Healthcare Industry News: BD
News Release - August 28, 2006
Patient Treatment Completed in Synthetic Blood Traumatic Brain Injury TrialOxycyte Administration Increases Brain Oxygen Tension in All Trial Patients
Announcement of Preliminary Analysis of Trial Data Expected in 4th Quarter
COSTA MESA, Calif.--(HSMN NewsFeed)--Aug. 28, 2006--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced the completion of treatment in the Company's Phase IIa open-label, proof-of-concept Oxycyte(TM) study in traumatic brain injury. Oxycyte administration increased oxygen tension over baseline in all eight evaluable trial patients. The Company expects to announce results of preliminary data analysis from this trial in the 4th quarter.
The primary purpose of the Phase IIa 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 from severe head injury. The safety of delivering Oxycyte via intravenous infusion is also being assessed.
Patients qualifying for Oxycyte treatment in this study suffered from severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. The first four study patients breathed 50% oxygen for four hours before and 12 hours following Oxycyte administration. The final five treated study patients were stabilized on 100% inspired 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. Due to a data monitoring malfunction in one treated patient, nine patients were treated during this study to provide the required eight-patient trial data.
"Early data indicating increased oxygen tension in the brain following Oxycyte administration suggests Oxycyte's ability to oxygenate tissues with narrow or occluded capillaries, such as those that occur in brain injury, and suggest Oxycyte's promise as a therapy in human severe traumatic brain injury," said Robert Nicora, Synthetic Blood President and CEO. "We look forward to reporting additional data from this proof-of-concept study that could provide the foundation for further clinical development of Oxycyte for this indication."
About Traumatic Brain Injury
A traumatic brain injury is caused by a blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain. Among the indications of severe traumatic brain injuries are extended periods of unconsciousness or amnesia after the injury. Approximately 1.4 million Americans each year sustain traumatic brain injury for which there is no direct therapy. 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. The Centers for Disease Control and Prevention (CDC) estimates that at least 5.3 million Americans, approximately 2% of the U.S. population, currently have a long-term or lifelong need for help to perform activities of daily living as a result of a traumatic brain injury with direct medical costs and indirect costs, such as lost productivity, totaling an estimated $60 billion in the U.S. in 2000.
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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