Glioblastoma Program

A successful Phase1/2 trial of TSC in newly diagnosed GBM patients was completed in the first half of 2015. In the secondhalf of 2015, agreement was reached with the FDA on the design of a single Phase 3 study that would support registration of TSC for the initial treatment of newly diagnosed GBM patients, in combination with both radiation and chemotherapy. This trial is expected to begin enrollment in 2016.

TSC to Counter Treatment Resistance in GBM

Number of patients: 400 (200 treated with standard of care; 200 treated with standard of care plus TSC.)

Number of sites: 65 (approx. 35 US and 30 international)

Primary endpoint: Overall survival

Secondary endpoints: Tumor status, Q of L, Performance

Safety endpoints: Standard for oncology studies, monitored by a DSMB