On September 19, 2016 Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported the successful completion of dosing of two animal toxicology studies required by the U.S. Food and Drug Administration (FDA) to support Diffusion’s planned Phase 3 clinical trial testing its lead molecule trans sodium crocetinate (TSC) in newly diagnosed Glioblastoma (GBM) patients (Press release, Diffusion Pharmaceuticals, SEP 19, 2016, View Source [SID:SID1234515214]). Schedule your 30 min Free 1stOncology Demo! As outlined at the end of Phase 2 FDA meeting, the number of TSC dosing exposures per patient will double in the planned Phase 3 trial as compared to the Phase 2 trial. As part of the agreement reached on a trial design for the Phase 3 study, the FDA requested that Diffusion augment its existing TSC toxicology studies with additional three month TSC toxicology data in both rats and dogs. The animal dosing for these three month studies has now been successfully completed.
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David G. Kalergis, Diffusion’s Chairman and Chief Executive Officer, said, "The successful completion of dosing for these three month animal toxicology studies is an important milestone in support of Diffusion’s ability to conduct a Phase 3 pivotal trial of TSC in newly diagnosed GBM patients."