Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward To Resume Oxycyte Clinical Trials In TBI In U.S.A.

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 20 Mar 2009 - 4:00 PDT

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Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) announced that the company has received a letter from the FDA that outlines what the agency termed a "path forward" as a basis to resume clinical studies of Oxycyte(R) in TBI. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.

The letter was in response to the company's request for formal dispute resolution that was submitted to the FDA Ombudsman's office. As a result, the Office of Blood Research and Review examined the reviewing division's decision to delay the start of a proposed Phase II dose escalation study of Oxycyte in traumatic brain injury (TBI).

"This outcome of the review is of great relief to us," said Chris J. Stern, company chairman and CEO. "It is helpful because it now positions the FDA to participate with the company in the development of the recommended experimental protocols to ensure their alignment with the agency's suggested path forward. This gives us the best chance to demonstrate safety of Oxycyte sufficient to move ahead in TBI in the United States," said Stern.

"In the meantime, we are moving ahead with our planned dose-escalation TBI study outside the U.S. We have expanded the trial to now include up to six sites in Switzerland and we will announce another country soon. This approach will put us on what we see as the best and fastest track for Oxycyte's clinical development while meeting the needs of all our stakeholders."

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 http://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 participation by the FDA in the development of experimental protocols to resume TBI clinical trials in the United States, plans for dose-escalation clinical trials in Switzerland and another country, 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 FDA will participate in the development of the experimental protocols, that the planned studies will provide information satisfactory to the FDA or that the FDA will allow Phase II clinical trials of Oxycyte in TBI to proceed in the United States. Nor can there be any assurance that the planned dose escalation studies in Switzerland or any other country 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.

Oxygen Biotherapeutics, Inc.
http://www.oxybiomed.com

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