On February 8, 2017 Feb. 08, 2017 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported that the data from the Phase 1/2 clinical trial evaluating the safety and efficacy of trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) has been published in the print edition of the peer-reviewed Journal of Neurosurgery ("JNS") (Volume 126, February 2017) (Press release, Diffusion Pharmaceuticals, FEB 8, 2017, View Source [SID1234517657]). Results from the Phase 1/2 clinical trial in 59 patients showed that 36.3% of the full TSC dose patients were alive at two years, compared to historical two-year survival rates ranging from 27% to 30%. TSC, the Company’s lead product candidate, is designed to target the tumor’s reduced oxygen microenvironment. TSC re-oxygenates cancerous tissue, thus making the cancer cells more susceptible to current radiation therapy and chemotherapy. Schedule your 30 min Free 1stOncology Demo! "The publication of the article in the JNS provides peer-reviewed validation and raises the visibility of Diffusion across key stakeholder audiences," stated David Kalergis, Chairman and Chief Executive Officer. "The very encouraging data from our Phase 1/2 clinical trial supports our strategy to advance into Phase 3 clinical development."
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The article, entitled, "Trans sodium crocetinate with temozolomide and radiation therapy for glioblastoma multiforme," outlines the results of a Phase 1/2 trial designed to evaluate the therapeutic effect of adding TSC to radiation therapy in 59 newly diagnosed GBM patients. In this trial, all patients received radiation with the drug temozolomide beginning either after surgery or biopsy of the tumor. TSC was administered around 45 minutes before each radiation session three days per week during the 6 weeks of radiation therapy. Considerable tumor shrinkage was seen in many patients, with tumors in 11 patients disappearing completely.
JNS is the official peer-reviewed publication of the American Association of Neurological Surgeons. Diffusion’s data was previously published in the online edition of JNS in May 2016 and was originally released in July 2015.
About Treatment-Resistant Cancers and TSC
Oxygen deprivation at the cellular level ("hypoxia") is the result of rapid tumor growth, causing the tumor to outgrow its blood supply. Cancerous tumor cells thrive with hypoxia and the resultant changes in the tumor microenvironment cause "treatment-resistance" to radiation therapy and chemotherapy. Using a novel, proprietary mechanism of action, Diffusion’s lead drug TSC counteracts tumor hypoxia – and therefore treatment-resistance – by safely re-oxygenating tumor tissue, thus enhancing tumor kill and potentially prolonging patients’ life expectancy. Oxygen levels of normal tissue remain unaffected upon administration of TSC, thereby avoiding the introduction of harmful side effects.