FDA Approves NuvOx IND Brain Tumor Trial

The US Food and Drug Administration (FDA) has approved NuvOx Pharma’s application to proceed with Phase 2 clinical trials for an Investigational New Drug (IND) to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor glioblastoma multiforme (GBM).

The injectable drug is designed to reduce tumor hypoxia in order to make tumors more sensitive to radiation therapy and chemotherapy. It works by traveling through the bloodstream, first picking up oxygen in the lungs before proceeding to hypoxic tissue where it passively delivers the oxygen.

Hypoxic tumors are resistant to radiation therapy and certain kinds of chemotherapy. The trial’s principal investigator, Baldassarre Stea, said tumor hypoxia is known to be a problem in many tumor types, including GBM. By increasing tumor oxygen levels, he said the NuvOx drug is designed to improve the effectiveness of these therapies to kill cancer cells more effectively and increase patient survival. “Clinical trials are needed to see if NVX-108 can become approved by regulators,” Stea noted.

The US clinical stage biopharmaceutical company based in Tucson, Arizona, is developing a platform of oxygen therapeutics to treat life-threatening diseases where hypoxia plays a role. It said pre-clinical data has shown efficacy in several indications including hypoxic solid tumors, stroke, sickle cell crisis, hemorrhagic shock, traumatic brain injury and myocardial infarction. Compared to prior fluorocarbons, NuvOx’s DDFPe is claimed to be active at less than 1/200th the dose.

In addition to the just approved oncology trial, the Arizona biotech firm also has a product in a Phase Ib/II clinical trial to treat acute ischemic stroke and an IND approval for a Phase Ib clinical trial for sickle cell crisis.