Aptiv Solutions will manage the Galena Phase 3 trial, PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment).
The FDA approved trial involves more than 700 patients across the globe and is likely to start in the first half of 2012.
NeuVax containing E75 peptide is derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF).
Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2.
NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months.