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Diffusion Pharmaceuticals Selects Contract Research Organization for Phase 3 Clinical Trial

15:39 EDT 9 Aug 2017 | Virginia Biotechnology

Diffusion Pharmaceuticals, Inc., a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, announced today that it has selected a premier Clinical Research Organization (CRO) to conduct a Phase 3 clinical trial of Diffusion's lead molecule, trans sodium crocetinate (TSC), in inoperable glioblastoma multiforme (GBM) patients. Diffusion also entered into agreements with top tier partners to manage the MRI imaging, clinical data management, drug supply and other functions related to the trial. Diffusion plans to initiate this Phase 3 clinical trial by the end of 2017.

“After reaching the critical milestone of manufacturing drug product for our Phase 3 trial earlier this month, we have now reached another major milestone with the selection of our full clinical trial team, including a leading global CRO and first-in-class providers of imaging and data management services,” said David Kalergis, Diffusion’s Chairman and CEO. “We are pleased to have engaged such skilled and experienced partners for this important endeavor.”

Diffusion is now interacting with the FDA on details regarding the design and execution of the planned Phase 3 study. The study will focus on treating 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. Due to their poor prognosis, these patients are often excluded from participation in other GBM clinical trials. In the Company’s Phase 2 GBM trial, the TSC-treated inoperable group showed a nearly four-fold increase in survival at two years, compared to the control.

Original Article: Diffusion Pharmaceuticals Selects Contract Research Organization for Phase 3 Clinical Trial

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