"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. 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."
Phase IIa Oxycyte Trial in Patients with Traumatic Brain Injury
In this open label, Phase II proof-of-concept, eight-patient study conducted at Virginia Commonwealth University, Oxycyte was administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. The study protocol includes two groups. The first four study patients were stabilized with 50% oxygen for four hours before and 12 hours following Oxycyte administration. The remaining four study patients breathed 100% oxygen on the same schedule. Clinical data on brain oxygen and metabolite levels are compared in patients from both groups. The primary purpose of this study is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.
Due to a technical malfunction whereby a complete measurement of oxygen levels in the brain of one treated patient was not made, nine patients were treated during this study to meet the eight-patient enrollment goal. While survival was not a trial endpoint, seven patients in the trial survived their brain trauma. Neither of the two mortality cases was related to the safety of Oxycyte. One patient suffered massive injury and was not expected to survive. Another patient was withdrawn from the trial upon the voluntary decision to remove life-support.
About Synthetic Blood International
Synthetic Blood International is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development a blood substitute, a liquid ventilation product and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for perfluorocarbons, and medical and industrial applications for biosensors. Each of the product candidates is designed with ad vantages over currently marketed products in major markets including acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, please visit www.sybd.com.
Safe Harbor Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking information made on the Company's behalf. All statements, other than statements of historical facts which address the Company's expectations of sources of capital or which express the Company's expectation for the future with respect to financial performance or operating strategies, can be identified as forward-looking statements. Such statements made by the Company are based on knowledge of the environment in which it operates, but because of the factors previously listed, as well as other factors beyond the control of the Company, actual results may differ materially from the expectations expressed in the forward-looking statements.