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news.EpiCept has provided an update on the post-approval commitments requested by the European Medicines Agency (EMA) as part of its marketing authorisation for Ceplene (histamine dihydrochloride).
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EpiCept said that Ceplene is approved in the EU for remission maintenance and prevention of relapse in adults with acute myeloid leukemia (AML) in first complete remission.
EMA has accepted the conclusion of EpiCept that it is not feasible to conduct 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, in conjunction with cooperative groups in Europe and/or the US. As a result, the EMA now considers this post-approval commitment fulfilled.
A new clinical study of Ceplene/IL-2 in remission maintenance for AML versus a comparator without demonstrated efficacy would raise ethical and practical issues in obtaining required study approvals from institutional ethics committees and institutional review boards.
EpiCept is continuing enrollment in its post-approval clinical trial studying the effects of remission maintenance therapy with Ceplene/IL-2 on minimal residual disease (MRD) in adult patients with AML in first complete remission.
The open-label, multicenter study is also assessing the quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 by monitoring T-cell and natural killer cell phenotypes and their functionality after the first and third treatment cycles.
The study is expected to enroll up to 150 patients at approximately 30 centers across Europe with sites in Sweden, Belgium, France, the UK, Spain and Italy.
Jack Talley, president and CEO of EpiCept, said: “We are pleased that EMA officials have agreed that obtaining data from a new confirmatory study versus a comparator with unproven efficacy was not feasible.
“We intend to inform other regulatory authorities, including Health Canada and the FDA, of the EMA’s conclusion during their respective reviews of the Ceplene application for marketing approval. We expect to complete the post-approval trial with Ceplene in 2011 and remain on track with our plans to submit a New Drug Application to the FDA during the current quarter.”