NuvOX Pharma, a Tucson Arizona-based biotechnology company, received the green light in the form of a “No Objection Letter” form Health Canada to initiate a Phase 2a clinical trial investigating NanO2 in COVID-19 patients with acute hypoxic respiratory failure (AHRF). As it turns out, some patients with AHRF progress to a far more severe and dangerous acute respiratory distress syndrome (ARDS), which is associated with lung inflammation associated with lower blood oxygenation in COVID-19 patients: leading to a greater probability of death. As the biotech firm has preclinical animal research data revealing NanO2 can restore oxygen levels in low oxygen conditions associated with ARDS or acute lung injury. Additionally, human clinical data points to efficacy when NanO2 was tested in human trials (brain cancer and stroke). Hence, the forthcoming clinical trial led by McGill University for the Canadian effort.
What investigational site(s) will lead this study?
McGill University, Montreal, Canada and Banner University Medical Center in Tucson, AZ.
Who is the Principal Investigator?
Diego Martin, MD, PhD, Chairman of Radiology, McGill University in Canada and in the United States Jarrod Mosier, MD, Associate Professor with Tenure Emergency & Internal Medicine and Associate Program Director of the Critical Care Fellowship at Banner University Medical Center, Tucson, AZ
What is the hypothesis behind the trial?
McGill University’s Dr. Martin has collaborated with Dr. Unger of NuvOx Pharma in pursuit of better understanding models of myocardial infarction producing evidence that NanO2 can act as a cardioprotectant. There is growing evidence that those patients that succumb to COVID-19 triggered ARDS suffer multi-organ damage to the heart, brain, kidneys and other organs. A large percentage of patients who are infected with COVID-19 also have underlying cardiac disease or cardiovascular risk factors. As it turns out, the sponsors declare that it appears NanO2 could be reversing ischemia-mediated pathways of inflammation and tissue injury in the lung, heart and other tissues. The sponsor and investigators suggest that hence NanO2 may help mitigate dangerous COVID-19 impacts. Hence, the goal of the trial is to determine if NanO2 improves clinical outcomes in COVID-19 patients with acute hypoxic respiratory failure.
Who is NuvOX Pharma?
Based in Tucson, AZ, NuvOx Pharma is developing a is developing a platform of drugs that, upon intravenous injection, flow through the bloodstream arriving first at the lungs to pick up oxygen and finally to hypoxic tissue where they passively deliver the oxygen. Indications for NuvOx’s drug include Stroke (Phase II ready), Oncology (Phase II ready), and Sickle Cell Crisis (Phase Ib ready). They have raised a total of $17.1 million since their founding in 2008.
Where does the IP originate from?
NuvOx’s discovery of NanO as the world’s most effective oxygen therapeutic derives from Dr. Unger’s pioneering work in microbubbles. Dr. Unger’s first company, ImaRx Pharmaceutical, developed the world’s #1 selling microbubble product, Definity®, as an ultrasound contrast agent.