The Phase IIb trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study has been enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites. An interim analysis is expected when 32 events have been observed. As the final analysis will be event-driven, increasing the number of patients treated, the Company believes it may shorten the trial by a few months compared to treating only 102 patients. This should also provide more information for robust sub-group analysis of the trial results, as differences in age, degree of resection, and other factors can impact overall survival.
In the Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care treatment of surgery, radiation and chemotherapy demonstrated twoyear overall survival of 80 percent and a three-year overall survival of 55 percent. These figures compare favorably to the current 26 percent two-year overall survival and 16 percent three-year overall survival based on the historical standard of care treatment alone. Updated data from the 16 patients in the Phase I trial shows that patients treated with ICT-107 reported overall survival (OS) of 50% after four years and 38% of the trial patients are progression free (PFS) for 48- 66 months. This compares very favorably to historic mean OS of 12.1% after four years and 5.6 % PFS after 48 months with standard of care alone.