May 16, 2007 — Synthetic Blood International Inc. announced positive data from a statistical analysis of its Phase IIa study with Oxycyte in patients with traumatic brain injury. In line with preliminary study results announced in December 2006, statistical results confirmed that the primary endpoint of increasing patients' oxygen tension levels compared with baseline was met.
Data also show a decrease in patient glucose and lactate/pyruvate (LP) ratio, consistent with increased glucose metabolism. Patients in this trial were stabilized with either 50 percent or 100 percent oxygen. Data determined that results of both treatment arms were favorable, with statistically significant differences in some data between the two treatment arms.
"This analysis further validates our initial study findings that Oxycyte is more effective in increasing brain oxygen tension levels and impacting other brain chemistries that contribute to more favorable clinical outcomes in patients with traumatic brain injury, than breathing either 100 percent or 50 percent oxygen alone," said Robert Nicora, president and CEO. "Based on these positive results, we are working with Virginia Commonwealth University (VCU) to develop a protocol for a multicenter, controlled Phase IIb trial that could enroll up to 100 patients with traumatic brain injury. Researchers at VCU are drafting a manuscript with the Phase IIa TBI results to submit to a scientific journal.
"We continue active discussions with several sources for financing the company," Mr. Nicora continued. "If we are successful in these discussions, the receipt of additional funding will enable us to move forward with our Phase IIb program and other development activities with Oxycyte, which include plans to initiate a cardiac ischemia study in an animal model."
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June 06, 2023 
