Elan and Wyeth to Initiate Phase 3 Clinical Trial of Bapineuzumab (AAB-001) in Alzheimer's Disease
DUBLIN, Ireland & Madison, N.J. Elan Corporation, plc (NYSE: ELN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the decision to initiate a Phase 3 clinical program of their lead immunotherapeutic candidate, Bapineuzumab (AAB-001), for the treatment of patients with mild to moderate Alzheimer's Disease. This decision was based on the seriousness of the disease and the totality of what the companies have learned from their immunotherapy programs, including a scheduled Interim look at data from an ongoing Phase 2 study, which remains blinded. No conclusion about the Phase 2 study can be drawn until the study is completed and the final data are analyzed and released in 2008. Phase 3 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.
It is important to remember that Alzheimer's disease is a complex and formidable challenge, and our immunotherapeutic programs still contain inherent risks.
About Bapineuzumab
Bapineuzumab (AAB-001) is a humanized monoclonal antibody that received Fast Track designation from the United States Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast Track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life threatening conditions.
There are two ongoing Phase 2 studies with Bapineuzumab. The first Phase 2 trial is a randomized, double-blind, placebo controlled, multiple ascending dose study of 4 cohorts of the approximately 240 total patients with mild to moderate Alzheimer's disease. The primary objective of the trial is to assess the safety of bapineuzumab. Assessments of cognitive and functional status are also being made in the trail, and each patient's participation lasts approximately 18 months. The key end-points include: ADAS-Cog (assesses cognition), Neuropsychological Test Battery (NTB) and DAD score (measures quality of life). The second Phase 2 trial is an Alzheimer's beta-amyloid imaging study in 30 patients and is being conducted in Europe. The companies do not expect that any Phase 2 data will be released into the public domain until the completion of the Phase 2 trials in 2008.
About Alzheimer's Disease
Alzheimer's disease 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. As Alzheimer's progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans and more than 24 million people worldwide have Alzheimer's disease (Source: Alzheimer's Association and Alzheimer's Disease International)
About the Elan and Wyeth Collaboration
The Elan and Wyeth Alzheimer's Immunotherapy Program (AIP) is a 50:50 collaboration to research, develop and commercialize an immunotherapeutic approach that may be used for the treatment of mild to moderate AD and possibly to prevent the onset of the disease. Current AIP programs include bapineuzumab (AAB-001), AAB-001 SubQ, ACC-001 and AAB-002. Wyeth and Elan equally share all costs and potential revenues from this collaboration. |
