Oxygen Biotherapeutics, Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the US Naval Medical Research Center (NMRC) to conduct preclinical trials to assess the safety and efficacy of Oxygen Biotherapeutics' proprietary Oxycyte perfluorocarbon emulsion (PFCE) for the prevention and treatment of decompression sickness and related injuries.
Previously, the company signed a limited purpose CRADA for equipment and material transfer with the NMRC and Walter Reed Army Institute of Research for an investigational new drug application to use Oxycyte PFCE in treating DCS. Recently published results from US Navy studies demonstrated decreased mortality in porcine animal models that were given an intravenous dose of Oxycyte PFCE after the onset DCS. These results showed a statistically significant decrease in mortality compared with the control group that did not receive Oxycyte PFCE. This data was published in the June issue of Aviation Space and Environmental Medicine.
"We look forward to continuing our collaboration with the US Navy to develop a safe and effective treatment for DCS. We believe this new CRADA validates the potential of Oxycyte for this possible indication," said Dr. Gerald Klein, Chief Medical Officer of Oxygen Biotherapeutics.
Decompression sickness (DCS, also called the bends or caisson disease) results from inadequate decompression following exposure to increased pressure. In some cases, the disease is mild and not an immediate threat. In other cases, serious injury does occur; when this happens, the quicker treatment begins, the better the chance for a full recovery. During a deep underwater dive, body tissues absorb nitrogen from breathing gas in proportion to the surrounding pressure. As long as the diver remains at this pressure, the gas presents no problem. If the diver comes to the surface too quickly and the pressure is reduced too fast, the nitrogen comes out of solution and forms bubbles in the diver's tissues and bloodstream. Bubbles forming in or near joints are the presumed cause of the joint pain of a classical "bend." When high levels of bubbles occur, serious reactions can take place in the body, usually in the spinal cord or brain. Numbness, paralysis and disorders of higher cerebral function may result. If great amounts of decompression are missed and large numbers of bubbles enter the venous bloodstream, congestive symptoms in the lung and circulatory shock can then occur.
Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and liquid ventilation product called Oxycyte that is being formulated for both intravenous and topical delivery.