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January 22, 2004
Additional Results In On-going Phase II Extension Study.
Neurochem reports interim positive results in Alzheimer's patients after 12 months
of treatment with Alzhemed™.
- Neurochem, Inc. (NASDAQ: NRMX, TSX: NRM) - reported today additional positive interim data on
cognitive function in the 30 patients with mild1-to-moderate2 Alzheimer's Disease
(AD). The results relate to patients who have completed both the three-month Phase II clinical trial
and an additional 9 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 and follows upon earlier interim results published on
patients who had completed either nine or 12 months of treatment.
"The data is very promising and unique," said Denis Garceau, Ph.D., Vice President, Drug
Development, at Neurochem. "The mild AD patients continue to do very well after 12 months of
treatment with Alzhemed™ and the medication is still very well tolerated. Even after one year of
treatment with Alzhemed, 72% of the mild AD patients were stabilized or improved on the cognitive
function test," he concluded.
The initial and successful three-month Phase II clinical trial, on which Neurochem previously reported
in June 2003, included 58 AD patients who were subdivided into four groups: placebo or treated with
either 100, 200, or 300 mg of Alzhemed daily. Once the three-month Phase II trial was completed, the
OLPES was initiated with 42 patients, of which 30 have now completed 9 months of additional treatment
with 300 mg daily of Alzhemed™. Twelve patients discontinued the treatment and only one due to
a drug-related adverse event (nausea and vomiting).
Neurochem is now reporting the interim data on all the mild-to-moderate AD patients (n= 30)4
who have completed 12 months of Alzhemed therapy since the initiation of the overall study. The mild AD
patients (n= 18) showed a change from baseline in ADAS-cog score of +1.4 points on average. This result
compares favorably with a score of +5.6 points in comparable historical controls5. Mild AD
patients who were on the 300 mg dose of Alzhemed™ for the entire 12-month period performed
best, with an ADAS-cog score of -0.6 points on average (n= 6) as opposed to +5.8 points on average
in comparable historical controls.
For the 30 mild-to-moderate patients, Neurochem is reporting an average ADAS-cog score of +4.4 points
after 12 months, as opposed to +7.2 points on average in comparable historical controls with AD
patients. Again, patients who have been receiving the highest dose of Alzhemed™ for the entire
12-month period performed best, with a score of +2.0 points on average (n= 9) as opposed to +7.1 points
on average in comparable historical controls.
"It is very encouraging to see, in patients with AD, stabilized and improved cognitive function
for as long as an entire year of treatment with Alzhemed™," added Dr. Garceau. "We
realize that the patient sample for this extended Phase II trial is small and we are designing our
Phase III studies to allow the statistical analysis of the results."
Neurochem recently held positive and productive discussions with officials from the U.S. Food and
Drug Administration (FDA) regarding the Company's Phase III clinical trials on Alzhemed™.
Preparations to initiate Phase III clinical trials on Alzhemed™ are underway, and are expected
to be initiated in the spring of this year as scheduled.
About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's staged pipeline of proprietary, disease-modifying, oral products
addresses critical unmet medical needs. Fibrillex™, designated an orphan drug, is in a Phase
II/III clinical trial for AA amyloidosis. Alzhemed™ has completed a Phase II clinical trial for
the treatment of Alzheimer's Disease. Cerebril™ is in a Phase II trial for the prevention of
hemorrhagic stroke caused by cerebral amyloid angiopathy. 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.
All of the statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, are forward-looking statements. Such statements, based
as they are on the current expectations of management, inherently involve numerous risks and
uncertainties, known and unknown. Some examples of known risks are: 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 or otherwise. Consequently,
actual future results may differ materially from the anticipated results expressed in the
forward-looking statements.
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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