FDA REQUIRES ADDITIONAL PHASE III TRIAL OF CEPLENE THERAPY FOR ACUTE MYELOID LEUKEMIA PATIENTS IN COMPLETE REMISSION

Maxim Pharmaceuticals has announced that, based on ongoing correspondence with the FDA as well as consultations with external advisers, 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 leukemia (AML) patients in complete remission before applying for regulatory approval in the U.S.

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 leukemia-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 a trial would need to be done in collaboration with a corporate partner, and Maxim intends to pursue partnering opportunities in the U.S. 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. The company will continue to evaluate strategic options related to the above outcomes.