TUCSON, Ariz.--(BUSINESS WIRE)--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.

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. We

undertake no obligation to publicly update or revise any forward-looking

statements, as a result of future events, new information, or otherwise.

Contacts

NuvOx Pharma

John McGonigle