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- In stroke, animal studies show that DDFPe can reduce neurological damage by 85%. A randomized, placebo controlled Phase Ib/II trial tested acute ischemic stroke patients given placebo or low, medium, or high doses of NVX-208. The primary endpoint was safety, which was demonstrated at all three dose levels. A secondary endpoint was the modified Rankin Scale (mRS), a measure of how independently patients can live in the weeks and months after the stroke. The high dose group suggested improvement in the mRS at 30 days and 90 days.
- In oncology, DDFPe is designed to reduce tumor hypoxia in order to make tumors more sensitive to radiation, chemotherapy, and/or immunotherapy. It has completed enrollment in a Phase Ib/II clinical trial in glioblastoma multiforme patients receiving radiation therapy and chemotherapy. The trial showed statistically significant evidence of tumor re-oxygenation (p=0.015) with no significant change in the oxygenation of the normally oxygenated brain tissue (p=0.65). Early results show evidence of increased overall survival. The FDA has allowed an Investigational New Drug application for a Phase II clinical trial.
- In sickle cell crisis, a pre-clinical study of acute chest syndrome in mice saw 0% survival in controls and 100% survival in treated animals.
- In traumatic brain injury (TBI), animal studies by the US Navy showed an increase in brain tissue oxygen tension with DDFPe administration following TBI in rats, and a reduction in ischemic neurons and spongiosis after TBI in pigs.
- In myocardial infarction, studies in mice show that DDFPe can reduce the damage to cardiac tissue from myocardial infarction by 72% when DDFPe is given after myocardial infarction is induced.
- In hemorrhagic shock, several studies by the US Army showed 0% survival in controls and 100% survival in treated animals. NuvOx has partnered with Jiangsu Nhwa Pharmaceutical Co., Ltd., to develop the product in China – NuvOx retains rights in the rest of the world for treatment of hemorrhagic shock.