EpiCept, FDA reach agreement on regulatory path forward for Ceplene

“We are committed to Ceplene® as an important medical breakthrough that needs to be available to AML patients in the United States as it is currently in Europe”

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that it has reached an agreement on all outstanding issues with the U.S. Food and Drug Administration (FDA) on a regulatory path forward for Ceplene® (histamine dihydrochloride), the Company's lead product for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission. Ceplene® is approved in the European Union for this indication and is marketed there by Meda AB.

The FDA indicated that a new trial should be conducted to demonstrate Ceplene's activity in conjunction with low-dose interleukin-2 (IL-2) as remission maintenance therapy for AML patients in first complete remission. EpiCept has reached agreement with the FDA for a two-arm, randomized, open-label trial that will compare the efficacy of Ceplene® plus low-dose IL-2 to standard of care in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. The Company's previous Phase III trial demonstrated a statistically significant prolongation of the primary endpoint of leukemia-free survival and extended overall survival by more than one year in patients in their first complete remission.

As a next step, EpiCept will submit a detailed Phase III protocol. The FDA, via the Special Protocol Assessment (SPA) procedure, will provide guidance on specific sections of the protocol including the adaptive design with prospectively defined rules for sample size selection for both futility and expected success. The Company also recently filed an application with the FDA to grant Ceplene® fast track status. In addition to other benefits, if granted, this should permit an expedited review of the Ceplene® New Drug Application (NDA) once it is filed.

"We are committed to Ceplene® as an important medical breakthrough that needs to be available to AML patients in the United States as it is currently in Europe," said Jack Talley, President and Chief Executive Officer of EpiCept. "We intend to work closely with the FDA to produce an optimal trial design that is achievable and can be conducted in a reasonable timeframe. The framework under which we are working with the FDA provides us with a realistic pathway to conduct the study ourselves or with a partner. We will now determine the appropriate next steps for funding and conducting this trial, with the intent of commencing such a study in 2011."