Oxygen Biotherapeutics, Inc. to Begin Oxycyte(R) Phase II Clinical Trials in Switzerland
Release Date: 2009-08-14
DURHAM, N.C., Aug. 14 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received approval to begin a Phase II, dose escalation, clinical trial in Switzerland for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier."This approval from Swissmedic means that we can begin enrolling patients," said Chris Stern, company chairman and CEO. "Our people have worked very hard to achieve this major milestone for our company. 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."
The company has named the 128 patient study "Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury" or "STOP TBI". The first patient is expected to be enrolled in September. Since study participants will all be emergency cases, it is not possible to pinpoint a date for the actual first patient.
A contract research organization (CRO), PFC Pharma Focus AG, will supervise the study. The principal investigator is Dr. Michael Reinert of the Department of Neurosurgery at the University Hospital of Berne. The Insel Hospital in Berne will be the first of the planned seven trial centers in Switzerland and four in Israel to begin enrolling patients. The other trial centers planned for the Swiss study are in Zurich, Aarau, St. Gallen, Basel, Geneva and Lausanne.
"We have a premier CRO to manage the Swiss trials and what I consider to be some of the best neurosurgeons in Switzerland as clinical investigators along with leading Swiss hospitals as study sites," said Stern. "Because of the way we are structuring the trials and the quality of the Swiss medical community, we should have data compliant with the requirements of a multi-national study that can be submitted to the FDA as well as Swissmedic."
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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