Glioblastoma Program

A successful Phase 1/2 trial of TSC in newly diagnosed GBM patients was completed in the first half of 2015. The Company is now completing the design of a single Phase 3 study that could support registration of TSC for the initial treatment of newly diagnosed inoperable GBM patients, in combination with both radiation and chemotherapy.

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Number of patients: 230 (115 treated with standard of care; 115 treated with standard of care plus TSC.)

Number of sites: 100 (approx. 54 US and 46 international)

Primary endpoint: Overall survival

Secondary endpoints: Tumor status, Q of L, Performance

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