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Maxim Seeks Malignant Melanoma Treatment OK



SAN DIEGO, Calif. (Reuters) - Maxim Pharmaceuticals said Wednesday that it filed a new drug application with federal regulators for approval to market a drug to treat malignant melanoma.

The company filed with the US Food and Drug Administration to market histamine dihydrochloride, or Maxamine, in the United States.

Maxim said there is no effective treatment for advanced malignant melanoma, the most serious form of skin cancer. Current treatments often involve substantial toxicity and side effects, the company said.

Maxim said Phase III clinical trial results of its drug showed that when used in combination with cytokine IL-2, improved survival in patients compared with patients treated with the same dose of IL-2 alone.

The trial results also showed that Maxamine treatment had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved, Maxim said.

Cytokines are hormone-like proteins, secreted by many cell types, which regulate the intensity and duration of immune responses and are involved in cell-to-cell communication.

Maxamine was granted orphan drug status by the FDA in February as an adjunct to cytokine therapy. Orphan drug status provides for US marketing exclusivity for 7 years upon marketing approval by the administration.

(From Yahoo)

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