Positive Statistical Analysis from Synthetic Blood's Oxycyte Traumatic Brain Injury Trial Indicates Achievement of Primary Endpoint.Oxycyte Increased Brain Oxygen Tension in Phase IIa Study COSTA MESA, Calif. -- Synthetic Blood International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :SYBD) today announced positive data from a statistical analysis of its Phase IIa study with Oxycyte[TM] in patients with traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain . 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 glucose metabolism, n the process by which simple sugars found in many foods are processed and used to produce energy in the form of ATP. Once consumed, glucose is absorbed by the intestines and into the blood. . Patients in this trial were stabilized with either 50% or 100% 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% or 50% oxygen alone," said Robert Nicora, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Based on these positive results, we are working with Virginia Commonwealth University Formed by a merger between the Richmond Professional Institute and the Medical College of Virginia in 1968, VCU has a medical school that is home to the nation's oldest organ transplant program. (VCU VCU Virginia Commonwealth University VCU Voiding Cystourethrogram VCU Video Control Unit VCU Vice City Unleashed (video game) VCU Value Compare Unit (Cisco) VCU Versatile Computer Unit ) 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 TBI 1. Thyroxine-binding index 2. Total body irradiation 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 Glas·gow Coma Scale n. A scale for measuring level of consciousness, especially after a head injury, in which scoring is determined by three factors: amount of eye opening, verbal responsiveness, and motor responsiveness. 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 metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. applications for perfluorocarbons, and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. , stroke, myocardial infarction myocardial infarction: see under infarction. , surgery, trauma, malignant tumors and diabetes. For further information, please visit www.sybd.com. Safe Harbor Statement The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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