DURHAM, N.C., Sept. 7, 2010 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT), a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced that Israeli soldiers who suffer severe traumatic brain injury (TBI) can be enrolled in the company's Phase II-b STOP-TBI trials at clinical sites in Israel. In view of this development, the company announced that it seeks to amend the existing study protocol to broaden the qualified patient enrollment population to include moderate/mild TBI patients. The company expects to reconvene enrollment in its second cohort after the required regulatory adjustments have been approved. The result of these two actions should increase the patient population that qualifies for enrollment in the study.
"Today, traumatic brain injury is one of the most common impairments faced by our military personnel all over the world. Land mines, rocket-propelled grenades and improvised explosive devices are now the most common tools of war. When they strike, body armor and helmets may protect, but what is not as easily recognizable is the damage these weapons are doing to service members' brains. Sometimes it is an obvious injury; other times it is mild to moderate. Therefore, we are considering modifying our study protocol to include moderate/mild TBI cases. As a company, we believe it is our duty to help these men and women who otherwise have little to no solution when afflicted with a brain injury. We are pleased that the Israeli Medical Corps will allow soldiers to participate," said Chris Stern, Chairman and Chief Executive Officer of Oxygen Biotherapeutics.
Currently, Oxygen Biotherapeutics has a Phase II-b clinical study underway to determine the safety and efficacy of using Oxycyte intravenously to treat severe TBI patients. These studies are being conducted at clinical sites in Switzerland and Israel with plans to expand into India. The company expects to allocate a substantial portion of its financial and business resources over the next few years to testing Oxycyte and advancing this product to regulatory approval for use in one or more medical applications.