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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Bapineuzumab
(AAB-001)
Bapineuzumab 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 produce 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 world
(ROW). In December 2007, we announced that the first patient had
been dosed in the studies taking place in North America. ROW
studies, conducted by Wyeth, began enrolling patients in June
2008.
The Phase 3 program includes four randomized, double-blinded,
placebo controlled studies across two subpopulations that are
intended to enroll approximately 4,000 patients with mild
to moderate AD at approximately 350 sites. The treatment
duration for each patient will be 18 months with patients
planned to be distributed between North America and ROW. The
studies stratify patients by ApoE4 genotype and all studies have
co-primary efficacy end points — one cognitive and one
functional. In addition, this trial program will also include
sophisticated imaging and biomarker sub-studies to attempt to
further elucidate the clinical profile of bapineuzumab.
The decision to move to Phase 3 was based on the seriousness of
Alzheimer’s disease and what Elan and Wyeth have learned
from their immunotherapy programs, including a scheduled interim
look at data from the then-ongoing Phase 2 clinical trial.
The main Phase 2 study (#201), which has been completed,
enrolled 234 patients with mild to moderate
Alzheimer’s disease. A second study (#202) enrolled
approximately 30 patients and includes a beta amyloid
imaging component. This study is expected to be completed in the
first half of 2009.
Patients in the main Phase 2 study could qualify to enter an
extension study, which is ongoing.
Table of Contents
The #201 and #202 Phase 2 studies were randomized,
double-blind, placebo-controlled, multiple ascending dose
studies with four dose cohorts. Both studies enrolled patients
with mild to moderate Alzheimer’s disease, with an
18-month
treatment duration.
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