Positive Analysis from Synthetic Blood Oxycyte use in TBI
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 agreement 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. Patients in this trial were stabilized with either 50% or 100% oxygen. “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% or 50% 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.”
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