Ceplene histamine dihydrochloride: SPA amended

EpiCept said FDA requested the company include an IL-2 monotherapy arm in a planned open-label Phase III trial as part of an application for an SPA. In May, EpiCept submitted a protocol to FDA to request an SPA for the trial comparing Ceplene plus low-dose IL-2 vs. investigator's choice of treatment in AML patients in first remission who have received consolidation therapy. EpiCept said it plans to meet with FDA to reconcile the request with the agency's previous position, which did not include the IL-2 monotherapy arm. ...