Diffusion Pharmaceuticals Achieves Drug Production Milestone For Planned Phase 3 Clinical Trial In Inoperable GBM Brain Cancer
CHARLOTTESVILLE, Va., July 20, 2017 -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, today reported the completion of a major production run of its lead drug candidate trans sodium crocetinate (TSC). This drug supply will be used in its planned Phase 3 trial which will test TSC in the treatment of newly diagnosed inoperable glioblastoma (GBM) brain cancer patients and is of sufficient quantity to support the entire trial. Diffusion plans to initiate this clinical trial by the end of 2017.
“Diffusion has reached an important milestone for initiating the Phase 3 trial with this successful manufacture of Phase 3-ready TSC,” said David Kalergis, Diffusion’s Chairman and CEO. “In its End-of-Phase-2-Meeting response, the FDA required that any TSC used in upcoming Phase 3 studies must be made using commercially-ready processes, both for the active pharmaceutical ingredient (API) and formulated drug product. The necessary advanced production and formulation processes were implemented over the last eighteen months and were cleared with the FDA in June, immediately prior to the successful clinical trial supply production run earlier this month.”
- Published: 20 July 2017
- Written by Editor