NuvOx Pharma Receives FDA Allowance to Proceed with Phase II Clinical Trial of NanO2TM in Ischemic Stroke

Tucson, AZ, July 29, 2021 --(PR.com)-- NuvOx Pharma, a Tucson-based biopharmaceutical company, has received notice from the FDA that they may proceed with a Phase II clinical trial of their drug, NanO2TM, in ischemic stroke.

Stroke affects nearly 800,000 patients each year in the US. It is the fourth leading cause of death in this country, the #1 cause of long-term disability, and the #1 cause of expense for long-term medical care. Evan Unger, MD, CEO of NuvOx said, “Our drug NanO2 safely delivers oxygen to tissues with oxygen deficit. In ischemic stroke, blockage of an artery stops or reduces blood flow leading to a lack of oxygen supply in the brain. The brain tissue gradually dies unless blood flow can be restored. NanO2 provides the needed oxygen to keep the brain tissue alive until blood flow can be restored.”

William Culp, MD, former Fitch Distinguished Professor for Stroke and now Professor Emeritus at the University of Arkansas for Medical Sciences said, “We performed a randomized, prospective, double blinded, placebo-controlled Phase Ib/II clinical trial of NanO2 at the University of Arkansas in patients with acute ischemic stroke. The drug was safe and showed evidence of efficacy with a significant improvement in functional outcome in the patients receiving the highest dose. I am excited about the potential of NanO2.”

Large vessel occlusion (LVO) stroke is the most severe kind of ischemic stroke causing about 90% of mortality and much of the long-term morbidity. Recently, mechanical thrombectomy (MT) has emerged as the standard of care in treatment of LVO stroke. MT is only available at specialized centers. NuvOx’s Phase II trial is called the PROVEN Trial (Phase II Trial to Restore Oxygen in Large Vessel Occlusion Stroke en Route to Mechanical Thrombectomy using NanO2). In this trial, eligible LVO stroke patients at peripheral hospitals will receive NanO2 before transfer to specialized centers for MT with the goal of maintaining viability of the brain tissue until reperfusion can be obtained by MT. Successful development of NanO2 as a bridge to reperfusion could enable more patients to be treated with mechanical thrombectomy. This could save lives and greatly improve outcomes in the most severe kind of ischemic stroke.

NuvOx Pharma is a privately held clinical stage pharmaceutical company based in Tucson, Arizona. For further information, visit www.nuvoxpharma.com or contact Evan Unger, MD at eunger@nuvoxpharma.com.

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