Pharmaceutical company EpiCept Corp. (EPCT) said the U.S. FDA indicated that the company had necessary pivotal data to file a New Drug Application, or NDA, for Ceplene in combination with interleukin-2 as a remission maintenance treatment of acute myeloid leukemia.

The company noted that at a pre-NDA meeting last week, the U.S. regulatory body issued guidance that it would accept the clinical data along with other analyses, a few of which had been submitted as part of the Ceplene Marketing Authorization Application, which was approved in Europe in October 2008.

Earlier, in December 2008, EpiCept announced the receipt of a permission from Health Canada to carry on with a New Drug Submission, or NDS, filing for Ceplene to treat acute myeloid leukemia, or AML. Decisions by regulators on both NDS and NDA are anticipated in 2010.

Jack Talley, president and chief executive officer of EpiCept, commented, “We are pleased with the outcome of the pre-NDA meeting. We will be turning our immediate attention to assessing the requirements to submit the NDA in the shortest timeframe possible so as to not deny this unique therapy to AML patients. We are targeting filing the NDA in the second half of 2009.”

Ceplene is EpiCept’s proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission. It is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells.

EPCT closed Friday’s regular session at $0.77, up $0.05 or 6.94%, on a volume of 61 thousand shares.