NeuroproteXeon additional Phase 2 data published in JACC
Closely-held NeuroproteXeon announced the publication of a second finding from a randomized, controlled Phase 2 trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest (OHCA) patients.
The study, which appeared in the latest issue of the Journal of the American College of Cardiology, found that "among comatose survivors of OHCA, in comparison with hypothermia alone, inhaled xenon along with hypothermia suggests less severe myocardial injury as demonstrated by the significantly reduced level of troponin-T." Troponin is a blood-based marker of heart muscle injury.
Earlier published results in the Journal of the American Medical Association in 2016 from the same Phase 2 trial showed significantly less white matter brain damage in patients receiving xenon, oxygen and hypothermia versus hypothermia alone.
NeuroproteXeon is preparing to start a 30-center, Phase 3 pivotal trial in the second quarter of 2018. The company has a Special Protocol Assessment with the FDA and a Scientific Advisory Working Party Agreement with the European Medicines Agency (EMA).
The company also has received orphan designation from the FDA and EMA for this application, with related market exclusivity.