Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that it will submit an amended test protocol to the FDA and almost simultaneously in Canada to cover dose escalation studies of Oxycyte® in Traumatic Brain Injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier. The company intends to file the amended protocol in global format, which allows for submission in the U.S. and other countries, within approximately 50 days.
Under the revised protocol, the company intends to enroll 40 TBI patients in each country. Each trial will be a dose escalation study with three cohorts of ten in the test arm and ten patients in the control. Each cohort will be assigned a dose level in the order of their entry into the study, with ten patients enrolled at each increasing dose level. Patients – both treated and control groups – will be followed for six months after treatment.
Both the U.S. and Canadian studies will be designed as multi-center studies focusing on finding the lowest dose of Oxycyte that reduces thrombocytopenia and still provides clinical benefit in traumatic brain injury. Both studies will additionally be designed to study the widely unexplored correlation between platelets and thrombocytopenia and have the potential to solve a number of unresolved problems in other drugs.
Due to the slight redesign of the protocol and FDA administrative processes, patient enrollment is anticipated to begin in the first quarter of 2009. A possible additional study in Switzerland is under review and a decision on that will be made in the near future.
“Personally, I think that the extensive data we will collect in the dose escalation studies should be more than needed for proof-of-concept in both safety and efficacy. The advantage is that we should have the data we need much earlier, after each cohort of ten, rather than after 200 patients as it was previously planned. Another important advantage is that this approach could save us a substantial amount of money – perhaps as much as 50% compared to the original Phase IIb design. Most importantly, having good data sooner could give us a much earlier opportunity to reach out to potential license partners,” said company chairman and CEO Chris J. Stern, DBA.
Part of the dose escalation study will be financed through a previously-announced $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 traumatic brain injury trial protocol with Oxycyte.
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 those referring to plans for the submission of an amended clinical trial protocol, commencement of new clinical trials in Traumatic Brain Injury, cost savings from the amended protocols, hoped-for data showing safety and efficacy, timing of availability of such data, and its impact on interest by potential license partners. Actual events or results may differ from Oxygen Biotherapeutics, Inc.’s expectations. There can be no assurance that the amended protocol will be approved as submitted in either the United States or Canada or any other country, that planned clinical trials will begin in the estimated time frame, that if conducted the required number of patients will be enrolled, that treatments will be successful, that any trials will meet their endpoints, or that any cost savings, if realized, will be of the level estimated. Nor can there be any assurance that data from the proposed trials will lead to any interest by other companies in any type of partnering or licensing agreement. There also can be no 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.
Contacts:
Abe Wischnia, 619-795-2345
