BioCentury
ARTICLE | Clinical News

Ceplene histamine dihydrochloride: FDA action

September 19, 2011 7:00 AM UTC

According to EpiCept, FDA indicated the biotech should compare Ceplene plus IL-2 vs. IL-2 monotherapy using OS as the primary endpoint as part of a registration trial in order to isolate the effect of Ceplene from IL-2. The agency recommended both arms receive the same IL-2 dosing regimen and said LFS can be a secondary endpoint in the trial as long as bone marrow samples are collected at pre-specified and regular intervals during the trial. EpiCept said it plans to submit an SPA to FDA for the trial "as soon as possible."

In June, FDA requested the company include the IL-2 monotherapy arm in the trial after 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. The agency's previous position did not include the IL-2 monotherapy arm (see BioCentury, July 4). ...