In a stroke clinical trial with NanO2TM, there were no drug related SAEs and no MTD was defined. The high dose cohort (0.17 mL/kg) had a significant improvement in the functional end-point of the modified Rankin scale (mRS) at 90 days (Figure 4). Patients who received NanO2 within 5 hours following stroke had significant improvement in NIH Stroke Score (NIHSS). Brain imaging with BOLD MRI and 18F-MISO (not shown here) havebeen successful in showing the increase in blood oxygenation.
NanO2TM has potential to both save lives and fundamentally improve functional outcomes in stroke patients. Most recently, the National Institute for Health and Care Research (NIHR) in the United Kingdom has allotted funding for a clinical trial using NanO2TM in treating LVO AIS in 150 patients. NuvOx plans to initiate this trial in early 2024. The Stroke Pre-clinical Assessment Network (SPAN) has funded a foundational rodent study to screen acute stroke treatments for readiness to move into clinical trials in the US. NanO2TM has the potential for administration as a standard of care neuroprotectant. Because low doses of the drug are active and safe, it could be deployed early in the care of stroke patients, e.g. in the emergency room or ambulance, to maximize its neuro-protection potential.