Synthetic Blood to Initiate Oxycyte Phase II Pilot Study in Traumatic Brain Injury
Synthetic Blood International, Inc. (OTCBB: SYBD) today announced that is has submitted an amendment to the Company’s Oxycyte Investigational New Drug (IND) application to initiate a Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte(TM) in patients with traumatic brain injury. The Company expects to report results from this study before the end of 2005. Oxycyte is Synthetic Blood’s proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier.
Ross Bullock, MD, Ph.D., chief of neurotrauma and neurocritical care, at Virginia Commonwealth University and the study’s principle investigator, said, “Currently ischemic brain damage is found in 80% of patients who die of severe head injury. Approximately one third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following injury, which can lead to post-traumatic brain damage. Oxycyte presents a particularly attractive candidate for increasing cerebral oxygen delivery as earlier studies have demonstrated its potential to perfuse and oxygenate tissues in brain contusions, where capillaries are so narrow that red blood cell transport is impeded.”
“This pilot study represents just one of the many potential applications for Oxycyte and signifies our continued progress in moving Oxycyte through the clinical process,” said Robert Nicora, Synthetic Blood President and CEO. “We are confident that Oxycyte will continue to exhibit a superior safety profile, and prove efficacious in its ability to unload oxygen more efficiently than blood. We also plan to clinically test Oxycyte as a first line therapy in other ischemic conditions such as heart attacks.”
In this eight-patient, open label, Phase II pilot study, Oxycyte will be administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9 within 24 hours of the injury’s occurrence. The primary purpose of this study will be 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.
Synthetic Blood is also currently conducting a Phase II study to determine the safety and efficacy of Oxycyte in preventing tissue hypoxia in orthopedic surgical patients (hip surgery). While blood transfusions are not typically administered during this procedure, the amount of blood lost may result in postoperative complications caused by tissue hypoxia. The Company expects to complete this trial and report data by the end of 2005.
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 and 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 advantages over currently marketed products in major markets including acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, 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.