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Coronavirus / Biotech Stock News Bites: Diffusion Pharmaceuticals (NASDAQ: $DFFN) Evaluating TSC Against Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients


CHARLOTTESVILLE, Va. - April 1, 2020 ( Newswire) Coronavirus / Biotechnology Stock News Bites - Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) , a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body's ability to deliver oxygen to the areas where it is needed most, today announced that it has begun a cooperative research effort with University of Virginia Health (UVA) and the Integrated Translational Research Institute of Virginia (iTHRIV), to evaluate the Company's novel small molecule Trans Sodium Crocetinate (TSC) in patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 infection. iTHRIV is a National Institutes of Health (NIH)-funded Clinical and Translational Awards (CTSA) program. Dr. Andrew Southerland, Associate Professor of Neurology and Public Health Sciences at UVA, will serve as lead Principal Investigator, working with co-investigators in the UVA Division of Pulmonary & Critical Care Medicine.

Patients with COVID-19 infections are at risk for developing ARDS, which can lead to death from systemic hypoxemia (general lack of oxygen to body tissue and vital organs). Diffusion, and researchers affiliated with UVA and iTHRIV, believe the oxygen-enhancing mechanism of action of TSC could benefit COVID-19 patients by mitigating the multiple organ failure that often accompanies systemic hypoxemia, and are, together, exploring avenues to advance TSC's development as quickly as possible for this use.

TSC is currently under clinical development by the Company for other enhanced-oxygen-related uses including the treatment of acute stroke and glioblastoma multiforme (GBM) brain cancer. Preclinical data indicate TSC increases oxygen availability in animal models of acute lung injury, mitigating the negative effects of systemic hypoxemia. Preclinical publications also indicate TSC's ability to mitigate systemic hypoxemia in other animal models, including hemorrhagic shock. Clinical data from 150 patients receiving TSC for other indications demonstrate that the drug has an acceptable safety profile in both healthy and critically ill patients.

The Company and UVA/iTHRIV have together begun discussions with the U.S. Food and Drug Administration (FDA) to assess possible regulatory pathways for the evaluation of TSC in ARDS-related COVID-19 patients.

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