U.S. Army awards Oxygen Biotherapeutics two-year grant to study Oxycyte PFC emulsion against TBI

Mar 2 2011

Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT) today announced it has received a $2.075 million, two-year grant from the U.S. 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 U.S. 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."

TBI Incidence

According to the Department of Defense Personnel and Procurement Statistics, 75% of all U.S. 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 percent of all casualties. In a January 2006 report, the Centers for Disease Control (CDC) estimated that 1.4 million U.S. 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.