News Updates

Test Protocol For TBI Cure Approved By The European Commission

June 15, 2009 -  Testing to evaluate the safety and tolerability of Oxycyte in patients with severe Traumatic Brain Injury (TBI) has been approved by the European Commission. The study  will take place at approximately ten study sites: approximately 6 in Switzerland and approximately 4 in Israel. It is planned that 128 patients will participate. The study will encompass a randomized, placebo controlled, double-blind, single-dose and dose escalation program among male and female patients between the ages of 18 and 77.

A third-generation perfluorocarbon(PFC) therapeutic oxygen carrier under development by Oxygen Biotherapeutics, Inc., Ocycyte is designed to enhance oxygen delivery to damaged tissues. When used as an intravenous emulsion, Oxycyte can carry as much as five times more oxygen than hemoglobin, making it an effective means of transporting oxygen to tissues and carrying carbon dioxide to the lungs for disposal. Oxycyte is not a blood substitute. Because it is a PFC, and not based on hemoglobin, it does not have the safety issues associated with hemoglobin-based products.

Scheduled to begin shortly, the trials in Switzerland and Israel will compare safety and tolerability as measured by several factors. A total of up to three doses will be examined. The primary objective is to determine that Oxycyte can reduce mortality, reduce the severity of brain injury and improve functional outcomes in patients with severe non-penetrating brain injury.

TBI is the largest cause of death and disability in young persons under 40, and a major source of severe injuries in war zones.  There are currently no cures and few treatments for TBI.