4 April 2009

Highest dose of bapineuzumab discontinued in non-carrier trials

Elan and Wyeth Plan to Amend Bapineuzumab Phase 3 Protocols
Elan: 2 April 2009
Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE) today announced that the companies will discontinue the highest of three dosing regimens, 2.0 mg/kg, in the two ongoing Phase 3 studies of bapineuzumab in patients with mild to moderate Alzheimer’s disease (AD) who do not carry the Apolipoprotein E4 (ApoE4) allele (non-carriers). ApoE4 is a known genetic risk factor for development of AD. The 0.5 mg/kg and 1.0 mg/kg doses in these two trials will continue as planned.

This decision has no impact on two other ongoing studies, which are testing a single 0.5 mg/kg dose of bapineuzumab in patients who carry the ApoE4 allele (carriers). No changes are planned for these two carrier studies. The Phase 3 program for bapineuzumab is the largest clinical program ever initiated in Alzheimer’s disease. It is expected that approximately 4,000 patients will be included across all four studies. … > full press release

Related information:
Bapineuzumab Phase 3 Protocol Amendment Q&A
  • Highest Dose of Bapineuzumab Discontinued in Non-Carrier Trials
  • ICAD: Post Hoc Analysis Finds Silver Lining in Bapineuzumab Failed Trial
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