Synthetic Blood Reaches First Half of Traumatic Brain Injury Trial

Synthetic Blood International, Inc. announced treatment of the fourth patient in its eight-patient Phase II proof-of-concept Oxycyte(TM) study in traumatic brain injury. Cerebral oxygen tension following Oxycyte administration was significantly increased in this patient, consistent with the results in the first three patients.

"We are pleased with the initial results at the halfway point in this trial," said Robert N. Nicora, Synthetic Blood President and CEO. "Decreased brain oxygen in severe brain injuries is implicated in poor functional outcome and even death. Brain damage as a result of decreased oxygen to the brain is found in about 80% of patients that die with severe head injuries. Animal and clinical studies have shown that increasing brain oxygen in such patients improves functional outcome, and Oxycyte has been shown to be an effective means of delivering oxygen to tissues, including the brain. The fact that we have seen increased oxygen levels in all four study patients strengthens our belief that administering Oxycyte to patients with traumatic brain injury and other ischemic states could improve clinical outcomes."

The Phase II pilot study protocol includes two groups. The first four study patients were stabilized with 50% oxygen for four hours before and 12 hours following Oxycyte administration. The remaining four study patients will breathe 100% oxygen on the same schedule. Clinical data on brain oxygen and metabolite levels will be compared in patients from both groups.

In this open label, Phase II pilot study being conducted at Virginia Commonwealth University, Oxycyte is administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. The primary purpose of this study is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably 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.