Ongoing trails testing highest dose of experimental Alzheimer's drug bapineuzumab stopped

Elan and WyethElan Corp., Plc. and Wyeth decided to stop the ongoing clinical trails testing effect of 2.0 mg/kg dose of experimental Alzheimer's drug bapineuzumab.

Officials from both companies declared the discontinuation of the highest of the 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, or AD, who do not carry the Apolipoprotein E4, or ApoE4, allele. However testing of the 0.5 mg/kg and 1.0 mg/kg doses in two Phase III trials will continue as planned.

The decision to stop the trails of the highest dose was taken after review conducted by the independent Safety Monitoring Committee, or SMC revealed cases of vasogenic edema, or fluid build-up in the brain.

Carlos Paya, Elan's President said, "Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable. The decision to remove the highest dose from development reduces risk to patients and it also helps to reduce risk to the overall development effort."