Clinical Trail to begin First Quarter 2009 for TBI Treatment
As an effort to keep medical consumers apprised of the latest advances in potential medical answers to tough medical issues, it is with interest that we inform readers of a new treatment for Traumatic Brain Injury that is peeking on the horizon. After a positive meeting with the U.S. Food and Drug Administration, Oxygen Biotherapeutics, Inc has announced that it will expand its clinical trial plan for its perfluorocarbon therapeutic oxygen carrier and liquid ventilation product called Oxycyte in the use of Traumatic Brain Injuries. Patient enrollment is anticipated to begin in the first quarter of 2009. The study will be conducted in the United States with and additional trial planned for Canada and possibly Switzerland. The clinical trial will ascertain the correct dose of Oxycyte to affect a better outcome for patients on the Extended Glasgow Outcome Scale (EGOS). The EGOS is a scale determining the level of disability a TBI patient has incurred. Both the U.S. and Canadian studies will be multi-center studies focusing on finding the lowest dose that reduces thrombocytopenia (having fewer than normal number of blood platelets per unit volume of blood associated with hemorrhaging) and still provide clinical benefit in traumatic brain injury. “This gives us a more efficient way to advance our clinical trials. It is extremely important to bring Oxycyte another step forward because we have a level of obligation to TBI patients and their families," said company chairman and CEO Chris J. Stern, DBA. "Right now there is no medical treatment for TBI patients and mortality is 20 - 25 per cent. Additionally, of those that survive, half are unable to return to the lives they had before their injury. The procedure in the dose escalation studies is designed to find the safest dose level of our drug and to bring it to market in due course. These dose escalation studies are the foundation to move to the next step of enrolling and treating TBI patients and showing what Oxycyte can do to help them recover and lead normal, productive lives.”
