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Alzheimer's & Dementia
Report on Alzhemed Clinical Trial Says Alzheimer's
Stabilized in 4 of 9
Tramiprostate product reduces amyloid accumulation - major culprit in AD
April 24, 2006 A presentation Saturday on the
potential use of tramiprostate (Alzhemed) in the treatment of
Alzheimer's disease said stabilization of the disease occurred in four
out of nine patients with a mild form of AD after three years of
treatment.
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Alzheimer's & Dementia |
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"Overall, the Alzhemed program is very exciting.
The fact that this product can reduce amyloid accumulation, a major
culprit in Alzheimer's disease, and provide a protective effect against
amyloid-induced toxicity to brain cells is encouraging," said 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).
"Developing a successful treatment to slow the
progression of this disease, which today remains an unmet medical need,
would be a major advance in the fields of neurology and age-related
illnesses," he concluded.
The presentation on Neurochem's investigational
product candidate for the treatment of AD by Dr. Aisen took place on
April 22, in Geneva, Switzerland, at the 9th International
Geneva/Springfield Symposium on Advances in Alzheimer Therapy.
The data from the open-label extension study of the
Phase II clinical trial for tramiprosate, involving mild-to-moderate AD
patients, continues to show clinically significant benefits on cognitive
and global performance measures, with stabilization of the disease in a
proportion of mild patients (four out of nine) after three years of
treatment.
Furthermore, Dr. Aisen presented for the first time
further results on the mechanism of action of tramiprosate (Alzhemed).
In addition to the capability of tramiprosate (Alzhemed) to bind to
soluble amyloid (B) (A(B)) peptide and interfere with the amyloid
cascade, data from in vitro studies have shown that tramiprosate
(Alzhemed) has a protective effect on neuronal cells against A(B)
peptide-induced toxicity and cell death. Tramiprosate (Alzhemed)
decreases A(B)42-induced cell death and DNA damage in neuronal cell
cultures by 38% (p-value less than 0.01).
About the Phase III Clinical Trials for Alzhemed
Neurochem is currently conducting a 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, more than 50 patients have completed the
trial and more than 500 patients have completed 12 months on study
medication. The trial is now 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) in an open-label extension study. As announced
previously, this open-label extension study will be initiated in the
second quarter of 2006.
Neurochem is also actively advancing an 18-month
Phase III clinical trial for tramiprosate (Alzhemed) in Europe, which
was initiated in September 2005. The ongoing European Phase III clinical
trial, a multi-center, international, randomized, double-blind,
placebo-controlled and parallel designed study, to investigate the
safety and efficacy of tramiprosate (Alzhemed) in some 930
mild-to-moderate AD patients, is progressing on schedule.
Enrollment is brisk with more than 230 patients
enrolled in the clinical trial and enrollment expected to be completed
in the fall of 2006.
About tramiprosate (Alzhemed)
Tramiprosate (Alzhemed) is a small,
orally-administered molecule known as an amyloid (B) antagonist that
crosses the blood-brain-barrier, binds to soluble A(B) peptide and
interferes with the amyloid cascade, inhibits A(B) protein deposition in
the brain and provides protection against A(B)-induced neurotoxicity.
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 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 says it is focused on the development and
commercialization of innovative therapeutics to address critical unmet
medical needs. Eprodisate (Fibrillex) is designated as an orphan drug,
is a Fast Track product candidate and is also part of FDA Continuous
Marketing Application Pilot 1 and Pilot 2 programs. The FDA designated
the eprodisate (Fibrillex) new drug application for priority review.
Tramiprosate (Alzhemed), for the treatment of Alzheimer's disease, is
currently in Phase III clinical trials in both North America and Europe,
and tramiprosate (Cerebril), for the prevention of Hemorrhagic Stroke
caused by Cerebral Amyloid Angiopathy, has completed a Phase IIa
clinical trial. Neurochem, Inc. (NASDAQ:
NRMX) (NASDAQ:TSX:)
(NASDAQ:NRM)
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