Newsroom 2006
Attention Business/Financial Editors:
Tramiprosate (ALZHEMED(TM)) Phase II Clinical Results Published in Neurology
Tramiprosate (ALZHEMED(TM)) Currently in Large Phase III Clinical Trials
in North America and Europe
LAVAL, QC, Nov. 2 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
is pleased to announce that Neurology, a worldwide, leading, peer-reviewed,
medical journal in the field of neurology, has published today an online
version of a publication on the Phase II clinical trial of tramiprosate
(3-amino-1-propanesulfonic acid (3APS); ALZHEMED(TM)) conducted in
mild-to-moderate Alzheimer's disease (AD) patients. Tramiprosate
(ALZHEMED(TM)) represents a potential new class of disease-modifying agents
and is Neurochem's investigational product candidate for the treatment of
Alzheimer's disease. The results reported in the paper demonstrate that
long-term administration of tramiprosate (ALZHEMED(TM)) is safe, tolerated and
reduces the level of amyloid (beta)42 (A(beta)42) in the cerebrospinal fluid
(CSF) of AD patients. In addition, mean ADAS-cog(1) and MMSE(2) scores
remained near baseline levels in the mild AD group over the 20 months of
follow-up.
The print issue of the publication will be available in the November 28,
2006 issue of Neurology. The article entitled "A phase II study targeting
amyloid (beta) with 3APS in mild-to-moderate Alzheimer disease" will be
highlighted in the "In This Issue" section of the journal. An electronic
version of the article is already accessible online, and can be found at
http://www.neurology.org under the "Expedited E-pub" section.
"This paper demonstrates the potential benefits of ALZHEMED(TM)," said
Dr. 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)). "The
ALZHEMED(TM) program is at the forefront of therapeutic research in AD. The
Phase II results show that ALZHEMED(TM) enters the central nervous system,
where it reduces levels of A(beta). We look forward to concluding the ongoing
North American Phase III clinical trial in January 2007, with the hope of
introducing a new therapeutic avenue for patients, and slowing the progression
of the disease," he concluded.
This Phase II clinical trial sought to assess the safety, tolerability,
pharmacokinetic, and pharmacodynamic activity of tramiprosate (ALZHEMED(TM))
in patients with mild-to-moderate AD using a three-month, double-blind,
randomized, and parallel group trial design. Patients who completed the Phase
II trial were then eligible to receive tramiprosate (ALZHEMED(TM)) in a
follow-on open-label study.
Findings about tramiprosate (ALZHEMED(TM)) reported in the article
include:
- Tramiprosate (ALZHEMED(TM)) had no significant impact on vital signs
and laboratory test values. The most frequent side effects were nausea,
vomiting and diarrhea, which were intermittent and mild-to-moderate in
severity.
- Tramiprosate (ALZHEMED(TM)) crossed the blood-brain-barrier, and dose-
dependently reduced CSF A(beta)42 levels after three months of
treatment. Results on psychometric measures showed no differences
between groups over the three-month double-blind period, consistent
with the proposed mechanism of action of tramiprosate (ALZHEMED(TM))
which is not expected to confer short-term symptomatic benefits.
- There was a gradual decline in the psychometric scores for subjects
remaining in the study over the course of the cumulative 20-month
follow-up period. By 20 months, the mean (SEM(3)) change from baseline
in psychometric scores for the mild and moderate groups were the
following: ADAS-cog: mild, 3.1 (2.3), moderate, 12.7 (2.6); CDR-SB(4),
mild 2.3 (0.9), moderate 2.8 (0.8).
About Tramiprosate (ALZHEMED(TM))
Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule known
as an amyloid (beta) antagonist, which crosses the blood-brain-barrier, binds
to soluble A(beta) peptide and interferes with the amyloid cascade that is
associated with amyloid deposition and the toxic effects of A(beta) 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(beta) peptide are toxic and causally related
to the severity of AD. The A(beta) peptide is one of the most promising
targets for the development of AD therapies.
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. 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) is a progressive form of dementia associated with
specific brain pathologies. It impairs a person's cognitive and motor
functions, their activities of daily living, alters their behavior and
gradually destroys the brain.
AD is the most common cause of dementia in our aging population. 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.
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 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 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.
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. The ADAS-cog scale quantifies the number of wrong answers.
Consequently, a high score on the scale indicates a more severe case of
cognitive decline. When analyzing results, a negative score indicates the
improvement of cognitive function and a positive score the deterioration
of such function. The ADAS-cog has been validated by the regulatory
authorities as the gold standard scale for the monitoring of cognitive
function in AD patients. This scale is a compulsory parameter of efficacy
when submitting an AD drug for market approval to the authorities such as
the U.S. Food and Drug Administration.
2- Mini-Mental State Examination (MMSE) is a standard mental status exam
routinely used to measure a person's basic cognitive skills, such as
short-term memory, long-term memory, orientation, writing and language.
If every answer is correct, a maximum score of 30 points is possible.
3- Standard Error of Mean (SEM).
4- 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, Ph.D., Vice President, Corporate
Communications, (450) 680-4570, lhebert@neurochem.com
