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April 14, 2004
Neurochem announces additional positive results in on-going Phase II extension study for Alzhemed™.
Neurochem reports interim positive results in Alzheimer's patients after 16 months of treatment with
Alzhemed™ at 8th International Montreal/Springfield Symposium on Advances in Alzheimer Therapy.
- Neurochem, Inc. (NASDAQ: NRMX, TSX: NRM) - reported today additional positive interim data on
cognitive function in 18 patients with mild1-to-moderate2 Alzheimer's Disease (AD).
The results relate to patients who have completed both the three-month randomized Phase II clinical
trial and an additional 13 months of treatment in the open-label Phase II extension study (OLPES) with
the investigational product candidate, Alzhemed™. The data is based on cognitive function as
measured by the ADAS-cog3 test.
Out of the 30 AD patients who had previously completed 12 months of treatment on Alzhemed™,
Neurochem is reporting on the 23 mild-to-moderate AD patients who have received the product candidate
for 16 months. The mild-to-moderate AD patients (n=18)4 showed an average ADAS-cog score of
+2.33 points, as opposed to +9.65 points on average in comparable historical controls5 with
AD patients. The mild AD patients (n= 11) responded the best and showed a change from baseline in
their average ADAS-cog score of -0.09 points. This result compares favorably with a score of +7.62
points on average in comparable historical controls. Five patients discontinued the treatment but not
for reasons of drug related adverse events. The Company will report on the seven other patients
later once they complete 16-months of treatment with Alzhemed™.
Overall 82% of the mild AD patients had stabilized or improved cognitive function tests even after
16 months of treatment with Alzhemed™.
"Neurochem's product candidate, Alzhemed™ has the potential to modify the progression of AD by
acting directly on its core pathology, something which is of critical importance in the treatment of
this disease, and something we have not seen before," said Dr. Serge Gauthier, Professor of
Neurology and Neurosurgery, Psychiatry, Medicine and Associate Member of Pharmacology and Therapeutics
at McGill University, former President of the Consortium of Canadian Centres for Clinical Cognitive
Research (C5R) and co-President of the Symposium with Drs Ezio Giacobini and Jean-Pierre Michel from
Geneva. "Alzhemed™ represents what we believe will become the new paradigm for AD
treatment. Unlike current therapies, which treat just the symptoms of the disease, Alzhemed™ seems
to address the underlying cause. If cleared by regulatory agencies, Alzhemed™ could provide an
important treatment to benefit millions of Alzheimer patients," Dr. Gauthier concluded.
The complete data on all the patients who participated in the Phase II clinical trial and the OLPES
for a period of up to 20 months will be presented by Dr. Paul S. Aisen at the 9th International
Conference on Alzheimer's Disease and Related Disorders to be held in Philadelphia, Pennsylvania, USA,
from July 17 to July 22, 2004. Dr. Aisen is the principal investigator of the Phase III clinical trial
for Alzhemed™ in the United States, and is Professor of Neurology and Medicine at Georgetown
University Medical Center.
About Alzhemed™
Alzhemed™ is an orally administered, small organic molecule that has been specifically designed
to modify the course of AD through its anti-amyloid activity. As part of a "disease modifying"
novel class of product candidates, Alzhemed™ is expected to act at two levels: in preventing and
stopping the formation and the deposition of amyloid fibrils in the brain and in binding to soluble
Aß protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells
associated with amyloid build-up in AD.
About the Phase III Clinical Trials for Alzhemed™
Phase III clinical trials to evaluate the safety and efficacy of Alzhemed™ in AD are expected to
begin in the first half of 2004. In preparation for the initiation of the trials, the manufacturing of
the product candidate has been successfully completed and the selection of the clinical research
organization has been finalized.
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, which makes it hard for the person to participate in the day-to-day life.
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. It presents a major health
problem for the United States because of its enormous impact on individuals, families, the health
care system, and society as a whole. 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 also 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 AD is becoming the most
widespread and costly age-related disorder in the United States; the total cost of the disease has
been estimated at $100 billion per year.
About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's pipeline of proprietary, disease-modifying, oral products
addresses critical unmet medical needs. Fibrillex™, designated as an orphan drug and as Fast
Track Product candidate, is in a Phase II/III clinical trial for the treatment of Amyloid A
Amyloidosis. Alzhemed™ and Cerebril™ have completed a Phase II clinical trial for the
treatment of Alzheimer's Disease and for the prevention of Hemorrhagic Stroke caused by Cerebral
Amyloid Angiopathy respectively.
For additional information on Neurochem, please visit our website at: (www.neurochem.com).
1 - Mini Mental State Exam (MMSE): 19-25
2 - Mini Mental State Exam (MMSE): 13-18
3 - 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 analysing 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 for market approval of an AD drug to the authorities such as the Food and Drug Administration.
4 - n: number of patients per group.
5 - Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.
Certain statements contained in this news release, other than statements of fact that are independently
verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as
they are on the current expectations of management, inherently involve numerous risks and
uncertainties, known and unknown, many of which are beyond Neurochem's control. Such risks include
but are not limited to: the impact of general economic conditions, general conditions in the
pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which
Neurochem does business, stock market volatility, fluctuations in costs, and changes to the
competitive environment due to consolidation as well as other risks included in public filings of
Neurochem. Consequently, actual future results may differ materially from the anticipated results
expressed in the forward-looking statements. The reader should not place undue reliance on the
forward-looking statements included in this news release. These statements speak only as of the
date made and Neurochem is under no obligation and disavows any intention to update or revise such
statements as a result of any event, circumstances or otherwise.
For further Information, please contact:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
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