Oxygen Biotherapeutics, Inc.Ellen Corliss, 919-855-2112Senior Vice PresidentCorporate Communications& Investor Relations
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:
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.
"We believe that Oxycyte has tremendous potential to provide therapeutic benefit for a number of acute ischemic conditions.All branches of the military are concerned with providing the best battlefield care possible. Demand is highest for therapies that buy more time for soldiers with traumatic injuries as they are transported from remote areas to hospitals and emergency medical units. We are pleased that the Navy has expanded its interest in Oxycyte as a potential therapeutic agent for the treatment of hemorrhagic shock for our sailors and soldiers suffering acute battlefield injuries," said Michael Jebsen, President and Chief Financial Officer of Oxygen Biotherapeutics.
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 called Oxycyte that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. The company is also developing PFC-based creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care. In addition, the Company has commercialized its Dermacyte line of skin care cosmetics for the anti-aging market.
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include the expansion of development of the Oxycyte and Dermacyte product lines, the timing of the introduction of those new products, and the progress of our research programs, including preclinical and clinical testing. The forward-looking statements are subject to a number of risks and uncertainties including matters beyond the company's control that could lead to delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in our filings with the Securities and Exchange Commission, including in the current reports on Form 10-Q and Form-10K. The Company 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.