$EPCT Receives Initial FDA Comments on Application for Ceplene(R) Special Protocol Assessment

EpiCept Corporation (nasdaq and nasdaq omx stockholm exchange:EPCT) today announced that it has received initial written responses from the U.S. Food and Drug Administration (FDA) regarding the Company's application for a Special Protocol Assessment (SPA) of the Ceplene(R) (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 leukemia (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.

source: http://www.marketwatch.com/story/epicept-receives-initial-fda-comments-on-application-for-ceplener-special-protocol-assessment-2011-06-27?reflink=MW_news_stmp