidosis,
and is under regulatory review for marketing approval by the U.S. Food and
Drug Administration and European Medicines Agency. 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 tramiprosate (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, Ph.D., Vice President, Corporate
Communications, (450) 680-4572, lhebert@neurochem.com
