Maxim Reports that Additional Phase 3 trial of Ceplene™ therapy in the treatment of acute myeloid leukemia patients in complete remission will be required by the fda

Company Continuing Discussions with European Regulators Regarding AML Application

SAN DIEGO, Calif., January 18, 2005 -- Maxim Pharmaceuticals, Inc. (NASDAQ: MAXM, SSE: MAXM) today announced that based on ongoing correspondence with the United States Food and Drug Administration (FDA), as well as consultations with external advisors, an additional Phase 3 clinical trial will be necessary to further evaluate Ceplene plus Interleukin-2 (IL-2) combination therapy for the treatment of acute myeloid leukemia (AML) patients in complete remission before applying for regulatory approval in the United States. In May 2004 Maxim announced that its Phase 3 clinical trial studying Ceplene plus IL-2 therapy in 320 AML patients in complete remission met its primary endpoint, improvement in leukemia-free survival. Maxim will continue discussions with the FDA regarding trial design, however, given the time and costs required to conduct another Phase 3 clinical trial, the Company believes that such...

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