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).
About NeuroproteXeon
NeuroproteXeon, Inc. is a clinical-stage pharmaceutical/device company developing xenon to improve functional capabilities and survival in patients with Post-Cardiac Arrest Syndrome ("PCAS"). The Company has a license agreement with Mallinckrodt LLC for the sale and distribution of xenon gas for inhalation in North America, Australia and Japan upon approval of the drug in those markets.
Contact: Matt Napoletano, [email protected]716-332-7200 ext. 146http://neuroprotexeon.com
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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.
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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).
About NeuroproteXeon
NeuroproteXeon, Inc. is a clinical-stage pharmaceutical/device company developing xenon to improve functional capabilities and survival in patients with Post-Cardiac Arrest Syndrome ("PCAS"). The Company has a license agreement with Mallinckrodt LLC for the sale and distribution of xenon gas for inhalation in North America, Australia and Japan upon approval of the drug in those markets.
Contact: Matt Napoletano, [email protected]716-332-7200 ext. 146http://neuroprotexeon.com
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