Oxygen Biotherapeutics, Inc. Sets FDA Meeting Date For Proposed Phase IIb Oxycyte Clinical Trial

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 12 Sep 2008 - 5:00 PDT

email to a friend   printer friendly   opinions  

Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that the company is tentatively scheduled to meet with the U.S. Food and Drug Administration (FDA) during the week of Oct. 20, 2008 to discuss any remaining issues that the agency has about the use of Oxycyte® in a proposed Phase IIb clinical trial in Traumatic Brain Injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier. The meeting date and time are subject to final confirmation by the agency.

"At that meeting, we will be extensively prepared to resolve any remaining issues and concerns the FDA may have," said company chairman and CEO Chris J. Stern, DBA. "We view this as a positive development, as the agency has also offered to review the Company's overall development plan. This may contribute to reducing regulatory risk at future stages such as Phase III. We will constructively use the dialog and its documentation process to align the clinical and non-clinical development plan for TBI with potential endpoints for Phase III and towards an eventual registration."

As previously stated, the company believes it is in the best interests of the process to continue its open communication about results, but not to go into further details about the meeting or discussions with the FDA.

The company's planned multi-center, double-blind, placebo-controlled study would enroll up to 300 patients. 200 patients will be allowed for enrollment through a $1.9 million grant from the United States Department of Defense to M. Ross Bullock, M.D., Ph.D., of the University Of Miami Miller School Of Medicine, Department of Neurosurgery. Dr. Bullock is the principal investigator for the planned Phase IIb clinical trial. The company plans to do an interim analysis after enrolling 100 patients and then may elect to enroll up to 300. The timing of the start of the Phase IIb trial depends on the outcome of the FDA review process.

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 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 acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, visit 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 predictions about meetings with the FDA and the expected commencement of clinical trials in Traumatic Brain Injury. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that there will be no delay in the meeting schedule, that the company will receive permission to commence the clinical trials, that the required number of patients will be enrolled, that any interim analysis will result in positive data, that any trials will meet their endpoints, or that Oxycyte or any company product will be approved for market by the FDA 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 http://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.

• Additional
• References
• Citations