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Oxygen Biotherapeutics, Inc. To Meet With FDA to Discuss Proposed Phase II-B Oxycyte Clinical Trial

Posted on: Monday, 25 August 2008, 09:01 CDT

Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that the company will meet with the U.S. Food and Drug Administration (FDA) to discuss two remaining issues that the agency has about the use of Oxycyte(R) in a proposed Phase IIb clinical trial in Traumatic Brain Injury (TBI). The meeting will be requested next week and is expected to be scheduled within 30 days after the agency has received the request. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

In parallel, the company will file an expedited response to the latest two concerns communicated by the agency and provide the information required to resolve them.

"The good news is that we are back on the critical path with our study. We hope to put this slight delay to our advantage and use the meeting to align the clinical and non-clinical development plan for TBI with an eventual registration program. We believe an additional month is therefore time very well invested. The FDA takes very seriously its responsibilities in examining a proposed test of a drug that will be injected into seriously injured people. We are convinced that the constructive engagement of the FDA at this juncture will expedite the process overall and potentially save us months in the timeline to move from Phase II to Phase III," said company chairman and CEO Chris J. Stern, DBA.

The company plans to continue its open communication about results, but will not go into further details about 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.

"In the meantime we will continue to keep working on our additional priority indications for Oxycyte, including new wound-care applications, sickle cell pain crisis, and other topical indications," said Stern. "The strategy of becoming a multi-product company is definitively to our advantage. I believe our topical indications will more than compensate for delays in clinical processes. We plan to establish our Topical division in the fourth quarter and it will be their goal to have a first product on the market in 2009."

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 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 the expected commencement of clinical trials in Traumatic Brain Injury, the creation of a Topical division, use of Oxycyte in wound care and sickle cell pain crisis, and plans to market a new topical product. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance 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. Nor can there be any assurance that plans to create a new division will be realized in the time frame planned or at all. 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: Business Wire

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