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Synthetic Blood Announces Positive Results From Traumatic Brain Injury Preclinical Study

Posted on: Monday, 24 October 2005, 06:00 CDT

Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that study data suggest that its proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier Oxycyte(TM) 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. Cognitive recovery was determined by performance in a standard water maze test. As announced previously, Synthetic Blood plans to initiate a Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury.

In the study "Perfluorocarbon Emulsion Improves Cognitive Recovery Following Lateral Fluid Percussion Brain Injury in Rats," rats administered Oxycyte at 4.5ml/kg and 9.0ml/kg dose levels showed significantly better performance in the water maze test and had fewer dying neurons in the brain than control animals treated with a saline solution. Additionally, the group receiving Oxycyte at the higher dose maintained mean arterial blood pressure at a relatively higher level, which could indicate a further improvement in the cerebral blood flow after traumatic brain injury.

"We proved our study hypothesis that the PFC emulsion Oxycyte would increase the solubility of oxygen in the blood and thus improve oxygen delivery to the acutely injured brain following traumatic brain injury," said Ross Bullock, M.D., Ph.D., Department of Neurosurgery at Virginia Commonwealth University School of Medicine and co-author of the study. "Taken together, the results of this study suggest that Oxycyte may represent an extremely promising avenue for future therapy in human severe traumatic brain injury."

"Results of this study support our efforts to proceed with clinical development of Oyxcyte for this indication," said Robert Nicora, Synthetic Blood President and CEO. "Oxycyte has already proven safe in human clinical trials and, as a PFC emulsion with an extremely small average droplet size, it may be able to oxygenate tissues with narrow or occluded capillaries, such as those that occur in brain injury."

The Company indicated that the eight-patient, open label Phase II proof-of-concept trial in traumatic brain injury will be conducted at the Virginia Commonwealth University Medical Center. 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. If the results are positive, the Company plans to start a larger Phase II trial, subject to the availability of additional financing, that will look at clinical outcome as well as biochemical changes in the brain.

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: Business Wire

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