COSTA MESA, Calif., March 26 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. today announced that the company has added clinical trial sites in Israel for the planned Phase II dose escalation study of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the company’s perfluorocarbon (PFC) therapeutic oxygen carrier. The Israeli sites are in addition to those previously planned for Switzerland.
“Israeli physicians are excited to be able to participate in this study, especially as it relates to TBI as a result of blast injury,” said Chris J. Stern, company chairman and CEO. “Unfortunately, they have had to deal with blast victims for some time, both military and civilian. They see this as something that can help them improve outcomes for the victims they treat. They also have one of the best medical systems in the world and are especially skilled in treating TBI. So the data they collect should be absolutely first rate,” said Stern.
Plans call for up to six treatment sites in Israel, the same number as in Switzerland. They will also use the same clinical protocol. All trials will be supervised by the Israeli affiliate of PFC Pharma Focus AG, a Swiss-based contract research organization. The company expects to begin the clinical trials in the second quarter.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The company has under development a perfluorocarbon therapeutic oxygen carrier and liquid ventilation product (Oxycyte(R)) and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs and 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 pain, trauma, wound care, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, and diabetes. 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. The forward-looking statements include those referring to plans for dose-escalation clinical trials in Switzerland and Israel, the expected time frame for the beginning of those trials, and hoped-for data from those trials. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the planned dose escalation studies in Switzerland and Israel will start in the expected time frame nor can there be any assurance that they will not be delayed by regulators there, or that those studies, when conducted, will be successful or provide data acceptable to the FDA. 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.
CONTACT: Abe Wischnia of Abe Wischnia & Associates, +1-619-795-2345; or
European Media, Jessica Walther of Prime Communications AG, +41 44 287 36
80, both for Oxygen Biotherapeutics, Inc.
Web site: http://www.oxybiomed.com//
