NuvOx Pharma, a biotechnology company based in Tucson, has reportedly obtained a ‘No Objection Letter’ from the government department, Health Canada. The letter approves the Phase IIa clinical study of NanO2 among the COVID-19 patients with AHRF (acute hypoxic respiratory failure).
Patients suffering from AHRF can progress to a more severe disease known as ARDS (acute respiratory distress syndrome). ARDS is a major cause of the rising mortality rate among these patients. It is associated with the inflammation of lungs that leads to low blood oxygenation.
According to NuvOx Pharma’s CEO & President, Evan Unger, the data collected from the animal trial revealed that NanO2 help restore the level of oxygen in case of low oxygen due to ARDS or acute lung injury. The company also has tested NanO2 among patients with stroke and brain cancer. The results of this trial showed its safety and efficacy in both indications. Owing to this result, the company has designed the new clinical study to identify the effectiveness in the COVID-19 patients.
Diego Martin, Chairman of the Diagnostic Radiology Department at McGill University, has reportedly stated that the university is excited to partner with NuvOx Pharma on the recent clinical trial. COVID-19 patients, apart from ARDS, suffer multi-organ damage to kidneys, brain, heart, and other organs. Additionally, several patients have underlying cardiovascular risk factors. NanO2 can potentially reverse the ischemia-mediated inflammation pathways and tissue injuries.
As per the statement made by Jarrod Mosier, Associate Professor with Tenure in Internal Medicine & Emergency, and Critical Care Fellowship’s Associate Program Director at Banner – University Medical Center Tucson, a sustained IV infusion of NanO2 will be administered to patients in the latest trial. The 1st phase can be considered a dose-escalation design, after which subjects will be further enrolled at the selected dose for expanding the study. It will examine the safety and efficacy of NanO2 among the coronavirus infected patients with AHRF and low oxygen saturation.