EpiCept Corporation announced that it has received initial written responses from the US Food and Drug Administration (FDA) regarding the company's application for a Special Protocol Assessment (SPA) of the Ceplene (histamine dihydrochloride) phase III protocol. Ceplene, which is administered in conjunction with low-dose interleukin-2 (IL-2), is EpiCept's maintenance therapy for patients with Acute Myeloid Leukaemia (AML) in first remission. Among those responses, the FDA noted that in contrast to its earlier position it is now proposing that the trial attempt to isolate Ceplene's effect by including an IL-2 monotherapy arm in the trial protocol. The FDA has invited the company to request a meeting to discuss its responses to the company's application.

In its initial protocol submission, EpiCept proposed a two-arm trial comparing the efficacy of maintenance therapy with Ceplene in conjunction with IL-2 to investigator's choice, which is often no treatment.

EpiCept intends to meet with the FDA as soon as possible to reconcile this response with the position taken at its meeting with the Company in October 2010 in which an IL-2 monotherapy arm was not part of the agreed-upon trial design, and to discuss other responses to the SPA application. The company retains the right to appeal any decision by the FDA's office of oncology drug products.

EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain.