Yesterday, Oxygen Biotherapeutics, Inc. announced that the company has received approval from Israel’s Ministry of Health to begin a Phase II-b clinical trial for use of Oxycyte(R), a perfluorocarbon therapeutic oxygen carrier, in traumatic brain injuries. With four centers in Israel, the clinical trial is part of a larger study that also includes seven trial centers in Switzerland.
The company has named the study “Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury” or “STOP TBI.” The dose escalation trial aims to discover the lowest possible dose of Oxycyte that provides clinical benefit in traumatic brain injury while minimizing adverse effects. Dose levels of Oxycyte would start at 1.0 ml/kg body weight and escalate in steps to 2.0 ml/kg, and 3.0 ml/kg. Dose escalation will only occur after a favorable review of safety data by an independent Data Safety Monitoring Board.
Chris stern, company chairman and CEO, stated, “This approval from the Israeli Ministry of Health means that we can begin enrolling patients in a second country with a first class health care system. We hope this trial can provide data to show that Oxycyte is of invaluable importance in improving the outcome of patients, both civilian and military, with severe TBI. It is our goal to finally prove that there is a safe and effective treatment for this devastating injury.”