Oxygen Biotherapeutics, Inc. announced it has received a $2.075 million, two-year grant from the US Army to study the company's proprietary Oxycyte PFC emulsion as a therapeutic intervention focused on reducing brain damage in victims of traumatic brain injury (TBI).

Perfluorocarbon (PFC) emulsions, as a therapeutic class, are known to interact with the reticuloendothelial system as part of the clearance mechanism, as well as affect the number of circulating platelets. The preclinical studies supported by this grant will examine the effects of Oxycyte on the immune system, platelet function and distribution, as well as the safety and efficacy of platelet transfusion, which can be necessary for patients with TBI and related polytrauma. Additionally studies will be conducted to further evaluate the pharmacokinetics of PFCs in relevant species to aid in data interpretation. These studies will help determine the safety profile of Oxycyte PFC emulsion.

"Hemostasis and immunocompetence are critically important in severe TBI patients. The studies supported by this Army grant will augment our data and knowledge of the safety and efficacy of perfluorocarbon emulsions," said Gerald L. Klein, MD, Principal Investigator and Chief Medical Officer of Oxygen Biotherapeutics. "We believe Oxycyte PFC emulsion may have the potential to help reduce the effects of traumatic brain injury rather than merely improve stabilization following the traumatic occurrence."

Added Oxygen Biotherapeutics' chairman and CEO Chris Stern: "We are proud to work with the US Army to develop new treatments that will benefit our soldiers, as well as civilians. We believe this research grant will give us the important information we need to move Oxycyte down the clinical development path."

According to the Department of Defense Personnel and Procurement Statistics, 75% of all US military casualties of Operation Enduring Freedom and Operation Iraqi Freedom are caused by explosive weaponry, resulting in TBIs and blast-induced neurotrauma, which have been called the "signature wounds" of these wars. They estimate that TBI accounts for about 22 per cent of all casualties. In a January 2006 report, the Centers for Disease Control (CDC) estimated that 1.4 million US civilians sustain TBI each year. Of them, about 50,000 die, 235,000 are hospitalized and 1.1 million are treated and released from an Emergency Department. An estimated 80,000-90,000 people with TBI experience permanent disability from their injury. These incidence rates have led the CDC to conclude that TBI prevention, improved acute care and rehabilitation to reduce the likelihood of TBI-related disability, and increased access to services for those who do not fully recover must continue to be national priorities.

Oxycyte is an emulsion of a proprietary PFC-based oxygen carrier. The physical properties of PFCs enable Oxycyte to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Over a period of days following administration, Oxycyte is gradually cleared from the body through the lungs in the course of respiration. Oxycyte requires no cross matching, so it is immediately available and compatible with all blood types. It is provided to our researchers as a sterile emulsion ready for intravenous administration. Because it contains no biological components, there is no risk of transmission of blood-borne viruses from human blood products.

Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte that is being formulated for both intravenous and topical delivery for conditions including but not limited to traumatic brain injury, decompression sickness and topical wounds as well as cosmetic applications.