ORCHARD PARK, N.Y., Nov. 28, 2017 /PRNewswire/ -- NeuroproteXeon, Inc. announced the publication of a second finding from
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).
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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