Tucson, AZ (PRWEB) August 07, 2014
NuvOx Pharma, a privately held biotechnology company based in Tucson, Arizona, focused on developing a nanotechnology platform for reversing conditions with decreased oxygen announced that on July 14th, it began a Phase Ib clinical trial of its new drug NVX-108 in patients with glioblastoma, a deadly form of brain cancer.
Glioblastoma multiforme (GBM), according to the Central Brain Tumor Registry, affects about 10,300 patients per year in the US. Average survival is only about 12-months following standard therapy, which involves surgery followed by radiation and chemotherapy. GBM, like many other forms of cancer, is known to have low oxygen (hypoxia). Hypoxia adversely affects the response of tumors to radiation therapy and NVX-108 has been shown to raise tumor oxygen levels and improve the response to radiation therapy. The clinical trial is being performed at Monash University in Melbourne Australia. GBM patients who have residual tumor after surgery are receiving an IV dose of NVX-108 during each of the 30 fractions of radiation over a 6-week period. Up to about 25 patients will be treated in the trial. The primary end-point of the trial is safety, but the study will also determine the recommended dose for the drug and provide data on the 6-month survival of the patients. After completion of the trial NuvOx plans to file an investigational new drug application with the FDA and perform a Phase IIb trial in the US.
“We are very excited about moving NVX-108 into the first therapeutic trial. The parent compound, dodecafluoropentane, was previously studied as a contrast agent and was shown to be safe. Due to market considerations it was never launched as a contrast agent. We own that regulatory data and the FDA has agreed that we can reference it in support of clinical development to treat cancer,” said Evan Unger, MD, President and CEO of NuvOx.