Partnering with University of Virginia Health and iTHRIV

CHARLOTTESVILLE, Va., April 01, 2020 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (DFFN) (“Diffusion” or “the Company”), 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.

“We are in desperate need of novel therapies to help combat the morbidity and mortality associated with COVID-19 infection,” said Dr. Southerland. “Given our experience partnering with Diffusion Pharmaceuticals to study TSC in clinical trials for other conditions, we believe there is strong biological plausibility that the drug could help COVID-19 patients suffering from ARDS. Our robust infrastructure of research and clinical expertise at UVA positions us well to help bring TSC to COVID-19 trials as soon as possible to determine if it can help patients.”

“TSC’s oxygen-enhancing mechanism may help address the often-fatal multiple organ failure from ARDS in COVID-19 patients,” said Diffusion’s CEO, David Kalergis, JD/MBA. “In addition to UVA/iTHRIV, the Company has begun coordination with researchers from other institutions who have asked to participate in this new program. We have also begun discussions with the FDA. We will issue public updates as warranted by this fast-moving situation.”

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body’s ability to deliver oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions. Diffusion’s lead drug trans sodium crocetinate (TSC) was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat multiple organ failure and its resulting mortality caused by the systemic hypoxemia from blood loss on the battlefield. Evolutions in research have led to Diffusion’s focus today: Fueling Life by taking on some of medicine’s most intractable and difficult-to-treat diseases, including multiple organ failure, stroke and glioblastoma multiforme (GBM) brain cancer. In each of these diseases, hypoxia – oxygen deprivation of essential tissue in the body – has proved to be a significant obstacle for medical providers and is the target for TSC’s novel mechanism.

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