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NetworkNewsBreaks – Diffusion Pharmaceuticals, Inc. (NASDAQ: DFFN) Shares Surge after Receiving Final FDA Protocol Guidance for TSC Phase 3 Clinical Trial

Company: Diffusion Pharmaceuticals, Inc. (DFFN)
Category: News

Shares of Diffusion Pharmaceuticals, Inc. (NASDAQ: DFFN) are up 35.4% this morning after the company said it has 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. 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. “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 chief executive officer David Kalergis stated in the news release.

To view the full press release, visit: http://nnw.fm/yNnJ1

About Diffusion Pharmaceuticals, Inc.

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, 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. A phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed glioblastoma multiforme, a type of brain cancer. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years.  A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies.  Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers. Additional planned studies include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The company also believes that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine. For more information, visit www.diffusionpharma.com.

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