FDA Allows a Phase II Clinical Trial in Stroke for NuvOx Pharma’s DDFPe

 NuvOx Pharma, a clinical stage biotechnology company, announces that the FDA has allowed a Phase II clinical trial in 60 stroke patients to proceed to test NuvOx’s investigational drug product, dodecafluoropentane emulsion (DDFPe). Upon intravenous injection, DDFPe travels through the bloodstream, arriving first at the lungs to pick up oxygen and finally to hypoxic tissue where it delivers the oxygen. DDFPe is being developed to determine if it can deliver oxygen to parts of the brain affected by stroke.

Approximately 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. It is hoped that the drug will protect the tissues in the brain by maintaining oxygen levels, and the study will monitor the oxygenation of the brain and severity of stroke in each patient using magnetic resonance imaging (MRI).

The trial will be run in cooperation with the Banner University Medical Center in Tucson, Ariz. 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."

NuvOx is a privately held company with clinical programs in stroke, brain cancer and sickle cell disease

Disclaimer: Certain statements in this release may constitute "forward-looking statements." Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.

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