Isavuconazole: Phase III delayed

Basilea and partner Astellas will delay the restart of a halted, double-blind, international Phase III trial comparing isavuconazole vs. voriconazole until year-end or early 2011 from 3Q10. Basilea said the delay will allow the trial, which is designed to enroll a planned 360 patients, to use the compound manufactured at the commercial-scale production line. Basilea said it continues to expect data in 2013. Last year, an independent DSMB recommended continuing the trial after it passed a planned interim futility analysis in the first 180 patients on the primary endpoint of non-inferiority to voriconazole (see BioCentury, Feb. 8). ...