Brain Cancer

Diffusion Pharma begins phase III clinical trial with TSC in GBM

Diffusion Pharmaceuticals announces that a phase III clinical trial of small molecule trans sodium crocetinate (TSC) in patients with newly-diagnosed inoperable glioblastoma multiforme (GBM) cancer, is now open for enrollment. The trial, which has been named INTACT (INvestigating TSC Against Cancerous Tumors), follows a previous phase II GBM study in which the inoperable patient subgroup showed a nearly 4-fold increase in survival compared with historical controls when TSC was added to their treatment regimen (40% alive at 2 years vs 10.4%). TSC’s innovative mechanism of action affects the tumor microenvironment, making treatment-resistant cancer cells more susceptible to the tumor-killing power of conventional radiation therapy (RT) and chemotherapy (temozolomide) by re-oxygenation of the hypoxic portion of the tumor. The trial will enroll 264 patients who will be randomized in a 1:1 ratio into treatment and control groups. The treatment group will receive standard of care (SOC) temozolomide and RT plus an intravenous bolus of TSC administered shortly before their SOC treatments and the control group will receive SOC alone. The study will compare overall survival at 2 years between patients in the 2 groups. Up to 100 clinical sites in the US and Europe are expected to participate. Enrollment will be completed by early 2019, with interim safety and efficacy data possible in 2020 and trial completion in 2021.

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