Diffusion Pharmaceuticals Receives Accelerated FDA Response to Proposed TSC COVID-19 Clinical Trial Program. First U.S. study to feature double-blinded, controlled, randomized trial design with safety and oxygenation endpoints. FDA recommends incorporating remdesivir, where available.
Diffusion Pharmaceuticals is a Phase 3 clinical-stage biotech company dedicated to improving the outcome for cancer patients, stroke victims and others afflicted with life-threatening disease where cellular oxygen deprivation (known as ``hypoxia``) is a key factor
Our lead drug, Trans Sodium Crocetinate (“TSC”), targets the oxygen-deprived micro-environment of affected tissue, restoring life-giving oxygen to ischemic cells in stroke making cancer cells more vulnerable to the cancer-killing power of radiation and chemotherapy
Clinical targets include cancer, where a phase 3 trial in inoperable GBM brain cancer is enrolling patients, and acute ischemic stroke where we have received FDA approval for an innovative phase 2 protocol allowing in-ambulance administration of TSC
Diffusion’s pipeline shows a lead drug – TSC – with exciting ability to potentially treat a number of serious, life-threatening conditions. A Phase 3 study in inoperable GBM patients is currently enrolling. The U.S. Food and Drug Administration (FDA) recently approved a new Phase 2 in-ambulance study of TSC to treat stroke. 150 emergency transport groups will work with providers at 23 hospitals to treat patients suffering from either ischemic or hemorrhagic stroke. By increasing the amount of oxygen directed to affected tissue, TSC can potentially reduce cell death and improve patient outcomes.