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. Culp said, “We have studied NVX-208 in a number of pre-clinical stroke models and found that administration of NVX-208 decreases 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 nine hours.”
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 allow many more stroke patients to be treated and to improve their outcomes. Stroke is the fifth leading cause of death in the U.S. and a leading cause of serious long term disability. It costs the U.S. an estimated $33 billion per year. Improved treatment could not only decrease mortality and morbidity but also decrease health care costs.”
NuvOx is a privately held biotechnology company based in Tucson, Arizona. NuvOx conducted a Phase Ib/II clinical trial of NVX-108 in patients with brain cancer and has an active IND for sickle cell disease for NVX-508.
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