Healthcare Industry News: BD
News Release - August 9, 2006
Two Additional Traumatic Brain Injury Patients Treated in Synthetic Blood TrialCOSTA MESA, Calif.--(HSMN NewsFeed)--Aug. 9, 2006--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced treatment of the seventh and eighth patients in its Phase IIa proof-of-concept Oxycyte(TM) study in traumatic brain injury. Consistent with the results in previous patients treated in this trial, Oxycyte administration in the two most recently treated patients significantly increased brain oxygen tension over baseline.
Due to a data monitoring malfunction in a previously treated patient, a ninth patient will be enrolled and treated in the Phase IIa study to provide the required eight-patient trial data. Synthetic Blood expects to complete and report data from this trial before the end of the year.
M. Ross Bullock, MD, Ph.D., Department of Neurosurgery, Medical College of Virginia, Virginia Commonwealth and the study's principal investigator, said, "Approximately one-third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following traumatic brain injury, and this may be predictive of poor clinical outcome. In this trial Oxycyte is demonstrating the ability to increase brain oxygen tension more effectively than either 50% or 100% inspired oxygen, thus improving oxygen delivery to the acutely injured brain and brain metabolism following traumatic brain injury."
"Currently, there is no direct therapy for the 1.4 million Americans each year who sustain traumatic brain injury," said Robert Nicora, Synthetic Blood President and CEO. "The results of this trial are exciting because previous studies have shown that increasing brain oxygen levels in patients with severe brain injury is associated with a better clinical outcome relative to cognitive and motor function. We believe the positive study data to date provides a significant basis for initiating a Phase IIb Oxycyte trial in a larger traumatic brain injury patient population."
The two newly treated study patients were stabilized on 100% inspired oxygen for four hours before and 12 hours following Oxycyte administration. The final patient will also breathe 100% oxygen. The first four study patients breathed 50% oxygen on the same schedule. Data on brain oxygen and metabolite levels will be compared to baseline before Oxycyte administration in patients from both groups.
Synthetic Blood's open label, Phase II pilot study is 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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