North American Phase III Clinical Trial on Alzhemed(TM) Fully Enrolled
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LAVAL, Sept. 13 /PRNewswire-FirstCall/ - Neurochem Inc. (NASDAQ: NRMX;
TSX: NRM) announced today that it has launched its European Phase III clinical
trial on Alzhemed(TM), following an investigators' meeting attended by more
than 250 clinicians and health professionals in Vienna, Austria, from
September 9 to September 11, 2005. Alzhemed(TM) is the Company's
investigational product candidate for the treatment of Alzheimer's disease
(AD). There are 73 centers in ten countries which have been selected by
Neurochem to conduct the trial, of which many are centres of excellence of the
European Alzheimer's Disease Consortium (EADC).
The multi-centre, randomized, double-blind, placebo-controlled and
parallel designed European Phase III clinical trial will investigate the
safety and efficacy of Alzhemed(TM) in treating AD, with some 930 mild-to-
moderate AD patients taking part in the trial. They will be randomized to
receive either placebo or one of two different dose levels of Alzhemed(TM) for
a period of 18 months, in addition to their regular treatment with one of a
number of acetylcholinesterase inhibitors.
In July, Neurochem completed the enrolment of 1052 mild-to-moderate AD
patients for its North American Phase III clinical trial on Alzhemed(TM). To
date, approximately 470 and 210 patients have completed six and nine months of
the North American trial, respectively. Both the European and North American
trials are designed to demonstrate the disease-modifying potential of
Alzhemed(TM).
"This Phase III clinical trial for Alzhemed(TM) is, in my view, the one
raising the most hope in Europe for the treatment of Alzheimer's disease,"
said Bruno Vellas, MD, Ph.D., Professor of Medicine and Chairman of the
Department of Internal Medicine and Geriatric Medicine, and Chief of the
Alzheimer's Disease Clinical and Research Center at the University Hospital
Center in Toulouse, France, and one of the Principal Investigators of
Alzhemed(TM)'s Phase III clinical trial in Europe for the EADC.
"Alzhemed(TM)'s good tolerability profile and unique mechanism of action
aimed at stopping the progression of the disease rather than targeting the
symptoms are particularly interesting. The enthusiasm evidenced by the large
attendance at our recent investigator meeting in Vienna for this Phase III
illustrates the European medical community's interest in and the excitement
about participating in this trial," he added.
"We are excited that Alzhemed(TM) is potentially first in a new class of
orally-available therapeutics developed to stop the progression of the
disease," said Denis Garceau, Ph.D., Senior Vice President, Drug Development
at Neurochem. He added that, "We are proud to collaborate during this Phase
III clinical trial with eminent European leaders in the AD field - medical
experts such as Professor Vellas - who are eager to find a treatment for this
debilitating disease."
About Alzhemed(TM)
Azhemed(TM) is an orally administered, small organic molecule
specifically designed to modify the course of AD by binding to soluble amyloid
(B) (A(B)) protein and keeping it in a non-fibrillar form. As reported
previously, results of the Phase II trial demonstrated that there were no
apparent safety findings of concern in patients treated with Alzhemed(TM) and
that the investigational product candidate was well tolerated in individuals
with mild-to-moderate AD.
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
includesUS$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 for neurological disorders. The Company's pipeline of
proprietary, disease-modifying oral products addresses critical unmet medical
needs. 1,3-propanedisulfonate (1,3PDS; Fibrillex(TM)) is designated as an
orphan drug and a Fast Track Product candidate and is also part of an FDA
Continuous Marketing Applications Pilot 2 program. The Phase II/III clinical
trial of Fibrillex(TM) for the treatment of AA Amyloidosis was recently
concluded. The Company is in the process of submitting a New Drug Application
(NDA) for Fibrillex(TM) that the FDA has agreed to file and review. 3-amino-1-
propanesulfonic acid (3APS; Alzhemed(TM)), for the treatment of Alzheimer's
disease, is in a Phase III clinical trial and 3APS (CerebrilTM), 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: http://www.neurochem.com .
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 Inc.'s
control. The 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
Inc. does business, stock market volatility, fluctuations in costs, and
changes to the competitive environment due to consolidation, as well as other
risks disclosed in public filings of Neurochem Inc. 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,
if any, the forward-looking statements included in this news release. These
statements speak only as of the date made and Neurochem Inc. is under no
obligation and disavows any intention to update or revise such statements as a
result of any event, circumstances or otherwise. Please see the Annual
Information Form for further risk factors that might affect the Company and
its business.
For further information, please contact:
Lise Hebert, PhD Tel: (450) 680-4571
Vice President, Corporate Communications Fax: (450) 680-4501
lhebert@neurochem.com
SOURCE NEUROCHEM INC.
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CONTACT: please contact: Lise Hebert, PhD, Vice President, Corporate Communications, lhebert@neurochem.com, (450) 680-4571, Fax: (450) 680-4501
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