ImmunoCellular continues to guide that the Data Monitoring Committee for the ICT-107 trial in glioblastoma multiforme will conduct an interim safety and futility analysis during the second quarter. The Company believes that the most positive outcome would be a recommendation to continue the trial. IMUC continues to expect that it will have top line results at the end of 2013.
The phase II trial is based on 124 patients with an endpoint of median overall survival. It is randomized roughly 2:1 so that about 83 patients will receive ICT-107 plus standard of care and 41 will receive standard of care. The powering assumes an improvement for the ICT-107 regimen of 8.0 months over 18.8 months median overall survival assumed for standard of care.