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COSTA MESA, Calif., March 3 (UPI) -- The U.S. Department of Defense announced it has approved a grant for California-based Synthetic Blood International Inc.'s clinical trial with Oxycyte.
Company officials say the $1.9 million grant was awarded to M. Ross Bullock, Synthetic Blood scientific advisory board co-chairman and principal investigator for the phase IIb clinical trial with traumatic brain injury treatment Oxycyte.
"With this grant, we will be able to double our planned enrollment in the phase IIb trial to 200 traumatic brain injury patients, providing a larger statistical basis for evaluating Oxycyte's effectiveness as a treatment in this indication," Bullock said in a statement. "We are scheduled to commence the double-blind, placebo-controlled Phase IIb trial in April of this year."
The development of Oxycyte, a perfluorocarbon therapeutic oxygen carrier and blood substitute, is an effort by the Defense Department to address the needs of the estimated 12,000 coalition troops that have suffered traumatic brain injury in the global war on terror. Many consider traumatic brain injury the signature injury in the Iraqi and Afghanistan military theaters as a result of extensive use of improvised explosive devices by terrorists.
"If results from the phase IIb clinical trial in this larger patient population are similar to those of our small phase IIa pilot study, and with the support of the Department of Defense, we may be able to accelerate Oxycyte's market approval," said Robert Larsen, Synthetic Blood interim president and chief executive officer. "If successful, this study should have a significant impact on arresting the advancement of brain damage in these patients and result in a one-shot emergency room treatment that could be used for all brain-injured patients."
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