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Diffusion Pharmaceuticals Inc., a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, completed 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.”
Diffusion is now interacting with the FDA on details regarding the design and execution of the planned Phase 3 study, with initiation planned for later this year. The study will focus on newly diagnosed GBM patients who have been judged by their medical team to be inoperable, usually because of the size or location of the tumor. Because of their poor prognosis, these patients are often excluded from participation in other GBM clinical trials. In the Company’s Phase 2 GBM study, the TSC-treated group showed a nearly four-fold increase in survival at two years, when compared to the historical controls.
Original Article: Diffusion Achieves Milestone For Planned Phase 3 Clinical TrialNEXT ARTICLE
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