Newsroom 2007
Attention Business/Financial Editors:
Neurochem announcement regarding the completion of its North American phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease
LAVAL, QC, Feb. 1 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM)
announces the completion of its 18-month North American Phase III clinical
trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease
(AD). This study involved 1,052 patients, at 67 clinical sites across the
United States and Canada. The drop-out rate in the study was 24.8% and 791
patients were exposed to study medication for 18 months and completed their
last visit, as per protocol, except for two patients whose last study visits
are anticipated next week. Neurochem is on schedule to release the top-line
results of the clinical trial in the spring of this year, as previously
announced. Tramiprosate (ALZHEMED(TM)) is the Company's innovative
investigational product candidate aimed at arresting or stopping the
progression of AD.
Neurochem's North American Phase III clinical trial is a multi-center,
randomized, double-blind, placebo-controlled, three-armed and parallel
designed study. The primary objective of the clinical trial is to investigate
the safety, efficacy and disease-modifying potential of tramiprosate
(ALZHEMED(TM)) for the treatment of mild-to-moderate AD patients. The patients
were randomized to receive either placebo or one of two different dose levels
(100 mg or 150 mg twice daily) of tramiprosate (ALZHEMED(TM)) for a
period of 18 months. All participants were treated with conventional AD
therapies during the clinical trial and were required to be on a stable dose
of conventional therapies for at least four months prior to the initial
screening visit. At study entry, patients in this trial were on therapies for
an average of approximately 20 months.
The primary efficacy endpoints of this study include the evaluation of
cognitive abilities and a global measure of performance utilizing ADAS-cog(1)
and CDR-SB scores(2), respectively. If treatment efficacy is established, the
disease modification effect of tramiprosate (ALZHEMED(TM)) will then be
assessed by brain volume change from baseline as measured by magnetic
resonance imaging.
An open-label Phase III extension study was initiated in May of 2006.
Approximately 90% of the patients who completed the North American Phase III
clinical trial have continued into the ongoing extension study and receive
tramiprosate (ALZHEMED(TM)).
Over the course of the Phase III study, the Data Safety Monitoring Board
(DSMB) met five times and recommended in each instance that Neurochem continue
the clinical trial.
"The completion of our North American Phase III study is a major
milestone in Neurochem's efforts to potentially offer an innovative treatment
for Alzheimer's disease patients and marks a very important achievement for
our company," said Dr. Francesco Bellini, Chairman, President and CEO of
Neurochem. "Our goal is to release the results of this trial in the spring of
2007. We sincerely thank everyone who contributed to this state-of-the art
trial, with a special thanks to the patients, their families and their
caregivers who agreed to participate and helped us advance a program which
could lead to a potential breakthrough treatment for AD," he concluded.
Ongoing Phase III Clinical Trial in Europe Progressing Well
Neurochem is also currently advancing a European Phase III clinical trial
for tramiprosate (ALZHEMED(TM)) for the treatment of AD. The study in Europe
is of a similar design to the North American trial and is expected to recruit
approximately 930 mild-to-moderate AD patients at more than 70 clinical
centers in 10 European countries. The enrolment is scheduled to be completed
in early 2007. To date, the DSMB has met once and has recommended the
continuation of this trial.
About Tramiprosate (ALZHEMED(TM))
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. The presence of amyloid in the brain is one of the major
histopathological characteristics of AD. The amyloid cascade hypothesis
proposes that certain forms of A(B) peptide are toxic and causally related to
the severity of AD. The A(B) peptide is one of the most promising targets for
the development of AD therapies.
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 with 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 (incidence) 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.
(1) Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog).
The ADAS-cog is a 70-point scale designed to measure, with the use of
questionnaires, the progression and the severity of cognitive decline
as seen in AD.
(2) Clinical Dementia Rating - Sum of Boxes rating scale (CDR-SB), a
measure of global performance.
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, PhD, Vice President, Corporate
Communications, (450) 680-4572, Fax: (450) 680-4501, lhebert@neurochem.com
