FDA clears Phase III trial of POL-103A (Polynoma) Melanoma vaccine

The FDA has granted clearance for Polynoma's Investigational new drug (IND) application for POL-103A, allowing it to proceed with Phase III clinical testing of this Malignant Melanoma vaccine. Using a combination of antigens from three proprietary melanoma cell lines, the POL-103A vaccine is intended to stimulate the body's immune system to fight the cancer. Preparation for the Phase III clinical trial is already underway, and it is expected that enrollment of 1059 patients will be conducted in 14 countries. The first patient is expected to be dosed in the 2nd quarter of 2012.