Newsroom 2006
Attention Business/Financial Editors:
Tramiprosate (Alzhemed(TM)) preclinical results published in Neurobiology of Aging
Tramiprosate (Alzhemed(TM)) currently in large Phase III clinical trials
in North America and Europe
LAVAL, May 30 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) is
pleased to announce that Neurobiology of Aging, one of the world's leading
peer-reviewed medical journals in the fields of gerontology and neuroscience,
has published an online version of a publication on the preclinical
development of tramiprosate (3-amino-1-propanesulfonic acid; Alzhemed(TM)),
including efficacy results in a mouse model of brain amyloidosis. Tramiprosate
(Alzhemed(TM)) represents a potential new class of therapeutic agent and is
Neurochem's investigational product candidate for the treatment of Alzheimer's
disease (AD). The results presented in this paper include the amyloid binding
and neuroprotective characteristics of tramiprosate (Alzhemed(TM)) and provide
evidence for the potential disease-modifying effect of this product candidate
to slow or arrest the progression of AD.
While the paper issue of the publication will be available in a future
issue of Neurobiology of Aging, an electronic version of the article entitled
"Targeting soluble A(B) peptide with Tramiprosate for the treatment of brain
amyloidosis" is already accessible online, and can be found at
http://www.sciencedirect.com by searching for "tramiprosate".
Findings about tramiprosate (Alzhemed(TM)) include:
- Tramiprosate (Alzhemed(TM)) binds preferentially to soluble A(B)
peptide and maintains A(B) in a non-fibrillar form.
- Tramiprosate (Alzhemed(TM)) decreases by 38% (p-value less than 0.01)
A(B)42-induced cell death in primary rat neuronal cell cultures.
- Tramiprosate (Alzhemed(TM)) treatment in a transgenic mouse model of
brain amyloidosis resulted in a dose-dependent reduction of over 60% of
A(B) levels in plasma. There were significant decreases in brain levels
of both soluble A(B)40 (30%; p-value of 0.014) and insoluble A(B)40
(31%; p-value of 0.035). Corresponding decreases of 25% (p-value of
0.033) and 22% (p-value of 0.029) were observed for the soluble and
insoluble fractions of A(B)42 peptide, respectively.
- Tramiprosate (Alzhemed(TM)) crosses the blood-brain-barrier to exert
its activity with low toxicity in various animal species that were
tested.
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.
"This scientific paper highlights the potential benefits of
Alzhemed(TM)," said Dr. Andreas Orfanos, Neurochem's Executive Vice President,
Strategic Planning and Scientific Affairs. "These preclinical results indicate
that Alzhemed(TM) binds preferentially to soluble amyloid (B) peptide,
interferes with the amyloid cascade and reduces the associated toxicity.
Accordingly, this product candidate is shown to impede key detrimental events
normally associated with Alzheimer's disease and which are believed to lead to
severe consequences in the brain of the affected individuals."
About tramiprosate (Alzhemed(TM))
Tramiprosate (Alzhemed(TM)) is a small, orally-administered molecule
known as an amyloid (B) antagonist, designed to cross the blood-brain-barrier,
bind to soluble A(B) peptide and interfere with the amyloid cascade, thereby
leading to the prevention or inhibition of 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. To date, 600
patients have already completed 12 months on study medication and the trial is
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.
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 will 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 the fall of 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 the behaviour 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 the U.S. Food and Drug Administration (FDA)
Continuous Marketing Application Pilot 1 and Pilot 2 programs. In April 2006,
the FDA filed and granted 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 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, 1-450-680-4570, lhebert@neurochem.com