Military interest in Oxygen Biotherapeutics’ (OXBT) Oxycyte continues to be a strong driver for clinical development. The company’s phase 2b clinical trial studying Oxycyte for the treatment of traumatic brain injury (TBI), which has been enrolling at sites in Switzerland and Israel, has recently been expanded to include enrollment from the Israeli military.

We believe this could work to greatly enhance enrollment, as military blast injury (MBI) is a significant cause of TBI.  For example, there were an estimated 380k such incidences among American military personnel from 2002-2008. TBI is the largest killer in the War on Terror, and primarily occurs due to roadside blasts or bombs.

Time to treatment is a significant hurdle to reducing the severity of TBI-MBI on the battlefield. Roughly 50% of military severe TBI survivors suffer major long-term impairments. The ideal medication would be to rapidly provide oxygen-rich fluid to the damaged tissue. It must be portable, stable at room temperature, and easy to use quickly after a TBI-MBI occurs. We believe Oxycyte has these ideal characteristics. As such, we expect significant U.S. military interest in Oxycyte should the STOP-TBI program offer positive data.

Beside the potential army use in TBI and MBI, we note the U.S. Navy has been looking at Oxycyte for the potential treatment indications as well. Oxygen Bio has signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC) to conduct preclinical trials using swine models to assess the safety and efficacy of Oxycyte for decompression sickness, spinal cord injury due to decompression sickness (DCS) and hemorrhagic shock. An investigation new drug application (IND) for the treatment of decompression sickness is expected later in 2010.

In June 2010, the U.S. Navy release data from a study demonstrating decreased mortality in porcine animal models that were given an intravenous dose of Oxycyte emulsion after the onset of DCS. These results showed a statistically significant decrease in mortality compared with the control group that did not receive Oxycyte. The data was published in the June issue of Aviation Space and Environmental Medicine.

The data show a 72% 24-hour survival for the Oxycyte group vs. 45% for the control (p 
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