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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

chloride and Interleukin-2 in AML: Long Term Follow-Up of Leukemia-Free Survival and Overall Survival."

The data were derived from an analysis of the long-term outcomes of AML patients enrolled in the pivotal Phase III Ceplene study, which met its primary endpoint of increased LFS (p <0.01) among AML patients in remission. The objective of the five-year analysis was to assess the durability of the LFS benefit of post-consolidation immunotherapy with Ceplene + IL-2.

The median LFS of AML patients in first remission was 15 months for the Ceplene + IL-2 group versus 9.7 months in the control group (P=0.025). A Kaplan-Meier five-year estimate was supportive of the effect of Ceplene + IL-2 in maintaining LFS. In the AML population in first remission, this effect was shown in 34 percent of the treatment group versus 22 percent of the control group (P=0.024). Further, the median duration of the overall survival rate in the first remission patient group was 44 months for the Ceplene + IL-2 group versus 29 months for the control group, an improvement of 15 months. The Kaplan-Meier estimate analysis of patients alive at five years show a strong trend in favor of Ceplene + IL-2 (Kaplan-Meier, P=0.07), even though the trial was not initially powered to demonstrate a benefit in overall survival.

Dr. Brune stated, "The effect of a combined therapy of Ceplene + IL-2 in prolonging leukemia-free survival and in preventing relapse was both durable and statistically significant. These results indicate that Ceplene, if approved, could provide important therapeutic benefits to AML patients, for whom there are currently no available treatment options shown to increase leukemia-free survival."

Additional Ceplene Study Results Presented

In a separate poster presentation given yesterday at ASH, EpiCept provided new study results regarding the mechanisms of action relevant to Ceplene's demonstrated ability in combination with IL-2, to prevent leukemic relap
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SOURCE EpiCept Corporation
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