COSTA MESA--- Oxygen Biotherapeutics, Inc. Announces Plans for Additional Oxycyte® Phase II Clinical Trials
COSTA MESA, Calif.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced plans to file a Phase II, dose escalation, clinical trial protocol in Switzerland for use of Oxycyte® in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The announcement came in a presentation today by Chris J. Stern, DBA, company chairman and CEO, at the BIO CEO & Investor Conference in New York. During the presentation, Stern said that the company is in the final stages of preparation to file the protocol in Switzerland. “Depending on the timing of the review process there, we could begin enrolling patients in the second quarter,” said Stern.
In addition, Stern said in the presentation that the company is targeting to have a topical wound care product ready to come to market as early as the end of 2009.
After the conference presentation, Stern added, “We’re pushing ahead with our Oxycyte Phase II plans without waiting for the FDA. When we received the recent letter from them informing us, that after reviewing our data, they are not yet ready to allow us to resume clinical trials in traumatic brain injury, we were surprised with their conclusion. But we’re not going to stop our Oxycyte development while we work on resolving our disagreement with the agency. Rather than lose any more time, we will be filing in Switzerland before the end of this month the same protocol that we intend to submit to the FDA. If this moves along at the pace that I expect, we could be seeing data on results in the summer. As I stated in my blog, Swiss trial data can be submitted in the U.S. as well. It is still our intent to keep moving ahead in this country also and have double enrollment, but we have mitigated the dependency on one single regulatory agency.”
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 plans for the submission of a Phase II clinical trial protocol in Switzerland for Oxycyte in TBI, time frame estimates for enrolling patients, time frame estimates for seeing data on results and the company’s plans for having a wound care product on the market. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the regulatory agencies in Switzerland or any other country will approve the planned submission or the start of additional clinical trials, that planned clinical trials will begin in the estimated time frame or at all, that if conducted the required number of patients will be enrolled, that treatment data will be available in the estimated time frame, that treatments will be successful, or that any trials will meet their endpoints. Nor can there be any assurance that the company will receive the necessary approvals to bring a wound care product to market in 2009 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.