Maxim Maxamine
Executive Summary
Phase III study of histamine dihydrochloride in combination with interleukin-2 for the treatment of malignant melanoma presented June 2 at a melanoma meeting in Pittsburgh. Maxamine significantly improved survival compared to IL-2 monotherapy in a prespecified subset of patients with liver metastases. For the 129 patients with liver metastases, median survival was 287 days in the Maxamine group, compared to 154 days for the control group. In the total group of 305 patients, median survival was 272 days, compared to 245 days for the control group, not a statistically significant difference. Patients who completed two courses of therapy did have a statistically significant difference in survival from the control group, however, as did patients who were at treatment centers experienced with the regimen. The company plans to file an NDA mid-summer (1"The Pink Sheet" Oct. 18, p. 16)