FDA says Ceplene for AML needs additional data
San Diego-based Maxim Pharmaceuticals has admitted that based on ongoing correspondence with the FDA, as well as consultations with external advisors, an additional Phase III clinical trial will be necessary to further evaluate Ceplene plus Interleukin-2 (IL-2) combination therapy for the treatment of acute myeloid leukaemia (AML) patients in complete remission before applying for regulatory approval in the United States.
San Diego-based Maxim Pharmaceuticals has admitted that based on ongoing correspondence with the FDA, as well as consultations with external advisors, an additional Phase III clinical trial will be necessary to further evaluate Ceplene plus Interleukin-2 (IL-2) combination therapy for the treatment of acute myeloid leukaemia (AML) patients in complete remission before applying for regulatory approval in the United States.
In May 2004 Maxim announced that its Phase III clinical trial studying Ceplene plus IL-2 therapy in 320 AML patients in complete remission met its primary endpoint, improvement in leukaemia-free survival. Maxim will continue discussions with the FDA regarding trial design, however, given the time and costs required to conduct another Phase III clinical trial, the company believes that such trial would need to be done in collaboration with a corporate partner, and Maxim intends to pursue partnering opportunities in the United States related to Ceplene for the treatment of AML. Maxim is continuing discussions with European regulators to determine if an additional Phase III clinical trial is necessary for European regulatory approval.