Synthetic Blood to Accelerate Phase II Clinical Development of Oxycyte

Costa Mesa, CA - Synthetic Blood International, Inc. announced it plans to initiate Phase II trials with its proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier, Oxycyte(TM), in patients with traumatic brain injury and with sickle cell anemia. The Company expects to complete both clinical trials and report trial data before the end of 2005 subject to its ability to obtain additional financing.

The Company also announced that in an effort to advance Oxycyte through the clinical development process and secure Phase II data rapidly, it has temporarily suspended patient enrollment in its Phase II clinical trial in patients with hip revision surgery to allocate resources to the smaller, faster Phase II studies.

"Our objective to move Oxycyte toward market approval quickly and cost effectively is best served by actively moving forward with these smaller trials," said Robert Nicora, Synthetic Blood President and CEO. "While five highly reputable clinical sites are participating in our hip revision surgery trial, and patient recruitment has been proceeding, enrollment has been slower than we had anticipated. We have received interest in entering our hip revision trial from several additional sites, and look forward to a potential continuation of this trial at some point in the future with current and possibly new sites on board."

Synthetic Blood believes that recruitment in the eight-patient traumatic brain injury trial and the 20-patient sickle cell trial will be rapid, as both indications represent unmet medical needs with no available alternative therapies. The Company expects both trials to be conducted at Virginia Commonwealth University Hospital.

"We will enter these two clinical studies with added knowledge based on our experience to date in the hip revision surgery trial," added Mr. Nicora. "We are fortunate to have conducted additional trials in humans without any reports of adverse drug-related events, and we increased our exposure in the medical community as several surgeons have now used Oxycyte in a clinical setting."

About the Oxycyte Traumatic Brain Injury Trial
In August 2005 Synthetic Blood submitted an amendment to the Company's Oxycyte Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) 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 this eight-patient, open label, Phase II pilot study, Oxycyte will be administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9 within 24 hours of the injury's occurrence. 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. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion. The Company has already identified clinical sites for this trial and expects to initiate and report results from this study before the end of 2005.

About the Oxycyte Sickle Cell Anemia Trial
Synthetic Blood plans to file an amendment to its Oxycyte IND application with the FDA to initiate a Phase II pilot study in patients suffering from sickle cell anemia. Sickle cell anemia is a genetic condition that affects approximately 72,000 people in the United States. The Company has already identified clinical sites for this trial and expects to initiate and report results from this study before the end of 2005.

SOURCE: Synthetic Blood International