U.S. Navy Broadens CRADA With Oxygen Biotherapeutics To Include Preclinical Studies Assessing Oxycyte(R) For Spinal Cord Injury Due To Decompression Sickness And For Hemorrhagic Shock
DURHAM, N.C., Sept. 20, 2010 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT) today announced it has amended an existing Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC) to include preclinical trials using swine models to assess the safety and efficacy of Oxygen Biotherapeutics' proprietary Oxycyte ® perfluorocarbon emulsion (PFCE) for spinal cord injury (SCI) due to decompression sickness (DCS), and for hemorrhagic shock.
The protocol for the spinal cord injury trial will measure safety and efficacy of Oxycyte in conjunction with recompression therapy. The hemorrhagic shock protocol will look at using Oxycyte for preservation of systemic oxygenation in large porcine models.
"We are pleased that the Navy broadened the existing CRADA to include additional indications for its preclinical studies with Oxycyte," said Chris Stern, Chairman and Chief Executive Officer of Oxygen Biotherapeutics. "If studies show that Oxycyte safely and effectively carries oxygen to deprived organs quickly and, in the case of decompression sickness, removes dangerous levels of nitrogen from tissues, it may improve emergency medical responses to soldiers and civilians facing traumatic injuries."About Spinal Cord Injury and Hemorrhagic Shock Severe forms of decompression sickness include spinal cord injury, possibly from gas bubbles causing direct tissue damage or obstruction of blood supply to the spinal cord. An SCI is damage or trauma to the spinal cord that results in the loss of or impaired function causing reduced mobility or feeling. Besides DCS, other causes of SCI are trauma (i.e., vehicular accidents, gunshots, falls, sport's injuries) or disease (i.e., transverse myelitis, polio, spina bifida). The spinal cord does not have to be severed in order for a loss of functioning to occur. In most people with SCI, the spinal cord is intact, but the cellular damage to it results in its loss of function. Shock is a state of inadequate perfusion, which does not sustain the physiologic needs of organ tissues. Many conditions, including blood loss, but also including non-hemorrhagic states such as dehydration, sepsis, impaired autoregulation, obstruction, decreased myocardial function, and loss of autonomic tone, may produce shock or shock-like states. In hemorrhagic shock, blood loss exceeds the body's ability to compensate and provide adequate tissue perfusion and oxygenation. This frequently is due to trauma, but it may be caused by spontaneous hemorrhage (e.g., gastrointestinal bleeding, childbirth), surgery, and other causes.
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