Synthetic Blood International, Inc. has submitted an amendment to the company's Oxycyte Investigational New Drug (IND) application to initiate a phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury. The company expects to report results from this study before the end of 2005. Oxycyte is Synthetic Blood's proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier.

Ross Bullock, chief of neurotrauma and neurocritical care, at Virginia Commonwealth University and the study's principle investigator, said, "Currently ischemic brain damage is found in 80% of patients who die of severe head injury. Approximately one third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following injury, which can lead to post-traumatic brain damage. Oxycyte presents a particularly attractive candidate for increasing cerebral oxygen delivery as earlier studies have demonstrated its potential to perfuse and oxygenate tissues in brain contusions, where capillaries are so narrow that red blood cell transport is impeded."

Robert Nicora, Synthetic Blood President and CEO said, "We are confident that Oxycyte will continue to exhibit a superior safety profile, and prove efficacious in its ability to unload oxygen more efficiently than blood. We also plan to clinically test Oxycyte as a first line therapy in other ischemic conditions such as heart attacks."

The primary purpose of this study will be to demonstrate Oxycyte's ability to increase brain oxygen tension and favourably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.

Synthetic Blood is also currently conducting a Phase II study to determine the safety and efficacy of Oxycyte in preventing tissue hypoxia in orthopaedic surgical patients (hip surgery). While blood transfusions are not typically administered during this procedure, the amount of blood lost may result in postoperative complications caused by tissue hypoxia. The company expects to complete this trial and report data by the end of 2005. The company has under development a blood substitute and a liquid ventilation product, and an implantable glucose sensor, said a release here.