Tucson, AZ, August 4th, 2023 - NuvOx Pharma (NuvOx), a clinical stage biotechnology company developing a first-in-class therapeutic to treat life-threatening diseases where hypoxia plays a role, announced the US Department of Health & Human Services, Biomedical Advanced Research and Development Authority (BARDA) has entered a partnership with NuvOx to support a Phase Ib ARDS/COVID-19 trial in Canada: novel oxygen therapeutic NanO2 for coviD19(EXTEND). This is a dose escalation trial, aiming to inform the safety profile of NuvOx’s product - NanO2 TM, for patients at risk for mechanical ventilation.
Dr. Evan Unger, CEO and co-founder of NuvOx said, “Severe COVID-19 and ARDS patients are at risk for mechanical ventilation, which is known to be of high rate of injury and mortality. NanO2 is designed to rapidly reverse hypoxia, restore PaO2 in patients’ lungs and revert hypercapnia so that patients can fight respiratory disease without exposing themselves to such injuries and possible mortality. It is an extremely impactful indication for our platform technology.”
Dr. Jarrod Mosier, Professor of Emergency Medicine and Medicine at the University of Arizona College of Medicine-Tucson and DSMB Chair for this trial, said: “Intravenous oxygen therapeutics present an appealing option for improving arterial oxygenation in patients with acute hypoxemic respiratory failure at multiple points along the spectrum of conventional management. In our recently published article in Journal of Intensive Care Medicine Experimental - The impact of intravenous dodecafluoropentane on a murine model of acute lung injury, the animal model indicated that NanO2 is an appealing candidate for improving arterial oxygenation in the presence of ventilation: perfusion mismatch and intrapulmonary shunt. I am excited to see the start of a human trial, and am honored to serve on its DSMB.”
Dr. Jenny Johnson, Chief Scientific Officer and co-founder of NuvOx said: “We have terrific animal data from ARDS models and are excited to start trials in humans. This trial has a well-designed dose escalation theme, and we look forward to working with Canadian clinical and regulatory experts. As we have an on-going oncology trial in United States, we will be able to leverage what we learned and other logistic infrastructure to expedite the trial.”
“This trial is an integral part of our pipeline and strategic development map,” added Rong Wang, Chief Operating and Financial Officer, “We have allowance from Health Canada to conduct up to Phase II trials, but lacked funding. Therefore, we are extremely grateful for BARDA’s support. We look forward to completion of this trial, and the planned subsequent development of dose expansion.”
About the EXTEND Trial
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00034. About NuvOx NuvOx is a privately held, clinical Phase IIb stage company, developing a novel oxygen therapeutic where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of COVID-19 patients with acute respiratory distress syndrome (ARDS). The Company’s lead drug - NanO2 TM represents a disruptive platform technology addressing multiple highly unmet needs, with positive clinical efficacy demonstrated in two completed Phase Ib/IIa studies: glioblastoma multiforme as a radiosensitizer and stroke as a neuroprotectant. It was shown to be the most effective oxygen therapeutic from the literature survey from 74 clinical-stage compounds. It has safety and efficacy data in 7+ indications in various clinical stages, including Orphan Drug Designation for both glioblastoma and sickle cell. The product was derived from Dr. Evan Unger’s pioneering work in microbubbles, which was commercialized as the #1 selling contrast agent. As such, it has safety data in 2,000+ subjects. The product is designed to be synergistic, rather than competitive with standard of care.
NuvOx Pharma Dr. Evan Unger, CEO Rong Wang, COO/CFO
Rong Wang T: 520.624.6688
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