EpiCept Initiates Post-Approval Clinical Study With Ceplene(R)

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jul 2009 - 5:00 PDT

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EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today 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 Leukemia (AML) in first remission. Ceplene®is to be administered in conjunction with low-dose interleukin-2 (IL-2).

This study will enroll up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the U.K., 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 leukemia-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 hematology 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."

About Ceplene®

Ceplene® is EpiCept's proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission. Ceplene® is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene® reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells. In October 2008 Ceplene® received full marketing approval in the European Union for maintenance therapy and prevention of relapse in adult patients with AML in first remission.

Source
EpiCept Corporation