Drug News Brief: Bapineuzumap Trial Drops Highest Dose
2 April 2009. Elan and Wyeth announced today that two ongoing Phase 3 clinical trials of bapineuzumab will discontinue the highest planned dose of 2 mg/kg. This change was made to reduce risk for vasogenic edema, a swelling of the brain related to changes in blood vessels. It is not entirely clear how clinically dangerous this side effect is, but Alzheimer disease researchers generally believe that it is related to the antibody’s mechanism of action. According to wire stories, this change affects the trials in people who do not carry an ApoE4 allele. It will reduce the size of the trials slightly, and people already randomized to the highest dose will be able to move to the 1 mg/kg or 0.5 mg/kg arms. The trials in ApoE4 carriers are unaffected at this point; they only test a lower dose of 0.5 mg/kg. For more information, see Reuters story and Elan press release. In February 2009, Elan announced various cost-cutting measures, including layoffs in Ireland and the U.S. and reduced pay for some of its senior executives.—Gabrielle Strobel.