SciClone and Sigma-Tau have reported interim Phase II findings for their advanced malignant melanoma drug. The companies are testing Zadaxin in a trial that is evaluating the drug in combination with dacarbazine chemotherapy with and without low-dose interferon alpha to treat patients with Stage IV malignant melanoma, the most advanced and lethal form of the disease.
Sigma-Tau has provided data from the trial showing a distinct Zadaxin dose-dependent response in the drug combination being studied. Specifically, 270 out of the 320 Stage IV malignant melanoma patients enrolled in four treatment arms have been evaluated for both complete and partial tumor response.
In each of the three groups of Zadaxin-treated patients, a higher response rate was observed compared to the control arm, or 12.9 percent of the patients treated with 3.2 mg of Zadaxin in combination with dacarbazine, compared with only 3.9 percent of patients in the control arm, the companies said.