-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.
((Comments on this story may be sent to firstname.lastname@example.org))
|Printer friendly Cite/link Email Feedback|
|Publication:||Nordic Business Report|
|Date:||Sep 12, 2011|
|Previous Article:||-Diamyd Medical gets USD3m research grant for NTDDS technology.|
|Next Article:||-Skanska to expand motorway in Norway for NOK764m.|