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This excerpt taken from the ELN 20-F filed Feb 28, 2008. ELND005
with Transition
In 2006, we entered into an exclusive, worldwide collaboration
with Transition for the joint development and commercialization
of a novel therapeutic agent for Alzheimer’s disease.
The molecule, ELND005, is a
beta-amyloid
anti-aggregate that has been granted fast track designation by
the FDA. Based upon preclinical data, by blocking the
aggregation of beta amyloid, clearance of amyloid occurs and
plaque build up is prevented. Daily oral treatment with this
compound has been shown to prevent cognitive decline in a
transgenic mouse model of Alzheimer’s disease, with reduced
amyloid plaque load in the brain and increased survival rate of
these animals.
In December 2007, Elan and Transition announced that the first
patient had been dosed in a Phase 2 clinical study. This study
is a randomized, double-blind, placebo-controlled, dose-ranging
study which evaluates the safety and efficacy of ELND005 in
approximately 340 patients with mild to moderate
Alzheimer’s disease. The patients are being followed for
18 months.
In 2007, it was also announced that multiple Phase 1 clinical
studies had been completed that further evaluated the safety,
tolerability and pharmacokinetic profile of this compound.
ELND005 was found to be safe and well-tolerated at all doses and
dosing regimens examined. No severe or serious adverse events
were observed. ELND005 was also shown to be orally bioavailable,
cross the blood-brain barrier and achieve levels in the brain
and cerebral spinal fluid shown to be effective in animal models
of Alzheimer’s disease.
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