Synthetic Blood Announces Department of Defense Grant for Traumatic Brain Injury Clinical Trial with Oxycyte
COSTA MESA, Calif., Feb 26, 2008 (BUSINESS WIRE) -- Synthetic Blood International, Inc. (OTCBB: SYBD) today announced that The United States Department of Defense (DoD) has approved the award of a $1.9 million grant to M. Ross Bullock, M.D., Ph.D., of the University of Miami Miller School of Medicine, Department of Neurosurgery and principal investigator for the Company's planned Phase IIb clinical trial with Oxycyte(TM) for the treatment of traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
"With this grant, we will be able to double our planned enrollment in the Phase IIb trial to 200 TBI patients, providing a larger statistical basis for evaluating Oxycyte's effectiveness as a treatment in this indication," stated Dr Bullock, who was a principal investigator in Synthetic Blood's Phase IIa pilot study in TBI and currently serves as Co-Chairman of the Company's Scientific Advisory Board. "We are scheduled to commence the double-blind, placebo-controlled Phase IIb trial in April of this year."
"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 DoD, we may be able to accelerate Oxycyte's market approval," stated Robert Larsen, Interim President and CEO of Synthetic Blood. "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."
Positive data from the Oxycyte pilot study in TBI patients demonstrated that Oxycyte was more effective in increasing brain oxygen tension levels and impacting other brain chemistries that contribute to favorable clinical outcomes in TBI patients than breathing either 100 percent or 50 percent oxygen.
About 12,000 coalition troops have been injured in the global war on terror, and severe TBI has been termed "the signature injury" in this conflict, noting that TBI is often accompanied by multiple additional injuries as a result of improvised explosive devices (IEDs) or shrapnel. Importantly, TBI is the largest cause of death and severe disability among persons under the age of 40 in the U.S., as well as worldwide. Most TBI victims die or remain severely disabled due to inadequate early cerebral oxygenation or perfusion, which are always present around focal injuries.
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