Healthcare Industry News: BD
News Release - December 22, 2006
Synthetic Blood Reports Positive Preliminary Results From Traumatic Brain Injury Clinical TrialData Show Oxycyte Improves Oxygen Tension and Metabolite Levels with Favorable Clinical Outcomes
COSTA MESA, Calif.--(HSMN NewsFeed)--Synthetic Blood International, Inc. (OTCBB:SYBD ) announces positive findings from a preliminary analysis of a Phase IIa clinical trial with Oxycyte(TM) in eight patients with traumatic brain injury. Data from this open-label, proof-of-concept, single-site study demonstrate that Oxycyte increases brain oxygen tension and glucose metabolism compared to baseline, and favorably affects other brain chemistries that impact clinical outcomes in patients with traumatic brain injury. This data was compiled and analyzed by Virginia Commonwealth University.
Due to a technical malfunction whereby a complete measurement of oxygen levels in the brain of one treated patient was not made, nine patients were treated during this study to meet the eight-patient enrollment goal. While survival was not a trial endpoint, seven patients in the trial survived their brain trauma. Neither of the two mortality cases was related to the safety of Oxycyte. One patient suffered massive injury and was not expected to survive. Another patient was withdrawn from the trial upon the voluntary decision to remove life-support.
M. Ross Bullock, M.D., Ph.D., Department of Neurosurgery, Medical College of Virginia, Virginia Commonwealth and the study's principal investigator, said, "We are encouraged to report that following administration of Oxycyte, we saw a survival rate in these patients that was far better than we had anticipated, as well as exceptional improvements in clinical outcomes especially given the severity of these cases that would typically constitute irreparable tissue damage. Each patient's oxygen level increased significantly, with some increasing three- to five-fold. To date all seven surviving patients are neurologically intact and have been discharged to their homes. This is extremely impressive as historical experience suggests that patients suffering from this level of traumatic brain injury have a 30% to 40% mortality rate and a 40% to 60% neurological deficit rate, and that an estimated 10% to 15% of patients require long-term care."
"Oxycyte continues to show great promise as a safe and effective therapeutic oxygen carrier," said Robert Nicora, Synthetic Blood President and CEO. "We are delighted with the findings of this preliminary analysis and Oxycyte's ability to increase brain oxygen tension more effectively than either 50% or 100% inspired oxygen, and we continue to believe that Oxycyte may be a valuable treatment for patients with traumatic brain injury."
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, please 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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