Multidose Oxygen Therapeutic For Radiation Sensitization Treatment Of Glioblastoma Multiforme.

TPS2112 Background: NuvOx is running a Phase 1b/2 evaluation of dodecafluoropentane emulsion (2% DDFPe) as a radiation sensitizer administered intravenously prior to radiation treatment (RT) in Glioblastoma (GBM) patients. Pre-clinically, DDFPe has been shown to increase tumor pO2 concentration of hypoxic solid tumors with an increase in survival. An NDA for DDFPe was previously to the FDA and considered safe and effective as an imaging agent in over 2200 patients. Subsequently DDFP was found to have 200 times the oxygen carrying capacity relative to hemoglobin, which led to the hypothesis that relatively low doses of DDFPe would be safe and effective at reversing hypoxic conditions and improve the effectiveness of the standard fractionated RT in post-resected GBM patients. Methods: This study is intended to determine the safe and effective therapeutic dose for fractionated radiation treatment of GBM. The dosing schedule begins at 0.05cc/kg and escalates to 0.35 cc/kg. The study is in two parts; the first...