A Tucson-based drug development company has won approval for a clinical trial to test one of its drug candidates to treat complications from sickle cell disease.
NuvOx Pharma will conduct a trial of its investigational new drug, NVX-508 for vaso-occlusive crisis and acute chest syndrome in sickle cell disease, after receiving approval from the U.S. Food and Drug Adminstration.
NuvOx also has received an βorphan drugβ designation from the FDA for its NVX-508 for the sickle cell complications. Orphan-drug status, which applies to drugs to treat relatively rare diseases, provides sponsors with special development and commercial incentives and a seven-year period of market exclusivity after marketing approval.
Vaso-occlusive crisis, one of the most severe complications of sickle cell disease, typically involves excruciating, debilitating, episodic pain and can contribute to infection, stroke, multi-system organ damage, and shortened life expectancy, NuvOx said. A related condition, acute chest syndrome, is one of the leading causes of death in sickle cell patients.
NuvOxβs drug candidate treats hypoxia, a low oxygen state in tissues, which contributes to the underlying processes in both vaso-occlusive crisis and acute chest syndrome, the company said in a new release.
Dr. Evan Unger, a UA radiologist and president and CEO of NuvOx Pharma, said the FDAβs acceptance of NVX-508 as an investigational new drug will pave the way for a clinical trial starting this year.
The trial will be conducted in collaboration with Dr. Solomon Ofori-Acquah, associate professor of medicine and human genetics and director of the Center for Translational and International Hematology at the University of Pittsburgh.
The clinical trial will be the second for NuvOx Pharma, which is also conducting a Phase 1b clinical trial for another drug, NVX-108, for the brain cancer glioblastoma multiforme.
