In the company’s news yesterday,
Oxygen Biotherapeutics Inc. announced what it refers to as a “fruitful and productive” scientific meeting with the U.S. Food and Drug Administration regarding the company’s Oxycyte in Traumatic Brain Injury (TBI) therapeutic oxygen carrier.
According to the press release, the meeting has led the company to the decision it will expand its research plan to include another dose escalation safety and efficacy study for Oxycyte in up to 40 more patients. Oxygen Biotherapeutics will commence patient enrollment in the first quarter of 2009 in the United States, followed by a second study in Canada, and the possibility of one in Switzerland.
“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.
The U.S. and Canadian studies will be conducted as multi-center studies to determine the lowest dose that is efficient in reducing thrombocytopenia without sacrificing clinical benefits in traumatic brain injury (TBI).
According to Stern, because of the lack of treatment available for those afflicted with TBI, patients are sometimes unable to lead “normal” lives after such brain injury. The company has confidence its studies will result in an advantage that will push Oxycyte through the development process while lowering development costs.
“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,” Stern stated. “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.”
Dr. Bruce Spiess, co-chair of the company’s Scientific Advisory Board and Virginia Commonwealth University professor of anesthesiology and emergency medicine, said the additional studies will not only benefit the company and patients with TBI, but science itself.
“Adding a basic research component to the clinical study to find the correlation between thrombocytopenia and platelets will be a major step in science. For over 30 years low platelet count has been observed, but not understood in terms of cause. The commitment by the company to provide in-depth science will allow for future safety and provide a basis for all other applications and potentially solve numerous unresolved problems in other drugs,” Dr. Spiess stated. “The knowledge gained also could be the platform for significant income. We will be the first company to seriously and rigorously apply this science. Furthermore, the importance of all this work in terms of military blast injury in treating our troops is immense. Knowing more of the science regarding thrombocytopenia can only improve their outcomes.”
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