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news.Synthetic Blood International has enrolled and treated the first patient in its phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury.
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Oxycyte is Synthetic Blood’s proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute. The formulation will be investigated in eight patients with severe traumatic brain injury.
“We are confident that Oxycyte will prove efficacious in its ability to unload oxygen more efficiently than blood,” said Robert Nicora, Synthetic Blood president and CEO.
This open label, phase II pilot study is being conducted at Virginia Commonwealth University. Oxycyte is being administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of three to nine 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 favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Animal studies have already shown that Oxycyte could be beneficial in such cases. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.