EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene® (histamine dihydrochloride). Ceplene® is EpiCept’s novel therapeutic candidate for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission, which was approved in the European Union in 2008 and is co-administered with low-dose interleukin-2 (IL-2).

In its preliminary review of the Ceplene® NDA, the FDA concluded that the application did not establish Ceplene’s therapeutic contribution in its combination with IL-2, and recommended that an additional confirmatory pivotal trial assessing Ceplene’s contribution and using overall survival as a primary endpoint be conducted.

EpiCept intends to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission. The Company retains the right to file the NDA over FDA objections.

“We are surprised and obviously very disappointed by the FDA’s decision on our application,” commented Jack Talley, President and Chief Executive Officer of EpiCept. “The Ceplene/IL-2 regimen, which is being rolled out to patients in the European Union, is the only approved treatment that has been shown to prevent relapse of AML patients, of whom the majority will die within a year should a relapse occur. We believe that the results of the Ceplene® Phase III AML study, which demonstrated a statistically significant improvement in leukemia free survival without impacting patients’ quality of life and no treatment related mortality, together with the supporting data we generated for the application deserved a detailed review. In addition, six randomized large scale studies have shown that IL-2 alone is not an effective therapy for AML patients. We will meet with the FDA as soon as possible to explore whether a basis exists to resubmit the application without conducting a new clinical trial.”