NuvOx Pharma has announced 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, USA, under the direction of William Culp, the Jonathan Fitch distinguished chair in Stroke. Culp says, “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 three hours following stroke. Administration of NVX-208 prior to t-PA extended the time window of efficacy to at least nine hours in rabbits.”
This Phase Ib/II trial is a randomised, placebo-controlled, blinded, dose escalation trial that will enrol 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, according to a press release, and the researchers will look to see if there is a trend in National Institutes of Health Stroke Scale.