Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a development stage biomedical company focused on developing oxygen-carrying intravenous and topical products, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Unit of San Antonio (NAMRU-SA) to assess the safety and efficacy of Oxycyte ® as well as hemoglobin-based oxygen carriers (HBOC) as potential resuscitation treatments for hemorrhagic shock. This latest CRADA is in addition to separate, ongoing research programs in which the U.S. Navy is exploring the therapeutic potential of Oxycyte in the areas of decompression sickness and traumatic brain injury.
Circulatory system collapse (shock) following acute hemorrhage continues to be the leading cause of preventable battlefield death and is also frequently seen in the civilian population in victims of vehicular accidents and shootings. Hemorrhagic shock is characterized by hemodynamic instability that leads sequentially to decreases in oxygen delivery, lowered tissue perfusion, cellular hypoxia, organ damage, and, often, death. The success of current treatment modalities, which include introduction of IV fluids and blood products, are time dependent and often problematic, particularly on the battlefield. Intravenous oxygen–carrying therapeutic agents have the potential to improve survival by providing oxygen to tissues, maintaining blood pressure, and reducing or preventing hemorrhagic shock following acute battlefield injury prior to hospitalization.
Per the terms of this most recent CRADA, NAMRU-SA will conduct a multi-phased, three-year research program to study several oxygen based therapies in rat and swine models of hemorrhagic shock. Endpoints of the research include:
- direct tissue arteriole diameter measurements to assess vasoactivity
- comparing standard measurement of oxygen delivery to direct tissue oxygen concentrations
- determining if there are any effects of oxidative stress, inflammation and apoptosis
Oxygen Biotherapeutics will provide NAMRU-SA with existing information related to the development of its perfluorocarbon-based drug candidate, Oxycyte, including safety data from the company’s studies in animals and humans. In addition, Oxygen Biotherapeutics will provide ongoing guidance regarding optimal approaches to Oxycyte administration and dosing. Oxycyte will be transferred from the company to the NAMRU-SA under a separate material transfer agreement (MTA). All reimbursements under the MTA will be used to offset our ongoing development costs.