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news.The US Food and Drug Administration (FDA) has provided a definitive guidance regarding clinical development of EpiCept's Ceplene (histamine dihydrochloride).
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Ceplene is administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission.
The FDA indicated that the patients in the IL-2 monotherapy group receive the same IL-2 dosing regimen as those patients receiving Ceplene/IL-2 in combination.
The primary endpoint of the trial is indicated on overall survival benefit of Ceplene/IL-2 vs. IL-2 monotherapy.
Leukemia-free survival (LFS) can be a secondary endpoint provided that bone marrow samples are collected at pre-specified and regular intervals during the course of the trial.
EpiCept president and CEO Jack Talley said they will incorporate the FDA’s feedback in the design of a new pivotal clinical study with appropriate treatment arms and endpoints, such that, assuming a positive trial result, only one new pivotal study will be sufficient to support the submission of a new drug application.