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Neurochem
Inc. has filed an Investigational New Drug application with the
U.S. Food and Drug Administration in preparation for starting
a phase II clinical trial of Alzhemed, a drug designed to
modify the course of Alzheimer's disease.
Researchers
say Alzhemed in mouse trials has both prevented and stopped formation
of amyloid fibrils in the brain and inhibited the inflammatory
response associated with amyloid build-up in Alzheimer's disease.
A total of
48 patients with mild to moderate Alzheimer's are expected to
participate in the multicenter phase II trial designed to determine
optimal dosing regimens for Alzhemed.
"The
IND filing for the initiation of Phase II trials for Alzhemed
is an
important milestone within our Alzheimer's disease program,"
said Dr. Louis R. Lamontagne, President and CEO of Neurochem.
"Our
objective is to optimize the subsequent North American efficacy
trials based on the results obtained in this Phase II clinical
study."
Other
sources: Neurochem
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