Non-binding EMEA opinion for EpiCept's Ceplene

USA-based EpiCept says that it recently presented at the oral explanation meeting to the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), regarding the remaining outstanding issues on the Marketing Authorization Application for Ceplene (histamine dihydrochloride), which is intended to be indicated for the maintenance of remission and prevention of relapse of patients with acute myeloid leukemia in first remission. Ceplene was designated an orphan medicinal product in the European Union on April 11, 2005, in respect of this indication.

However, a non-binding trend vote taken after the meeting indicated that a slight majority of the votes by CHMP members was not in favor of recommending a positive opinion. The majority view considered that the data presented in the application, while supportive of the product's efficacy and safety in AML, the indication for which approval was sought, should be confirmed by further clinical data from an additional, replicate study. Discussions by CHMP members of the MAA noted findings from a 2003 study of Ceplene/interleukin-2 (at a higher dose) in malignant melanoma, in which Ceplene failed to meet its primary endpoints. By contrast, AML patients in first remission have a microscopically and cytogenetically undetectable tumor burden (minimal residual disease) and are ideal candidates for Ceplene/IL-2 immunotherapy, EpiCept noted.