Healthcare Industry News: BD
News Release - March 16, 2006
Synthetic Blood Enrolls First Patient in Phase II Traumatic Brain Injury StudyCOSTA MESA, Calif.--(HSMN NewsFeed)--March 16, 2006--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced that the first patient has been enrolled and treated in its eight-patient Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte(TM) in patients with traumatic brain injury. Oxycyte is Synthetic Blood's proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
"About 1.4 million Americans each year sustain traumatic brain injury and there is no direct therapy for this condition. Ischemic brain damage is found in 80% of patients who die of severe head injury and about one third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following injury. We are confident that Oxycyte will prove efficacious in its ability to unload oxygen more efficiently than blood," said Robert Nicora, Synthetic Blood President and CEO. "Recent study data suggest that Oxycyte improves cognitive recovery following traumatic brain injury in a fluid percussion injury model, a widely accepted rat model that simulates moderate head injury with prolonged cognitive deficits sustained in humans."
In this open label, Phase II pilot study being conducted at Virginia Commonwealth University, Oxycyte is being 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.
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.
Source: Synthetic Blood International
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