Elan and Wyeth to Take Alzheimer's Drug to Phase III
Posted on: Monday, 21 May 2007, 12:00 CDT
Elan Corporation and Wyeth Pharmaceuticals have decided to initiate a phase III clinical program of bapineuzumab, for the treatment of patients with mild to moderate Alzheimer's disease.
The companies said that the decision was based on a scheduled interim look at data from an ongoing phase II study, which remains blinded. No conclusion about the phase II study can be drawn until the study is completed and the final data are analyzed and released in 2008.
The phase III clinical trial design will be finalized with regulatory agencies, and subject to regulatory approval, it is intended for the trial to begin in the second half of 2007.
Bapineuzumab is a humanized monoclonal antibody that received Fast Track designation from the FDA for treatment of mild to moderate Alzheimer's disease, which is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities.
Source: Datamonitor
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