Diffusion prepares for Phase 3 trial in GBM
CHARLOTTESVILLE, Va.—Biotechnology company Diffusion Pharmaceuticals Inc. recently announced the selection of an unnamed “premier clinical research organization” to conduct a Phase 3 clinical trial of trans sodium crocetinate (TSC), Diffusion’s lead molecule, in patients with inoperable glioblastoma multiforme (GBM). The company also inked agreements with “top-tier partners” who will manage the MRI imaging, clinical data management, drug supply and other trial functions, with trial initiation expected by the end of the year. TSC targets tumors’ hypoxic micro-environment, re-oxygenating the tissue and making cancer cells more vulnerable to treatment. A Phase 2 trial in GBM saw nearly a four-fold increase in survival at two years in the TSC-treated inoperable group compared to control. TSC also demonstrated a favorable safety profile combined with standard of care.