NeuroproteXeon has announced the publication of a second finding from a randomised, controlled phase II trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest (OHCA) patients.
The study, which was published of the Journal of the American College of Cardiology found, “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 (p= 0.01)”.
According to a press release, earlier published results from the same phase II trial, showed significantly less white matter brain damage in patients receiving xenon, oxygen and hypothermia versus hypothermia alone (p=0.006)—these results were published in the Journal of the American Medical Association last year.
The press release reports that NeuroproteXeon is preparing to start its 30-centre, phase III trial in the second quarter of 2018. The company has an agreed special protocol assessment with the US FDA and a scientific advisory working party agreement with the European Medicines Agency (EMA). Both the FDA and EMA have provided the company with orphan designation on this application with related market exclusivity (seven and 12 years, respectively).