EpiCept's (EPCT) IL-2 Not Effective as AML Maintenance Treatment; New Data Published
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EpiCept Corporation (Nasdaq: EPCT) reports the publication of a new meta-analysis which concluded that interleukin-2 (IL-2) monotherapy is not effective as a maintenance therapy for acute myeloid leukemia (AML) patients in first complete remission. These results were published in the July 7, 2011 edition of Blood, a leading scientific journal in hematology.
Some color from the release: "The analysis appears in an article entitled “Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia,” and was designed to determine the efficacy of IL-2 monotherapy by combining all available individual patient data from five randomized clinical trials and summary data from a sixth trial. The combined individual patient data of 1,455 patients collected over several years showed no benefit of IL-2 compared with standard of care in terms of leukemia free survival (LFS) (p=0.74) or overall survival (OS) (p=0.39). This analysis encompasses all randomized studies examining the role of IL-2 as monotherapy in AML.
The authors highlight the view that the efficacy of IL-2 monotherapy could be hampered by the activity of other immune cells. Several preclinical studies have established a role for Ceplene® (histamine dihydrochloride) to protect the viability and function of anti-leukemic lymphocytes. A Phase III randomized trial of AML patients in complete remission with Ceplene/IL-2 combination therapy resulted in a significant prolongation of LFS (p<0.01) and a trend towards improvement in OS (p=0.12). The authors conclude that the suggestion that IL-2 has the potential to improve LFS and OS in AML may be valid, but for IL-2 to exert a significant clinical effect on relapse prevention in this disease, its activity may need to be protected by Ceplene.
The findings of this meta-analysis provide further evidence of the pivotal role that Ceplene® plays in prolonging LFS in AML patients in first remission when used in conjunction with low-dose IL-2."
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Some color from the release: "The analysis appears in an article entitled “Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia,” and was designed to determine the efficacy of IL-2 monotherapy by combining all available individual patient data from five randomized clinical trials and summary data from a sixth trial. The combined individual patient data of 1,455 patients collected over several years showed no benefit of IL-2 compared with standard of care in terms of leukemia free survival (LFS) (p=0.74) or overall survival (OS) (p=0.39). This analysis encompasses all randomized studies examining the role of IL-2 as monotherapy in AML.
The authors highlight the view that the efficacy of IL-2 monotherapy could be hampered by the activity of other immune cells. Several preclinical studies have established a role for Ceplene® (histamine dihydrochloride) to protect the viability and function of anti-leukemic lymphocytes. A Phase III randomized trial of AML patients in complete remission with Ceplene/IL-2 combination therapy resulted in a significant prolongation of LFS (p<0.01) and a trend towards improvement in OS (p=0.12). The authors conclude that the suggestion that IL-2 has the potential to improve LFS and OS in AML may be valid, but for IL-2 to exert a significant clinical effect on relapse prevention in this disease, its activity may need to be protected by Ceplene.
The findings of this meta-analysis provide further evidence of the pivotal role that Ceplene® plays in prolonging LFS in AML patients in first remission when used in conjunction with low-dose IL-2."
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