Diffusion finds trans sodium crocetinate well-tolerated in Phase I

Diffusion said that the drug uses a novel mechanism of action allowing more oxygen to reach oxygen-deprived tissues in the body. The company’s next clinical study will examine the safety and effects of trans sodium crocetinate (TSC) on oxygenation levels of cancerous tumor tissue in primary brain tumor patients who have glioblastoma multiforme (GBM) and will be undergoing a surgical procedure for tumor biopsy and/or tumor resection.

David Kalergis, CEO said: “Successful completion of this study is a key milestone in the clinical development of TSC and significantly advances our lead product candidate toward commercialization. The results of our Phase I trial and recent preclinical studies, coupled with completion of the private placement, will enable us to move quickly into Phase II proof-of-concept studies with TSC in two diverse patient populations, peripheral vascular disease and cancerous brain tumors, both of which exhibit oxygen deprivation at the cellular level.”

Further trials in GBM patients will examine the safety and effects of TSC, including impact on patient survival, when combined with radiation therapy. These clinical trials will be sponsored by Diffusion Pharmaceuticals, and conducted in collaboration with The Johns Hopkins University School of Medicine and the New Approaches to Brain Tumor Therapy Central Nervous System Consortium.