NuvOx Pharma and the University of Arkansas Initiate Phase Ib/II Clinical Trial in Stroke

UAMS NuvOx Pharma announces that the first patients have been dosed in a Phase Ib/II clinical trial for NVX-208, an oxygen therapeutic being developed for acute ischemic stroke. The trial is being performed at the University of Arkansas for Medical Sciences in Little Rock, Arkansas under the direction of Dr. William Culp, the Jonathan Fitch Distinguished Chair in Stroke. Dr. Culp said, “We have studied NVX-208 in a number of animal stroke models and found that administration of NVX-208 decreased the brain damage from stroke by over 80%. The only approved drug to treat stroke is the thrombolytic drug t-PA, which has a risk of bleeding and is approved for use only up to 3 hours following stroke. Administration of NVX-208 prior to t-PA extended the time window of efficacy to at least 9-hours in rabbits.”

This Phase Ib/II trial is a randomized, placebo controlled, blinded, dose escalation trial that will enroll up to 24 patients. The primary endpoint is to find the maximum tolerated dose for NVX-208. Although the drug will not be used to extend the time-window for the clot-busting drug t-PA in this trial, it may still have a beneficial effect on outcomes in stroke patients and the researchers will look to see if there is a trend in NIH Stroke Scale, a measurement of stroke severity in the patients. NuvOx Pharma CEO, Evan Unger MD, says, “NVX-208 has great potential to improve both treatment and outcome of stroke patients. Stroke is the fifth leading cause of death in the US and a leading cause of serious long term disability. It costs the US an estimated $33 Billion per year. Improved treatment could not only decrease mortality and morbidity but also decrease health care costs. Subsequent clinical trials will be needed to see if NVX-208 can become approved by regulators.”

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