Maxim's Maxamine Phase III data

MAXM's first U.S. Phase III study of its Maxamine histamine immune stimulant in combination with IL-2 compared to IL-2 alone hit one of two primary end points, that of a significant increase in survival duration. In the overall population of 305 patients with stage IV melanoma, the median survival of the Maxamine group was 272 days compared to 245 days for IL-2 patients, a difference that was not statistically significant. The primary end point was met in a prospectively defined group of 129 patients who entered the study with liver metastases, in which median survival for the Maxamine group was 283 days compared to 154 days for IL-2 alone (p=0.004).

MAXM Chairman and CEO Larry Stambaugh told BioCentury that "we predetermined with the FDA that if we hit at least one of the primary end points, the product could be filed for approval." ...