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April 4, 2002
Neurochem presents Phase I Clinical Trial results and proof-of-concept data for
drug candidate Alzhemed™ for Alzheimer's Disease. Submission to Regulatory Authorities for Phase II Study Scheduled for Q2 2002
Neurochem is actively preparing for a Phase II clinical trial to assess the safety and
efficacy of Alzhemed™ in patients suffering from mild-to-moderate Alzheimer's Disease.
The Phase II protocol, as designed by the Company and in consultation with its Clinical
Advisory Board, includes a multicenter, randomized, double-blind, parallel and placebo study
with approximately 450 patients to be enrolled in 35 centers in the U.S and Canada. The
submission to the regulatory authorities is expected during Q2 2002. Newly Released Preclinical Data for Alzhemed™ from Proof-of-Concept Studies in Transgenic Animal Model
The Company presented newly released data showing that Alzhemed™ significantly
reduced the amount of toxic amyloid in the brain of transgenic mice treated at the
onset of plaque formation. The preclinical study indicates that Alzhemed™ was found
to significantly reduce the amount of total Aß concentration in the brain when
administered at an early stage of the disease. The drug candidate was also found to
significantly decrease brain and plasma soluble Aß, as well as reduce the
accumulation of the characteristic toxic amyloid fibril deposits in the brain. These
results suggest that Alzhemed™ may have important implications as a new class of
disease-modifying drugs for the treatment of Alzheimer's Disease. About Alzhemed™
Alzhemed™ is a small sulfonated molecule that has been specifically designed to
interfere with the association of glycosaminoglycans with the Aß amyloidogenic
protein, leading to the expected inhibition of the formation and the deposition of
amyloid fibrils in the brain of Alzheimer's Disease patients. Alzhemed™'s
anti-amyloid effectiveness has been demonstrated in an aggressive transgenic mouse
model of brain amyloid with a significant 61% reduction in Aß plasma levels and
a 30% reduction in Aß brain soluble and insoluble fractions after only 8 weeks of
treatment. About Neurochem
Neurochem is an industry leader in the development of therapeutic drugs and diagnostic
tools for central nervous system and amyloid-related diseases associated with aging. The
Company has built a strong product pipeline by developing a novel, proprietary series of
compounds that inhibit the formation, deposition and toxic effects of amyloid fibrils within
the body. Neurochem's therapeutic programs target Alzheimer's Disease, Hemorrhagic Stroke
(due to Cerebral Amyloid Angiopathy), Secondary Amyloidosis, Diabetes Type II and Epilepsy.
Neurochem is using a multi-pronged approach towards the development of pharmaceuticals for
Alzheimer's Disease, including glycosaminoglycans (GAGs) mimetics, a vaccine, an
anti-inflammatory and neuroprotective approaches as well as the development, in collaboration
with Amersham Health, of a diagnostic imaging tool. The Company has advanced to date three
drug candidates to clinical trials: Alzhemed™, for the treatment of Alzheimer's Disease,
Fibrillex™, for the orphan disease Secondary Amyloidosis, and Cerebril™, for
Hemorrhagic Stroke. At present, the Company employs over 76 people and is located in
Saint-Laurent, Canada (www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which
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: |
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