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Maxim withdraws Ceplene NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Maxim is withdrawing the NDA for use of its H2 receptor antagonist Ceplene (histamine dihydrochloride) in malignant melanoma patients with liver metastases, the firm announces Nov. 1. "Our focus has shifted to potential filings for…acute myeloid leukemia based on our positive Phase III trial reported this summer, as well as partnering efforts for both Ceplene and our apoptosis compounds," Maxim says. Negative results for a confirmatory Phase III trial in advanced malignant melanoma were reported in September; the company said it would evaluate whether to pursue the indication (1Pharmaceutical Approvals Monthly Oct. 1, 2004, In Brief)...

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FDA's request for another Phase III trial for Maxim's Ceplene for acute myeloid leukemia means the company will need a corporate partner, the firm says Jan. 18. The immunomodulator met the primary endpoint of leukemia-free survival in combination with interleukin-2 in the prior 320-patient Phase III study. Maxim withdrew its first NDA for Ceplene, for malignant melanoma (1Pharmaceutical Approvals Monthly Nov. 1, 2004, In Brief). Maxim remains in discussions with FDA regarding trial design, and is discussing the need for another AML trial with European regulators...

Maxim Ceplene fails melanoma study

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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