FDA Responds to Oxygen Biotherapeutics, Inc. Information Package Regarding Oxycyte Clinical Trials
January 27, 2009
COSTA MESA, Calif.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO - News) today announced that the company has received a response from the FDA to the information package filed on Dec. 23, 2008. As a result of that communication, the company was invited to request an additional meeting with the agency to discuss the steps needed to launch the next round of clinical trials for Oxycyte®. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
"We will be requesting a meeting right away and hope to schedule it as soon as possible," said Chris J. Stern, DBA, company chairman and CEO. "We have a difference with the FDA in the interpretation of the clinical data. The agency has invited us to schedule a further meeting and we welcome the opportunity to sit down with them to work toward a plan for how to proceed with Oxycyte's development. In parallel, and not to lose any time, we will continue with our regulatory plan and prepare to file for additional clinical trials in at least two other favorable locations, including Europe, without delay. We're determined to fulfill our mission and bring vital, life-saving treatment to TBI victims including our troops being crippled from unnecessary and curable brain oxygen deficit."
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®) 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.
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 additional meetings with the FDA and plans for the commencement of new clinical trials using Oxycyte. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the FDA or regulatory agencies in other countries will approve the start of additional clinical trials, that planned clinical trials will begin, that if conducted the required number of patients will be enrolled, that treatments will be successful, or that any trials will meet their endpoints. Nor can there be any assurance that Oxycyte or any company product will be approved for market in the United States or any other country for any indications. 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.