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Alzhemed Resumes Race for Alzheimer’s Cure with
Phase III Trial
July 5, 2005 – The Phase III clinical trial for
Alzhemed, a drug battling Flurizan for the top spot in Alzheimer’s
treatment research, is ready to begin in North America. Neurochem, Inc.,
the manufacturer, announced today the recruitment of 950 patients with
mild-to-moderate Alzheimer’s Disease for the trial to be conducted in 51
U.S. and 17 Canadian clinical centers.
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Ispronicline Joins Effort to Find Alzheimer’s Cure
July 6, 2005 – There is a new kid on the block in
the mad race to find a cure for Alzheimer’s disease and dementia.
Ispronicline is now enrolling participants for a Phase II study after
clinical studies in which elderly people taking Ispronicline performed
better on memory and attention measures than those taking a placebo.
Read more...
Is Flurizan the Alzheimer’s Treatment the World
Awaits?
Studies so far have shown modest results, new study
underway
June 21, 2005 – The media jumped all over the news
from the Dementia Prevention Conference about a possible treatment for
Alzheimer’s disease with the drug R-flurbiprofen (Flurizan) which is
entering a Phase III clinical trial. The results so far, however, have
been only mildly successful with the headlines on the Phase II study
being “Flurizan Phase II Trial Shows No Overall Benefit.” Still, there
is hope for this beta-amyloid altering drug being developed by Myriad
Pharmaceuticals. Read
more...
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The Company has completed the selection of sites
for a similarly sized Phase III clinical trial in Europe and expects to
begin patient recruitment in the fall of 2005.
In March, Decision Resources, Inc., one of the
world's leading research and advisory firms focusing on pharmaceutical
and health care issues, forecasts that the launches of Neurochem's
Alzhemed and Myriad Genetics' Flurizan will be major factors in driving
the market for the treatment of Alzheimer's disease to more than double
to $4 billion by 2013.
According to the new Pharmacor study entitled
Alzheimer's Disease, a dramatic change in market dynamics will begin
half way through the study's 2003 to 2013 forecast period, as the first
disease-modifying therapies—including Alzhemed (NC-531) and Flurizan (R-flurbiprofen)—enter
the market. These two therapies will account for more than 56% of
Alzheimer's disease treatment sales in the United States, Western Europe
and Japan, they predict.
“We believe Alzhemed may be able to provide
patients with real hope,” said Neurochem Chairman and President
Francesco Bellini.
"Completion of patient recruitment for the Phase
III Alzhemed clinical trial in North America is a major milestone for
the Company," Bellini said.
"To have recruited this large number of patients in
less than one year is an indication of the priority we have placed upon
developing this product candidate as well as the interest that Alzhemed
has raised to-date among researchers and physicians, he added.
The multi-center, randomized, double-blind,
placebo-controlled and parallel designed North American Phase III
clinical trial is investigating the safety and efficacy of Alzhemed for
the treatment of AD in mild-to-moderate patients.
The patients have been randomized to receive either
placebo or one of two different dose levels of Alzhemed (100mg or 150mg
twice daily) for a period of 18 months. All participants must be treated
with conventional AD therapies and must be on stable dose for at least
four months prior to the screening visit.
The two primary efficacy parameters are the change
from baseline to month 18 in the ADAS-cog and CDR-SB scores (Alzheimer's
Disease Assessment Scale, cognitive subpart (ADAS-cog); Clinical
Deterioration Scale Sum of Boxes).
The potential disease modification effect of
Alzhemed is also assessed by brain volume change from baseline as
measured by Magnetic Resonance Imaging.
The Phase II Trial
In 2003 Neurochem successfully completed the
randomized Phase II clinical trial for Alzhemed. This Phase II clinical
trial was a multi-centre, double-blind, placebo-controlled and
parallel-designed study. A total of 58 patients with mild-to-moderate AD
were randomized to receive either placebo or Alzhemed at daily doses of
100 mg, 200 mg or 300 mg for 12 weeks.
There were no safety findings of concern at the three doses tested. The
most frequent adverse events reported on Alzhemed were nausea and
vomiting, and their occurrence was dose-dependent. These adverse events
were transient and mild-to-moderate in severity.
The pharmacokinetic profile of Alzhemed was well characterized in this
AD patient population. The extent of systemic exposure was approximately
proportional to the administered dose. The bioanalysis revealed the
presence of Alzhemed in the CSF of AD patients and the levels appeared
to be dose-related. This important finding suggests that Alzhemed
crosses the blood brain barrier.
Patients who completed the three-month study were invited to participate
in an open-label extension study for an additional nine months. In this
on-going open-label study, all patients receive 300 mg of Alzhemed
daily.
Neurochem previously investigated the safety, tolerability and
pharmacokinetic profiles of Alzhemed in healthy volunteers in four Phase
I clinical trials. Its anti-amyloid effectiveness has also been
evaluated in a transgenic mouse model of brain, where tests demonstrated
that Neurochem's compound had a dose-dependent inhibitory effect on both
the deposition of cerebrovascular amyloid ß (Aß) and on Aß plasma
concentration.
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 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, all of which make it hard
for the person to participate in day-to-day activities.
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. 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 in the United States the total cost of AD is
approximately US$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. 1,3-propanedisulfonate (1,3PDS;
Fibrillex) 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 for the
treatment of AA Amyloidosis was recently concluded. The Company is in
the process of submitting a New Drug Application (NDA) for Fibrillex
that the FDA has agreed to file and review. 3-amino-1-propanesulfonic
acid (3APS; Alzhemed), for the treatment of Alzheimer's Disease, is in a
Phase III clinical trial and 3APS (Cerebril), for the prevention of
Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed
a Phase IIa clinical trial.
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