Brain Cancer Injectable Drug Trial Gets Go-Ahead from FDA

FDA allows NuvOx Pharma to run a phase II clinical trial in brain cancer.

Nuvox Pharma announces that the FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme (GBM).

NVX-108 is an injectable drug that travels through the bloodstream arriving first at the lungs to pick up oxygen and finally to hypoxic tissue where it passively delivers the oxygen. It is designed to reduce tumor hypoxia in order to make tumors more sensitive to radiation therapy and chemotherapy.

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

NuvOx Pharma is a clinical stage pharmaceutical company that is developing a platform of oxygen therapeutics. In addition to the above oncology trial, the company also has a product in a Phase Ib/II clinical trial in acute ischemic stroke, and has an IND allowed for a Phase Ib clinical trial for sickle cell crisis.

(Source: Business Wire)