EpiCept announces FDA's feedback on Ceplene clinical development for AML

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and Nasdaq: EPCT) today announced that at a recent meeting with the U.S. Food and Drug Administration (FDA) 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 (AML) in first complete remission. Ceplene^® is approved and being marketed in the European Union by Meda AB and in Israel by Megapharm, Ltd.

At 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 (LFS) 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.

EpiCept President and CEO Jack Talley commented, "We appreciate the input received from the FDA, which outlined a clear path for the registration of Ceplene^® in the U.S. We will incorporate the FDA's feedback in the design of a new pivotal clinical study with appropriate treatment arms and endpoints, such that, assuming a positive trial result, only one new pivotal study will be sufficient to support the submission of a new drug application."