Oxygen Biotherapeutics Receives Approval For Oxycyte

Oxygen Biotherapeutics has received approval from Israel’s Ministry of Health to begin a phase II-b, dose escalation, clinical trial in the country for use of Oxycyte in traumatic brain injury (TBI). Oxycyte is the company’s perfluorocarbon (PFC) therapeutic oxygen carrier.

The company said that the clinical trial with four centers in Israel is part of a larger study that also includes seven trial centers in Switzerland. The trial will study safety and tolerability of Oxycyte in 128 patient with Traumatic Brain Injury or STOP TBI.

The dose escalation studies will focus on finding the lowest dose of Oxycyte that provides clinical benefit in traumatic brain injury while minimising adverse effects. Dose levels of Oxycyte would start at 1.0ml/kg body weight and escalate in steps to 2.0ml/kg, and 3.0ml/kg for subsequent patient cohorts.

Chris Stern, chairman and CEO of Oxygen Biotherapeutics, said: “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.”