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EpiCept Reports Regulatory Progress on Ceplene(TM)
Date:9/17/2007

Application for AML Remission Maintenance Therapy

Advances on Schedule Following Meeting with EMEA

TARRYTOWN, N.Y., Sept. 18 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today reported that the assessment of its European Union centralized marketing authorization application for its lead oncology product Ceplene(TM) is advancing according to the anticipated regulatory timetable following a meeting yesterday. Ceplene (histamine dihydrochloride) has demonstrated important clinical benefit in the maintenance of remission for patients with Acute Myeloid Leukemia (AML).

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EpiCept's Marketing Authorization Application (MAA) for Ceplene has reached the next important step in its assessment by the Committee for Human Medicinal Products (CHMP). Specifically, EpiCept submitted full responses to the Day 120 Consolidated List of Questions. EpiCept's staff and expert consultants met on September 17 with EMEA officials and CHMP representatives to discuss these responses. Included with the Day 120 response documentation, EpiCept has provided data on Ceplene's effect on quality of life and on long term follow up of at least five years on leukemia-free survival for AML patients.

"We are pleased to have reached the latest regulatory milestone for Ceplene in the EU, and to be closer to our goal of providing hematologists with the first remission maintenance immunotherapy for AML patients," stated Jack Talley, President and Chief Executive Officer of EpiCept. "EpiCept outlined to the EMEA and CHMP representatives how the data package for Ceplene supports approval. We look forward to working with the regulators to complete their assessment. We are enthusiastic about the potential of Ceplene, which in our pivotal trial increased the long-term, disea
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