Sep 23 2009
Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received approval from Israel's Ministry of Health to begin a Phase II-b, dose escalation, clinical trial in that country for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
"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," said Chris Stern, company chairman and CEO. "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."
The clinical trial with four centers in Israel is part of a larger study that also includes seven trial centers in Switzerland. The company has named the 128 patient study "Safety and Tolerability of Oxycyte in Patients 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 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 for subsequent patient cohorts. Escalation of dose will only occur after a favorable review of safety data by an independent Data Safety Monitoring Board.
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