NuvOx Pharma concedes FDA’s approval to Phase II Clinical Trial

FDA permits a Phase II Clinical Trial in 60 stroke patients, NuvOx Pharma announced FDA approval to proceed to test its investigational drug product, dodecafluoropentane emulsion (DDFPe).

Estimates suggest 795,000 people in the U.S. have strokes every year, leading to 140,000 deaths. Stroke is a leading cause of serious long-term disability and is estimated to cost the U.S. $34 billion per year. There are two types of stroke, ischemic and hemorrhagic, and the upcoming Phase II Biomarker Imaging study will enroll both types of patients.

Dr. Chelsea Kidwell, MD, Professor and Vice Chair of Research in Neurology, says, “Hypoxia, or lack of tissue oxygenation, is a critical mechanism of brain injury in both ischemic and hemorrhagic stroke. DDFPe is designed to deliver oxygen to the hypoxic regions of the brain to prevent cerebral tissue damage. This clinical trial aims to visualize the effects of oxygen delivery using DDFPe in both types of stroke patients.”

Image Source: NuvOx Pharma