Healthcare Industry News: BD
News Release - July 12, 2006
Synthetic Blood Updates Traumatic Brain Injury Trial EnrollmentSix of Eight Patients Treated in Phase II Study
COSTA MESA, Calif.--(HSMN NewsFeed)--July 12, 2006--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced treatment of the fifth and sixth patients in its eight-patient Phase II proof-of-concept Oxycyte(TM) study in traumatic brain injury. Oxycyte administration significantly increased brain oxygen tension over baseline in these patients, which is consistent with the results in the first four patients.
The two newly treated study patients were stabilized with 100% oxygen for four hours before and 12 hours following Oxycyte administration. The first four study patients received 50% oxygen on the same schedule. Data on brain oxygen and metabolite levels will be compared in patients from both groups.
"In addition to seeing increased oxygen levels in the patients treated with Oxycyte, all six patients appear to be making good clinical progress with improved functional outcomes," said Robert W. Nicora, Synthetic Blood President and CEO. "We continue to be pleased with these clinical results. Based on historical enrollment trends, and subject to availability of capital, we expect to complete this trial and report final results before the end of the year."
In Synthetic Blood's open label, Phase II pilot study being conducted at Virginia Commonwealth University, Oxycyte is administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. 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.
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 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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