SAN DIEGO, Calif., Jul 19 (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.
