This randomized, placebo-controlled, double-blind, dose-escalation clinical trial in acute ischemic stroke patients was designed to demonstrate maximum tolerated dose, characterize adverse events (AEs), and explore clinical outcomes when intravenous DDFPe was used as neuroprotection. Intravenous DDFPe appears to be safe at all doses tested. Clinical improvements in NIHSS score and mRS were significant but compromised by small sample size.
Positive results of NuvOx Pharma’s NVX-208 in the treatment of stroke have been published at the International Stroke Conference. A randomized 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. See the results...
The results of a randomized, blinded, placebo-controlled clinical trial testing intravenous DDFPe in patiets with acute ischemic stroke are presented. 6 patients received placebo, six patients received 0.05 ml/kg of DDFPe every 90 minutes for three doses, six patients received 0.10 ml/kg of DDFPe every 90 minutes for three doses, and six patients received 0.17 ml/kg of DDFPe every 90 minutes for three doses. IV DDFPe appeared safe at all tested doses. No MTD was defined. Exploratory Aims suggest that early DDFPe treatment improves NIHSS quickly and high dose DDFPe patients suggested improved outcomes. Larger trials are warranted.
In addition to the company's innovation in oxygen therapeutics, NuvOx also has an active pipeline of diagnostics in development. The National Cancer Institute has awarded a $2M Small Business and Innovation Research grant to fund the development of a new strategy to detect pancreatic cancer. For more information, read here.
The FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial in 60 stroke patients to proceed to test NuvOx’s investigational drug product, dodecafluoropentane emulsion (DDFPe). Read more...
NuvOx Pharma has received a Phase I SBIR grant for $150,000 from the National Institutes of Health, specifically the National Institute of Neurological Diseases and Stroke (NINDS), for development of a novel syringe sonication device that may allow quick preparation of an investigational drug for oxygen delivery. For more information, read here.
Dodecafluoropentane emulsion (DDFPe) is a novel nanotechnology for oxygen delivery with therapeutic potential for hemorrhagic shock and/or traumatic brain injury (TBI). DDFPe demonstrates efficacy at smaller doses than previously tested perfluorocarbon oxygen therapeutics. This smaller dose potentially eliminates toxicities exhibited by previous oxygen therapeutics, while anti-inflammatory properties of DDFPe may alleviate damage from ischemia reperfusion injury. This mini-review summarizes our progress in developing a battle-field ready product to prevent combat death due to hemorrhagic shock and/or TBI.