CHARLOTTESVILLE, Va.--()--Diffusion Pharmaceuticals LLC announced today that it has opened for enrollment a clinical trial testing the company’s lead drug candidate trans sodium crocetinate (TSC) as a first-line treatment for newly diagnosed primary brain cancer, also known as glioblastoma or GBM. 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.
About the TSC Clinical Trial
This Phase I/II clinical trial will enroll up to 68 patients at up to 20 sites over the next year. Clinical endpoints are overall survival at 2 years and progression-free survival at 6 months. It is believed that trial characteristics will encourage patient recruitment – there are only limited exclusion criteria and all participating patients will receive TSC, which has few reported side effects. A description of the trial is listed on www.ClinicalTrials.gov as NCT01465347.
About Diffusion Pharmaceuticals
Diffusion Pharmaceuticals is a clinical-stage company developing novel drugs which target unmet medical needs. Diffusion’s lead program is the use of TSC in the treatment of solid cancerous tumors. Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia. For more information, visit www.diffusionpharma.com. For information on enrollment in the GBM trial at the University of Virginia Health Sciences Center, Emily Couric Clinical Cancer Center, contact Gretchen Watkins at 434-243-7231 or gmw7h@virginia.edu.