In reaching this opinion, the European Committee for Medicinal Products for Human Use (CHMP) stated that further data are required to support the results from EpiCept’s Phase III clinical study of Ceplene. The CHMP indicated that data from the single pivotal acute myeloid leukemia (AML) trial was not adequately statistically compelling. Specifically, the CHMP seeks additional mechanistic data on Ceplene to elucidate further the pharmacological rationale for the proposed use of Ceplene in conjunction with interleukin-2.
In accordance with the rules governing the European centralized procedure, EpiCept has already requested a re-examination of this opinion through the appeal procedure. No formal decision will be taken by the European Commission, as the European licensing authority, until the appeal procedure has been completed. EpiCept intends to submit a document setting out the ‘detailed grounds for re-examination’ within 60 days of receipt of the negative opinion and expects its appeal proceeding to take place in the third quarter of 2008. Ceplene is designated as an orphan medicinal product in the EU with respect to this indication.
Jack Talley, president and CEO of EpiCept, said: “We remain optimistic that we will be successful in the re-examination of our application and we will continue to be steadfast in our efforts to bring this desperately needed therapy to AML patients in Europe.”