Rethinking Phase II in Antril's wake

By Karen Bernstein Editor-in-ChiefThe dramatic difference between the results of Synergen Inc.'s Phase II and Phase III Antril trials, while pointing up the difficulty of conducting sepsis trials, also raises a general question as to whether companies should take more time in Phase II in order to obtain more extensive data before going on to Phase III.

In a report issued Friday, Richard Stover of Stover Haley Noyes wrote that "Antril's development thus far appears to have been inappropriately hurried to satisfy investors." With the benefit of hindsight, Stover said that the Phase II trial wasn't large enough to provide the information necessary to optimally design a pivotal Phase III trial, while the recently completed Phase III trial could more appropriately be termed an elegant Phase II study...