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.
Clinical studies of Oxycyte in TBI patients, placed on-hold by the FDA, are being conducted outside the United States. The second cohort of a global Phase IIB study will be launched by the end of the year. Data from the preclinical program may support data collected in patients and provide the company with a regulatory path forward in the United States. Regardless, however, the company is advancing its strategy to allow for licensing the product in any number of countries. If successful, Oxycyte could become an essential element of emergency care for TBI patients by providing fast and effective delivery of oxygen to the brain.
“The majority of the first year of this preclinical program was spent engaging contract research organizations, developing and finalizing study designs and protocols, procuring reviews and approvals from the FDA and Department of Defense for changes to the originally planned studies. In addition, a number of highly technical bioanalytical methods and animal models had to be developed. We are pleased to announce that most of the studies under the program are underway, and we are beginning to review data from recently completed studies,” said Michael Jebsen, President and Chief Executive Officer. “The successful validation of GLP GC/MS bioanalytical methods and the completion of the PK studies was a critical first step to evaluating and interpreting the data generated from the platelet and immune models currently underway.”