Published Study Demonstrates Oxycyte Can Improve Cognitive Recovery And Reduce Neuronal Cell Loss After Traumatic Brain Injury in Animal Model
COSTA MESA, Calif.--(BUSINESS WIRE)--Nov 11, 2008 - Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that a study published in the October 2008 edition of the journal Neurosurgery demonstrates that Oxycyte(R) can improve cognitive recovery and has a protective effect on hippocampal neurons in an experimental Traumatic Brain Injury (TBI) model in rats. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The investigators in the study and authors of the article are Zhengwen Zhou, M.D.; Dong Sun, M.D., Ph.D.; Joseph E. Levasseur, M.S.; Amedeo Merenda, M.D.; Robert J. Hamm, Ph.D.; Jiepei Zhu, Ph.D.; Bruce D. Spiess, M.D.; of Virginia Commonwealth University and M. Ross Bullock, M.D., Ph.D. who is with the University of Miami, Miller School of Medicine.
In the study, test animals were divided into two groups and treated with either a low dose or a high dose of Oxycyte and breathed 100 per cent oxygen after an induced injury. Control animals were given saline.
The researchers found that injured animals treated with a lower or higher dose of Oxycyte had significant improvement in ability to learn and function in a standard maze when compared with injured saline control animals. The ability to learn and perform complex tasks (a maze) are the ultimate tests of higher brain function. Moreover, injured animals that received either dose of Oxycyte had significantly less brain damage compared with saline-treated animals. They also found that a lower dose of Oxycyte significantly improved cells' ability to process and use oxygen.
"This study lends additional weight to what we believe about the potential benefits of Oxycyte in TBI. If Oxycyte can provide improved cognitive function in TBI patients, it can make a huge difference in their recovery and quality of life," said company chairman and CEO Chris J. Stern, DBA. "As we've previously announced, we intend to submit an amended test protocol to the FDA to cover dose escalation studies of Oxycyte in TBI. This latest published animal study suggests that a lower dose of Oxycyte may have the same benefit as a larger one. The next round of clinical trials should tell us."
The new studies will be designed as multi-center studies focusing on finding the lowest dose of Oxycyte that reduces the platelet reduction (thrombocytopenia) and still provides clinical benefit in traumatic brain injury. Both studies will additionally be designed to study the widely unexplored correlation between platelets/thrombocytopenia and the scientific reasons why perfluorocarbons can cause such an effect. Knowing the mechanism behind any platelet drop could have the potential to solve a number of unresolved problems in other drugs.
Due to the slight redesign of the protocol and regulatory and administrative processes, patient enrollment is anticipated to begin in the first quarter of 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 (Oxycyte(R)) 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. 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 and potential outcomes of new clinical trials in Traumatic Brain Injury. 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 patient enrollment will begin in the time projected frame or at all, that if conducted the required number of patients will be enrolled, that treatments will be successful, or that any trials will meet their endpoints. 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.
Abe Wischnia & Associates
Posted: November 2008