Neurochem will host a conference call tomorrow August 27, 2007, at 8:30 AM
LAVAL, QC, Aug. 26 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announces today top-line results from the North American Phase III clinical
trial designed to assess the safety, efficacy and disease modification effect
of tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD).
Following a recent meeting with the U.S. Food and Drug Administration (FDA)
and subsequent statistical analyses, the Company announces that the North
American Phase III clinical trial for tramiprosate (ALZHEMED(TM)), despite the
descriptive data showing numerical differences, did not demonstrate a
statistically significant difference in favor of tramiprosate (ALZHEMED(TM))
with respect to the primary endpoints over 18 months of treatment. However, a
substantial difference observed in hippocampal volume did approach statistical
significance. Due to significant interference from high between-site
variations that complicated the statistical analyses beyond expectations, it
is not possible to draw definitive conclusions with respect to the treatment
effect of tramiprosate (ALZHEMED(TM)).
At the recent FDA meeting, Neurochem sought feedback on appropriate next
steps, especially with respect to the statistical models and the detailed
analysis of potential confounding factors. The agency recognized the difficult
issues surrounding a trial of this magnitude, with its significant site effect
and the large number of covariates identified during the modeling process, and
advised that neither the proposed adjusted models nor any further adjustments
could be used for this trial to provide results in support of a claim of
clinical efficacy. The agency recognized that it might be possible to utilize
the findings of the North American Phase III study to potentially revise the
statistical analysis plan and/or modify the study design of the ongoing
European Phase III clinical trial.
Neurochem will continue to evaluate the treatment effect of tramiprosate
(ALZHEMED(TM)) with post-hoc evaluations to facilitate its understanding of
the data and assess any treatment effect from the North American trial.
Neurochem has established a Special Advisory Board, chaired by Dr.
Rachelle S. Doody, M.D., Ph.D., the Effie Marie Cain Chair in Alzheimer's
Disease Research at the Alzheimer's Disease and Memory Disorders Center,
Baylor College of Medicine in Houston, Texas. The Advisory Board will comprise
regulatory, medical and statistical experts from the fields of AD,
therapeutics for the central nervous system, functional assessments, imaging,
biomarkers, and clinical trial design. The purpose of the Advisory Board will
be to assist Neurochem over the coming months in reviewing and analyzing the
data from the North American Phase III clinical trial. The Advisory Board's
mandate will also be to provide advice to Neurochem as it considers its
options for the future direction of the tramiprosate (ALZHEMED(TM)) program.
Tramiprosate (ALZHEMED(TM)) was generally safe and well tolerated. The
incidence of serious adverse events reported in patients treated with
tramiprosate (ALZHEMED(TM)) was comparable to the incidence for patients in
the placebo group. The most common adverse events ((greater than)10%) reported
more frequently for tramiprosate (ALZHEMED(TM)) than placebo were nausea,
falling, diarrhea, dizziness, body weight decrease and vomiting.
About the Phase III Clinical Trials in North America and Europe
The North American study was a multicenter, randomized, double-blind,
placebo-controlled, three-armed and parallel-designed, 18-month Phase III
clinical trial. The study included 1,052 patients with mild-to-moderate AD
recruited across 67 sites in Canada and the United States who were randomized
to receive either placebo or one of two doses (100mg or 150mg twice daily) of
tramiprosate (ALZHEMED(TM)). All patients were required to be treated with
conventional symptomatic AD therapies during the clinical trial and were
required to be on a stable dose of such therapies for at least four months
prior to the initial screening visit of the trial.
Neurochem is also currently conducting a European Phase III clinical
trial for tramiprosate (ALZHEMED(TM)) for the treatment of AD. To date, 966
mild-to-moderate AD patients are enrolled at 69 clinical centers in 10
European countries. The European Data Safety Monitoring Board has met three
times and recommended on each occasion that the study should continue. In
August 2007, Neurochem stopped patient screening activities as it had met its
recruitment target and it is presently considering potential modifications to
the European study to take best advantage of the experience gained from the
recently completed North American Phase III clinical trial.
About Tramiprosate (ALZHEMED(TM))
Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule
known as an amyloid B antagonist. Tramiprosate (ALZHEMED(TM)) crosses the
blood-brain-barrier, binds to soluble AB peptide and interferes with the
amyloid cascade that is associated with amyloid deposition and the toxic
effects of AB peptide in the brain. The presence of amyloid in the brain is
one of the major histopathological characteristics of AD.
Tramiprosate (ALZHEMED(TM)) received Fast Track designation from the FDA
for the treatment of mild-to-moderate Alzheimer's disease. Fast Track
designation facilitates development and may expedite regulatory review of
drugs that the FDA recognizes as potentially addressing an unmet medical need
for serious or life-threatening conditions.
About Alzheimer's Disease
AD is a leading cause of death in the elderly. 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, all of which make it difficult for the person to participate
in daily activities.
According to the U.S. Alzheimer Association (2007), there are now more
than five million people in the United States living with Alzheimer's disease.
This number includes 4.9 million people aged 65 and older. It also includes at
least 200,000 individuals younger than 65 with early-onset Alzheimer's
disease. It is estimated that there will be 454,000 new cases of AD a year by
2010, 615,000 new cases by 2030 and 959,000 new cases by 2050. In the United
States, the direct and indirect costs of AD and other dementias amount to more
than US$148 billion annually.
Neurochem will host a conference call on August 27, 2007, at 8:30 AM EDT.
The telephone numbers to access the conference call are 1-416-644-3423 or
1-800-814-4861. A replay of the call will be available until Monday, September
3, 2007. The telephone numbers to access the replay of the call are
1-416-640-1917 or 1-877-289-8525. The access code for the replay is 21245159#.
Neurochem Inc. is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(KIACTA(TM)) is currently being developed for the treatment of Amyloid A
amyloidosis, and is under regulatory review for marketing approval by the U.S.
Food and Drug Administration, the European Medicines Agency and Swissmedic.
Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer's disease, has
been the subject of a completed Phase III clinical trial in North America and
is currently being studied in a Phase III clinical trial in Europe, while
tramiprosate (CEREBRIL(TM)), for the prevention of hemorrhagic stroke caused
by cerebral amyloid angiopathy, has been studied in a completed Phase IIa
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 the 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, that actual results may vary
once the final and quality-controlled verification of data and analyses has
been completed, 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:
For further information: Dr. Lise Hébert, Vice President, Corporate
Communications, (450) 680-4572, email@example.com