Neurochem receives second recommendation from European Data Safety Monitoring Board to continue Phase III clinical trial for tramiprosate (ALZHEMED(TM))
LAVAL, QC, Feb. 13 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announces that it has received a second recommendation from the European Data
Safety Monitoring Board (DSMB) to continue its ongoing European Phase III
clinical trial for tramiprosate (ALZHEMED(TM)), Neurochem's investigational
product candidate for the treatment of Alzheimer's disease (AD). Neurochem
recently completed its North American Phase III clinical trial involving
1,052 patients at 67 sites. For the North American trial, Neurochem received
five consecutive recommendations from the North American DSMB to proceed.
Each DSMB is 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 Europe, this second recommendation by the DSMB
members was based on their recent review of the available safety data from
491 patients who have been on study medication for an average of 3.6 months.
The North American Phase III clinical trial was a multi-center,
randomized, double-blind, placebo-controlled, three-armed and parallel-
designed, 18-month Phase III clinical trial. All patients who completed the
North American Phase III clinical trial were eligible to receive tramiprosate
(ALZHEMED(TM)) in an open-label extension study.
Neurochem is progressing with its 18-month Phase III clinical trial for
tramiprosate (ALZHEMED(TM)) in Europe. This trial was initiated in September
2005 and is of a design similar to the North American trial. Some 930 mild-to-
moderate AD patients at close to 70 sites across ten countries are expected to
take part and enrollment is expected to be completed in early 2007.
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 Alzheimer's Disease
AD is a leading cause of death in older people. The disease is
characterized by the progressive death of nerve cells in the brain, making it
difficult for the brain's signals to be transmitted properly. A person with
AD experiences problems with memory, judgment, thinking, and eventually with
motor functions, all of which make it difficult for the person to participate
in daily activities.
According to the National Institute on Aging's "Progress Report on
Alzheimer's Disease, 2000," AD is the most common cause of dementia among
people aged 65 and older. Scientists estimate that up to four and a half
million people in the United States currently suffer from the disease and the
prevalence (the number of people with the disease at any one time) doubles
every five years beyond age 65. It is estimated that approximately 360,000 new
cases will occur each year and that this number will increase as the
population ages.
In a 2000 report, the Biotechnology Industry Organization estimated that
in the United States the total cost of AD is approximately US$100 billion per
year.
About Neurochem
Neurochem Inc. is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(KIACTA(TM) - formerly FIBRILLEX(TM)) is currently being developed for the
treatment of Amyloid A (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, has completed a Phase III clinical trial in North America
and is currently in a Phase III clinical trial in Europe, while 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: please contact: Lise Hébert, Ph.D., Vice
President, Corporate Communications, (450) 680-4572, lhebert@neurochem.com