Elan, Wyeth drop highest dose in 2 bapineuzumab trials

Elan Corp. plc (NYSE:ELN) and Wyeth (NYSE:WYE) will discontinue the highest of three dosing regimes, 2 mg/kg, in two ongoing Phase III trials of bapineuzumab in non-carriers of the apolipoprotein E4 allele to treat mild to moderate Alzheimer's disease. The decision comes after a review of vasogenic edema (VE) by an independent safety monitoring committee (SMC) that Elan said "made it clear that continued development of the highest dose was not advisable." The double-blind, placebo-controlled trials will now enroll about 1,000 patients each, down from 1,250, and patients in the 2 mg/kg group will now receive 1 mg/kg bapineuzumab, while new patients will receive either 0.5 or 1 mg/kg. The companies said that in a Phase II trial of the humanized mAb against beta amyloid, VE was observed more frequently in patients who were carriers of the apolipoprotein E4 allele and was more likely to occur at higher doses of bapineuzumab. The companies said two other ongoing studies, which are testing a single 0.5 mg/kg dose of the compound in patients who carry the allele, will continue unchanged (See BioCentury, Aug. 04, 2008). ...