EpiCept Corporation announced the start of a post-approval clinical study with Ceplene (histamine dihydrochloride) following Ethics Committee and Competent Authority approvals in Sweden, Belgium, and France. This study will fulfill the post approval commitments requested by the European Medicines Evaluation Agency (EMEA) in granting marketing authorization. Ceplene is indicated for remission maintenance in adult patients with Acute Myeloid Leukaemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2).
This study will enrol up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the UK, Spain and Italy. The two primary objectives are to further demonstrate the clinical pharmacology of Ceplene by assessing certain immunologic biomarkers in AML patients in first remission, and to measure the effect of Ceplene/IL-2 on minimal residual disease in the same patient population. Secondary objectives will assess leukaemia-free survival after a follow-up period of up to two years. EpiCept expects the study will take approximately three years to complete.
"We are pleased to begin this study under the leadership of study chair and principal investigator Dr Robin Foa in Rome, Italy and co-principal investigator Dr Mats L Brune in Gothenburg, Sweden and to be working closely with a broad network of haematology thought leaders," stated Jack Talley, president and chief executive officer of EpiCept. "The commencement of this trial meets our post-approval commitment to the EMEA and underscores our determination to move forward as quickly as possible with the commercial launch of the drug in the European Union. Ceplene is an important therapy for AML patients because it is the only medical therapy ever proven to prevent relapse in this deadly disease."
Ceplene is EpiCept's proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission.
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain.