Synthetic Blood International, Inc. announced that the first patient has been enrolled and treated in its eight-patient Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury. Oxycyte is Synthetic Blood's proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
In this open label, Phase II pilot study being conducted at Virginia Commonwealth University, Oxycyte is being administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9 within 24 hours of the injury's occurrence. 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.
"About 1.4 million Americans each year sustain traumatic brain injury and there is no direct therapy for this condition. Ischemic brain damage is found in 80% of patients who die of severe head injury and about one third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following injury. We are confident that Oxycyte will prove efficacious in its ability to unload oxygen more efficiently than blood," Robert Nicora, Synthetic Blood President and CEO said adding, "Recent study data suggest that Oxycyte improves cognitive recovery following traumatic brain injury in a fluid percussion injury model, a widely accepted rat model that simulates moderate head injury with prolonged cognitive deficits sustained in humans."