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EpiCept Releases New Data Demonstrating Prolonged Five-Year Leukemia-Free Survival for AML Patients Treated with Ceplene(TM) + IL-2
Date:12/9/2007

se among AML patients. These data were presented by Ana I. Romero from the Department of Internal Medicine, University of Goteborg in a presentation entitled, "Histamine Dihydrochloride Maintains Cytoxic Effector T Lymphocyte Function and Viability under Conditions of Oxidative Stress."

In the study, researchers recovered autoreactive T-cells from AML patients and exposed them to exogenous hydrogen peroxide or oxygen radical-producing mononuclear phagocytes. Ceplene, an inhibitor of oxygen radical formation in phagocytes, completely prevented apoptosis in the T-cell subset (n=8, p<0.0001). In the presence of mononuclear phagocytes, Ceplene synergized with IL-2 in promoting cell cycle proliferation. Based on these findings, researchers concluded that the phenotype of T-cells with spontaneous reactivity against AML blasts is highly sensitive to oxidants and that by inhibiting oxygen radical formation, Ceplene efficiently protects these cytotoxic lymphocytes from apoptosis in an environment of oxidative stress. In addition, Ceplene was shown to synergize with IL-2 to activate and expand these T-cells.

About Ceplene

Ceplene is EpiCept's registration-stage compound for the treatment of AML. 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.

Ceplene Clinical Trial History

A pivotal Phase III study for Ceplene in conjunction with IL-2 was conducted in 11 countries and included 320 randomized patients. This study met its primary endpoint of preventing relapse as shown by increased LFS at three years for AML patients in remission. The data demonstrated that patients with AML in complete remission who received 18 months of treatment with Ceplene plus low dose IL-2 experienced a significantly improved
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SOURCE EpiCept Corporation
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