EpiCept Corporation Provides U.S. Regulatory Update for Ceplene® Clinical Development

EpiCept Corporation

earlier today announced that at a recent meeting with the U.S. Food and Drug Administration the Company was provided more definitive guidance regarding the clinical development of Ceplene® (histamine dihydrochloride), the Company's lead product administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia in first complete remission. Ceplene® is approved and being marketed in the European Union by Meda AB and in Israel by Megapharm, Ltd. the meeting, the FDA indicated that as part of a registration study, the effect of Ceplene® must be isolated from the effect of IL-2; therefore the preferred study design will be a comparison of Ceplene®/IL-2 vs. IL-2 monotherapy. Furthermore, the FDA recommended that the patients in the IL-2 monotherapy group receive the same IL-2 dosing regimen as those patients receiving Ceplene®/IL-2 in combination. The FDA reiterated the need to demonstrate a significant benefit of Ceplene®/IL-2 vs. IL-2 monotherapy on overall survival, which needs to be the primary endpoint of the trial. Leukemia-free survival can be a secondary endpoint provided that bone marrow samples are collected at pre-specified and regular intervals during the course of the trial. EpiCept intends to work with key opinion leaders in the preparation of a new trial protocol and will submit the protocol to the FDA in order to receive further guidance and approval for Special Protocol Assessment as soon as possible.