TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today provided an update on the post-approval commitments requested by the European Medicines Agency (EMA) as part of its marketing authorization for Ceplene® (histamine dihydrochloride). Ceplene is approved in the EU for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia (AML) in first complete remission. The EMA has notified EpiCept that it has accepted the conclusion of a panel of prominent hematologists convened by the Company that it is not feasible to conduct, in conjunction with cooperative groups in Europe and/or the United States, a confirmatory Phase III study to evaluate the safety and efficacy of Ceplene with low-dose interleukin-2 (IL-2) versus a comparator arm of either no treatment or IL-2 alone. As a result, the EMA now considers this post-approval commitment fulfilled.
