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-Epicept receives FDA guidance on approval pathway for leukaemia drug.

NORDIC BUSINESS REPORT-September 12, 2011--Epicept receives FDA guidance on approval pathway for leukaemia drug(C)2011 M2 COMMUNICATIONS http://www.m2.com

12 September 2011 - Stockholm-listed pharma company Epicept Corp (STO:EPCT; NASDAQ:EPCT) has received more definitive guidance from the US Food and Drug Administration (FDA) regarding a confirmatory Phase III study of Epicept's leukaemia drug Ceplene.

In August 2010, the FDA rejected Epicept's application for marketing approval of Ceplene (histamine dihydrochloride) in combination with low-dose interleukin-2 (IL-2) for the remission maintenance and prevention of relapse in patients with acute myeloid leukaemia (AML) in first complete remission. The authority then recommended an additional pivotal trial to support a resubmission of the application.

In May 2011, Epicept proposed a two-arm trial comparing maintenance therapy with Ceplene and IL-2 to investigator's choice, which is often no treatment.

However, at a recent meeting the FDA recommended that the confirmatory trial isolate the effect of Ceplene from the effect of IL-2 by comparing Ceplene in combination with IL-2 to IL-2 as monotherapy, Epicept said today. In addition, the patients in the IL-2 arm should receive the same IL-2 dose as the patients in the Ceplene/IL-2 arm, according to the authority's guidance. The primary endpoint of the trial should be a significant benefit of Ceplene/IL-2 versus IL-2 monotherapy on overall survival. Leukemia-free survival (LFS) can be a secondary endpoint if bone marrow samples are collected at pre-specified and regular intervals during the trial, Epicept said.

Based on the new guidance, the pharma company plans to prepare and submit a new trial protocol in order to get feedback as soon as possible.

Ceplene has already been approved and is being sold in the European Union (EU) and in Israel.

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Publication:Nordic Business Report
Date:Sep 12, 2011
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