NeuroproteXeon Announces Publication of Xenon Study to Lessen Cardiac Damage Following Out-of-Hospital Cardiac Arrest ("OHCA")
ORCHARD PARK, N.Y., Nov. 28, 2017 /PRNewswire/ -- NeuroproteXeon, Inc. announced the publication of a second finding from a randomized, controlled Phase II trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest patients. The study, which appeared in today's issue of the Journal of the American College of Cardiology (JACC Vol. 70, No. 21, November 28, 2017: 2652-60) 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.
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) Journal of the American Medical Association ("JAMA"), March 15, 2016.
NeuroproteXeon is preparing to start its pivotal, 30 center, Phase III trial in the second quarter of 2018. The Company has an agreed Special Protocol Assessment ("SPA") with the United States Food & Drug Administration ("FDA") and a Scientific Advisory Working Party Agreement ("SAWP") with the European Medicines Agency ("EMA"). Both FDA and EMA have provided the Company with orphan designation on this application with related market exclusivity (seven and twelve years, respectively).