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news.Synthetic Blood International has announced that the US Department of Defense or DoD has approved the award of a $1.9 million grant to Ross Bullock, principal investigator for the company's planned Phase IIb clinical trial with Oxycyte for the treatment of traumatic brain injury or TBI.
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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% or 50% oxygen. Oxycyte is the company’s perfluorocarbon therapeutic oxygen carrier and blood substitute.
Ross Bullock, co-chairman of the company’s scientific advisory board, said: “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. We are scheduled to commence the double-blind, placebo-controlled Phase IIb trial in April 2008.”