Synthetic Blood enrolls first patient in phase 2 traumatic brain injury study

By E. Janene Geiss

Philadelphia, March 16 - Synthetic Blood International, Inc. said Thursday that the first patient has been enrolled and treated in its eight-patient phase 2 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 therapeutic oxygen carrier and blood substitute, according to a company news release.

"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, president and chief executive officer, said in the release.

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, officials said.

In this open-label, phase 2 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 to 9 within 24 hours of the injury's occurrence.

The primary purpose of the study will be 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.

The study also will further assess the safety of Oxycyte when given by intravenous infusion, officials said.

Synthetic Blood is a Costa Mesa, Calif., pharmaceutical and medical device company focused on the fields of oxygen therapeutics and continuous substrate monitoring. The company has under development a blood substitute and a liquid ventilation product, and an implantable glucose sensor. Each of the product candidates is designed with advantages over currently marketed products in major markets including acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes.

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