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Maxim Ceplene fails melanoma study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Maxim is deciding whether to pursue a malignant melanoma indication for Ceplene (histamine dihydrochloride) after the H2 receptor agonist failed a confirmatory Phase III trial for the indication, the company says Sept. 20. The 230-patient trial was conducted under a special protocol assessment and evaluated Ceplene in combination with interleukin-2 against IL-2 alone. Ceplene was not significant for the primary endpoint of duration of survival. Maxim will continue pursuit of an acute myeloid leukemia indication for Ceplene based on positive results from a three-year Phase III trial of Ceplene in combination with IL-2. "We will also conduct a review of our pipeline, our operations and resources," the firm said...
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