Oxycyte Development Moving Forward - Analyst Blog

Preclinical SCI Data Shows Encouraging Neuroprotection

On June 3, 2010, Oxygen Biotherapeutics (OXBT) reported that two preclinical studies demonstrated Oxycyte delivered marked neuroprotective effects in a rat model of spinal cord injury. The data show histologically, Oxycyte improved the volume of preserved neuronal tissue in the spinal cord following injury.

The data also show a favorable improvement in functional recovery as assessed by footprint analysis six weeks post-treatment. The study was entitled, “Possible Role of Hyperbaric Oxygen Therapy (HBO) and Oxycyte After Spinal Cord Injury in Rats," and will be part of the poster sessions at the National Neurotrauma Symposium on June 14-16, 2010 at the Paris Hotel in Las Vegas. Results of the first study entitled "Evaluation of the Neuroprotective and Behavioral Effects of the Perfluorocarbon Oxycyte After Spinal Cord Injury (SCI) in the Rat" were presented in September 2009 at the annual National-International Neurotrauma Symposium by Dr. Ross Bullock, University of Miami Miller School of Medicine. Both studies received funding from Oxygen Biotherapeutics.

This is encouraging preclinical data and allows management to move closer toward filing an investigation new drug (IND) application in spinal cord injury, perhaps later in 2010. According to statistics from various studies compiled by the National Spinal Cord Injury Statistical Center in Birmingham, AL, an estimated 12,000 new cases of spinal cord injury occur each year in the U.S. The number of people living in the United States with SCI is estimated to be approximately 260,000 people. Neuroprotection with Oxycyte remains a core focus for the company.  The company is currently seeking a development partner for SCI.

Phase II TBI Program Ongoing

The company’s phase IIb traumatic brain injury (TBI) program, STOP-TBI (Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury), has continued to enroll patients since December 2009. In May 2010, management formalized a working relationship with site monitoring company to assist in the enrollment and expansion of the program. Management will use the site monitoring company to expand the program into five clinical sites in India. The program is designed to enroll 98 patients presenting to the emergency room with severe, non-penetrating traumatic brain injury at sites in Switzerland (11 sites), Israel (4 sites) and India (5 sites).

The dose escalation study will focus on finding the lowest dose of Oxycyte that provides clinical benefit in traumatic brain injury while minimizing adverse effects.  Dose levels of Oxycyte will start at 1.0 ml/kg body weight and escalate in steps to 2.0 ml/kg, and 3.0 ml/kg for subsequent cohorts. Escalation will only occur after a favorable review of safety data by an independent Data Safety Monitoring Board (DSMB).

In May 2010, management held an investigator meeting with all participating sites. No results have yet been reported, but we anticipate an update from the first cohort perhaps later this year. The second (45-50 people) and third (35-40 people) cohorts are on track to begin enrolling following the interim analysis of the first cohort. Full data is expected in 18 months.

According to the CDC, there are approximately 1.5 million people who suffer from a traumatic brain injury in the U.S. each year, about 20% of which are severe (300k). Causes of TBI are diverse, with the top three being: motor vehicle crashes, firearms and falls. TBI is the #1 cause of disability among those under the age of 35. Roughly 50k people die from TBI each year and 100k people suffer long-term disabilities post-injury. In the U.S. alone, more than 5.3 million people are currently living with long-term disabilities caused by TBI. The average cost of care for someone post a severe TBI is between $50k and $75k per year.

Early-stage clinical work conducted by Oxygen Biotherapeutics demonstrates that 40% to 70% of damaged brain tissue can be saved by Oxycyte post TBI. Preclinical animal studies demonstrated that rats treated with Oxycyte following a lateral fluid percussion injury (LFPI) had statistically superior scores (lower times to complete) on Morris water maze tests than rats receiving saline solution only.

Military Interest in Oxycyte Growing

Another major cause of TBI is Military Blast Injury (MBI). 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. That’s Oxycyte! As such, we expect significant U.S. military interest in Oxycyte should the STOP-TBI program offer positive data.

We note the U.S. Navy is also looking at Oxycyte for the potential treatment of decompression sickness. An IND for this indication is expected later in 2010. Approval for use of Oxycyte by the U.S. Navy based on animal-rule data could come by 2012. This could be a significant opportunity for Oxygen Bio based on the characteristics of the drug and the potential for broad-scale deployment on U.S. or NATO submarines.

In a bullish scenario, we envision the U.S. Navy purchasing Oxycyte for its 250 – 300 submarines with an estimated 100 to 120 doses per ship. The same characteristics that make Oxycyte attractive to the U.S. Army -- portable, stable at room temp, easy to use -- also fit well within what the U.S. Navy would be looking for on a disabled vessel.
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