Medical Letter on the CDC & FDA
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Acute Myeloid Leukemia
Pharma company says additional trial necessary for Ceplene plus Interleukin-2
February 20th, 2005
Maxim Pharmaceuticals, Inc., (Nasdaq:MAXM)(SSE:MAXM) announced that based on ongoing correspondence with the U.S. 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...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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