DURHAM, N.C., Aug. 14 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.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and Defense Medicine(TM). The company has under development a perfluorocarbon (PFC) therapeutic oxygen carrier and liquid ventilation product (Oxycyte(R)) and has out-licensed an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs as well as medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including traumatic brain injury, sickle cell crisis, trauma, wound care, decompression sickness, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, diabetes wounds and ulcers and cosmetic applications. More information is available at www.oxybiomed.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include those referring to the start of a Phase II clinical trial in Switzerland for Oxycyte in TBI and time frame estimate for enrolling patients. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that a sufficient number of patients will be enrolled in the trial nor any assurance of the outcomes. Additional information concerning these and other risk factors affecting Oxygen Biotherapeutics, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via www.oxybiomed.com. Oxygen Biotherapeutics, Inc. disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
SOURCE Oxygen Biotherapeutics, Inc.