COSTA MESA, Calif., Jul 30, 2008 (BUSINESS WIRE) — Oxygen Biotherapeutics, Inc. OXBO today announced that a study to be published in the August 2008 edition of the “Journal of Neurosurgery: Spine” demonstrates that Oxycyte(R) can help reduce damage caused by oxygen shortages in a spinal cord injury model. Oxycyte is the Company’s perfluorocarbon (PFC) therapeutic oxygen carrier.
The investigators in the study and authors of the article are Jason L. Schroeder, M.D., Jason M. Highsmith, M.D., Harold F. Young, M.D., and Bruce E. Mathern, M.D. All are with the Department of Neurosurgery, Virginia Commonwealth University Health System in Richmond, Virginia.
Few therapies have consistently demonstrated effectiveness in preserving oxygen delivery after spinal cord injury (SCI). The researchers measured oxygen levels in rats in two studies to establish a dose response curve. The pressure of oxygen levels dissolved in the blood in spinal cord injury showed a profound drop from 21.4 to 10.4 mm Hg almost immediately post injury. In the relevant experiment, all animals that received Oxycyte combined with 100% oxygen showed significant improvement, with a mean increase in oxygen levels of 23.3 mm Hg. Only one saline-treated animal in the control group showed any benefit. Oxygen values in the group treated with Oxycyte reached up to six times the normal level.
“The laboratory investigation suggests that administration of a perfluorocarbon with the characteristics and performance of Oxycyte combined with 100% oxygen therapy can reverse tissue oxygen deficit and holds promise for reducing ischemic injury,” said Bruce D. Spiess, M.D., Professor Anesthesiology and Emergency Medicine, VCURES/VCU Med Center Richmond, Virginia, and co-chair of the Oxygen Biotherapeutics Medical Advisory Board.
“Traumatic spine injury is a major cause of long-term Disability for our troops in the war zones as well as 200,000 plus civilian injuries per year. If we could develop a rapid technique to salvage as much function as possible immediately after injury, this would be a major breakthrough in spine trauma. The key to tissue salvage may well be immediate oxygen delivery to tissues at risk,” said Dr. Spiess.
“This is exciting news for Oxygen Biotherapeutics, Inc.,” said company chairman and CEO Chris J. Stern, DBA. “We’ve always known what our compound is capable of. Now, this latest research shows the possibility of yet another indication for treatment with Oxycyte in addition to those we’ve previously discussed, potentially broadening our product portfolio. If this early research translates to humans, Oxycyte could have a significant impact on the lives of spinal cord injury victims.”
The company provided the Oxycyte to the researchers at no charge but did not provide any other financial support or sponsorship.
The company also said that it is in continuing, positive communication with the FDA regarding the protocol for its proposed Phase IIb clinical trial of Oxycyte in traumatic brain injury. “The FDA is working with us and reviewing all our data,” said Dr. Richard Kiral, company president, COO, and chief scientific officer. “They’re asking questions and we’re providing answers. The agency is doing their work very diligently and we will continue to invest the time it takes to bring this process to the outcome we all want. It is in everybody’s interest to establish a fully-reviewed trial protocol that can lead our product to market.”
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 references to potential applications of Oxycyte in treating spinal cord injuries, the potential benefits of Oxycyte, forecasts of the company’s prospects for a product portfolio and planned clinical trials using Oxycyte. Actual events or results may differ from the company’s expectations. There can be no assurance that any future research using Oxycyte in spinal cord injury treatment will be undertaken or that if done will be successful or that the results of the reported animal study will have any similar outcome in humans. Nor can there be any assurance that the FDA will approve the company’s proposed Phase IIb clinical trial in traumatic brain injury, that if conducted any such trial will be successful, that Oxycyte will be approved for market by the FDA, or that if approved will gain market acceptance. 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: Oxygen Biotherapeutics
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Copyright Business Wire 2008