Currently there is no cure for GBM and patients have an average life expectancy of 18 months after diagnosis.
The trial's lead site is the University of Virginia, under Principal Investigator Dr. James Larner, Chairman and Professor of Radiation Oncology. Up to 19 additional institutions in the United States will participate in the trial.
"TSC has demonstrated safety in early human testing as well as significant efficacy in animal studies of brain cancer led by Dr. Jason Sheehan, Professor of Neurosurgery at the UVA," said Dr. Larner. "This trial will test TSC's safety and effectiveness when combined with standard of care treatment, offering a novel and promising clinical trial option for newly diagnosed GBM patients."
The standard treatment for GBM includes surgical removal of the tumor bulk, followed by radiation and chemotherapy. Factors within the tumor micro-environment are thought to account for tumor recurrence, often within months. TSC, which received FDA Orphan Drug designation in July, 2011, enhances oxygen diffusion into this micro-environment, potentially making treatment-resistant tumor cells up to three times more responsive to standard treatments.