GVAX vaccine using autologous: SOMA plans to start in May a Phase III trial

About 350 patients will be enrolled at 50 sites. Half of the patients will receive an initial high dose of GVAX and three subsequent vaccinations at two week intervals, followed by periodic lower dose booster shots. The control group will be monitored but will not receive therapy.

The primary end point is disease-free survival at two years. An interim analysis of the five-year trial will be conducted after 2.5 years. ...