Diffusion completes animal toxicology studies

Diffusion Pharmaceuticals has completed the dosing of two animal toxicology studies that are required by the U.S. Food and Drug Administration (FDA) for approval of Diffusion’s lead molecule trans sodium crocetinate (TSC) Phase 3 trial.

The trial will test TSC in patients who have been recently diagnosed with Glioblastoma (GBM).

“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,” Diffusion Chairman and CEO David G. Kalergis said.

At the end of its meeting with the FDA regarding the Phase 2 trial, Diffusion reported that the Phase 3 trial will see a doubling in TSC dosing exposures per patient. The Phase 3 trial design agreement states that the FDA has requested the augmentation of Diffusion’s existing TSC toxicology studies with the addition of TSC toxicology data in rats and dogs for the span of three months.