EpiCept Releases New Data Demonstrating Long-Term Durability Of Ceplene In Sustaining Leukemia-Free Survival

Main Category: Lymphoma / Leukemia / Myeloma
Article Date: 05 Jun 2009 - 5:00 PDT

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EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) has released new long-term data showing that the use of Ceplene® when administered in conjunction with low-dose interleukin-2 (IL-2) provides durable protection from leukemia relapse in patients with Acute Myeloid Leukemia (AML), based on a minimum of six years of follow-up. These data will be presented on June 6, 2009 at the European Hematology Association's (EHA) 14th Congress in Berlin, Germany.

The presentation entitled "Six-Year Outcomes Update from a Randomized Phase 3 Trial in AML: Durable Effect of Remission Maintenance Immunotheraphy with Histamine Dihydrochloride and low-dose IL-2" was authored by Dr. Mats Brune, MD and co-workers.

Researchers analyzed follow-up data from patients enrolled in the Phase III pivotal trial of Ceplene®. The primary endpoint assesses the durability of the benefit of Ceplene® with IL-2 in achieving leukemia-free-survival (LFS), after a minimum of six years, in patients who have achieved first complete remission (CR1) and among the overall patient group. The study found that the Ceplene®/IL-2 treatment group continued to show statistically significant differences in LFS in the overall treatment population (p=0.011) and among the CR1 group (p=0.015).

"These data provide further demonstration of the positive and prolonged clinical benefits Ceplene® can provide AML patients in preventing relapse of this deadly disease," remarked Jack Talley, President and CEO of EpiCept. "These findings also represent the latest in a number of significant milestones for Ceplene®, as we just announced that the drug is now available to patients in major markets throughout the world through our named patient program agreement with IDIS. We continue to be keenly focused on further expanding the extraordinary impact that Ceplene® can have on AML patients through our regulatory advancement of the drug in North America."

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.

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EpiCept Corporation