Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) moved sharply ahead late Tuesday, amid word the company received final protocol guidance from the U.S. Food and Drug Administration (FDA) for a phase 3 clinical trial with trans sodium crocetinate (TSC) in patients newly diagnosed with inoperable glioblastoma multiforme (GBM), a type of brain cancer.
A news released early Tuesday said the trial will compare survival at two years of patients receiving the company’s lead compound TSC with chemotherapy and radiation (standard of care), with patients receiving the standard of care alone. Diffusion intends to begin the trial under the protocol agreed upon by the FDA by the end of 2017.
CEO David Kalergis said, “Following a series of interactions with the FDA, we are gratified to have an agreed-upon protocol and to be preparing to start our TSC Phase 3 trial in patients newly diagnosed with inoperable GBM.”
Diffusion Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy.
Diffusion is developing its lead product candidate, trans sodium crocetinate (TSC), for use in the many cancers where tumor hypoxia (oxygen deprivation) is known to diminish the effectiveness of SOC treatments.
TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent addition of any serious side effects.
The company’s stock hurtled higher 29 cents, or 18%, to $1.90.
