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This excerpt taken from the ELN 20-F filed Feb 28, 2008. Bapineuzumab
(AAB-001) and AAB-002 with Wyeth
Bapineuzumab (AAB-001) is an experimental humanized monoclonal
antibody delivered intravenously that is being studied as a
potential treatment for mild to moderate Alzheimer’s
disease. Bapineuzumab is thought to bind to and clear beta
amyloid peptide in the brain. It is designed to provide
antibodies to beta amyloid directly to the patient, rather than
requiring patients to mount their own immune responses.
Bapineuzumab has received fast-track designation from the FDA,
which means that it may receive expedited approval in certain
circumstances, in recognition of its potential to address the
significant unmet needs of patients with Alzheimer’s
disease.
In May 2007, Elan and Wyeth announced the decision to initiate a
Phase 3 clinical program for bapineuzumab. The Phase 3 program
encompasses studies in North America and the rest of the world
(ROW). In December 2007, we announced that the first patient had
been dosed in the studies taking place in North America. It is
expected that the ROW studies will begin enrolling patients
during the first half of 2008.
The Phase 3 program includes four randomized, double-blinded,
placebo controlled studies across two subpopulations, which are
designed to total approximately 4,000 patients with mild to
moderate AD at approximately 350 sites. The treatment duration
for each patient is 18 months with patients to be equally
distributed between North America and the rest of the world. The
studies stratify patients by ApoE4 genotype, and all studies
have co-primary efficacy end points — one cognitive
and one functional.
Two Phase 2 studies of bapineuzumab remain ongoing and are
expected to be completed in 2008. Both studies are randomized,
double-blind, placebo-controlled, multiple ascending dose
studies with four dose cohorts. The main Phase 2 study enrolled
approximately 240 patients, and the other enrolled
approximately 30 patients and included a beta amyloid
imaging component. Both studies are being conducted in patients
with mild to moderate Alzheimer’s disease. The patients are
being followed for 18 months. Data from the Phase 1
clinical study presented in 2006 showed a statistically
significant improvement, compared to placebo, on a key measure
of cognitive function: the Mini-Mental State Examination.
In addition to the intravenous formulation of bapineuzumab, a
subcutaneous formulation of this antibody is in Phase 1 clinical
trials, and AAB-002, a
back-up
compound to bapineuzumab, is in the preclinical phase.
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