Rethinking Phase II in Antril's wake
By Karen Bernstein
The 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.
While most of the executives who talked to BioCentury said it isn't necessary for companies to spend more time in Phase II, there were a few dissenters.
Typical of those who thought the Antril results don't have broad implications was Sutro & Co. analyst Margaret McGeorge. "I don't think this necessarily has any implications for other trials," she said. "Some conditions can be more easily defined prospectively than others."
Depends on end point

Ted Greene, chairman and CEO of