Published on December 5, 2009 at 3:42 AM
Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBT) today announced that the first patient has been enrolled in the company's Phase II-b, dose escalation, clinical trial in Switzerland for use of Oxycyte(TM) emulsion in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
"This trial is of invaluable importance in improving the outcome of patients with severe TBI. We hope to finally prove that there is a safe and effective treatment for this devastating injury," said Chris Stern, company chairman and CEO. "I know that our shareholders have been wondering why it has taken so long to dose the first patient. It has taken longer than expected due to important training and logistical considerations at the trial sites. Those are being resolved on a site-by-site basis and enrollment should now start progressing. I'll go into more detail on that in my blog over the weekend. But I have to emphasize that our main criterion in the trial is safety. We therefore intentionally did not rush enrollment in the early stage. Our early competitors showed us how dangerous it is to rush a trial. We will not do that."
Out of respect for the privacy of the patients and their families, the company will not be disclosing any identifying information about patients in the study or the type of accident that caused the TBI.
The company has named the 128 patient study "Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury" or "STOP TBI". Since study participants will all be emergency cases, it is not possible to predict the precise timing of the flow of patients into the study, which is being supervised by a contract research organization, PFC Pharma Focus AG. The principal investigator is Dr. Michael Reinert of the Department of Neurosurgery at the University Hospital of Berne.
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 will 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.
SOURCE Oxygen Biotherapeutics, Inc.