Oxygen Biotherapeutics, Inc.’ Update on US Army-Funded Preclinical Studies Designed to Support the Safety Profile of Oxycyte PFC Emulsion Currently in Clinical Trials Overseas for Traumatic Brain Injury
Published: Oct 25, 2012
MORRISVILLE, N.C.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT), a development stage biomedical company currently focused on developing its proprietary perfluorocarbon-based intravenous emulsion, Oxycyte®, as a treatment for a variety of emergent ischemic conditions, today reported that the U.S. Army-funded preclinical program that was established to address the U.S. Food and Drug Administration (FDA) questions regarding the product, is well underway with several important milestones complete or nearing completion. Perfluorocarbon emulsions as a class have been shown to cause transient thrombocytopenia in animals and humans and, because of emulsion particle clearance mechanisms, have raised questions regarding their potential impact on normal immune system function. To continue the clinical development of Oxycyte in the United States, the FDA has requested studies to explore in detail the safety profile of Oxycyte with respect to these putative effects. With this preclinical work, OBI has moved several steps closer to addressing the questions posed by the FDA regarding thrombocytopenia, platelet function, and immunocompetence.