Tucson-based NuvOx Pharma says it has been allowed an investigational drug application by the U.S Food and Drug Administration to test a drug candidate for stroke.
NuvOx, which is headed by University of Arizona radiology professor Dr. Evan Unger, says the FDA action allows its oxygen-carrying drug, NVX-208 or dodecafluoropentane emulsion, to be tested in a Phase Ib trial in stroke patients.
The trial will be performed at the University of Arkansas Medical System in Little Rock, under the direction of Dr. William Culp, the Jonathan Fitch distinguished chair in stroke.
Culp said in a news release that pre-clinical studies found that the drug decreases the brain damage from stroke by more than 80 percent and extends the period of efficacy of the only approved drug to treat stroke.
The planned trial will determine the recommended dose of NVX-208 in stroke patients so that it can be tested in a randomized study of patients, Culp said.
NuvOx already is conducting a Phase Ib/II clinical trial of a related drug, NVX-108, in patients with brain cancer. That drug is designed to reverse a low-oxygen state of tumors to make them more vulnerable to radiation treatment.
The company also has an active investigational drug application for sickle cell disease for another version, NVX-508.
Unger is a UA professor of radiology and biomedical engineering and a member of the UA Cancer Center.
He is inventor on more than 100 issued patents and has led the development of three medical imaging compounds approved by the FDA.
