NoBlood

Jan B. Wade · #1 (**permalink**) 04-18-2005, 05:48 AM

http://home.businesswire.com/portal/...68&newsLang=en

April 18, 2005 04:00 AM US Eastern Timezone

Patients Enrolled in Synthetic Blood International's Phase II Oxycyte Trial; Two Additional Clinical Sites Receive IRB Approval

COSTA MESA, Calif.--(BUSINESS WIRE)--April 18, 2005--Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that it has enrolled its first two patients in its 60-patient Phase II Oxycyte(TM) trial to prevent tissue hypoxia in hip revision surgery. The first patient is expected to receive Oxycyte today and a second patient is scheduled to be treated next week. The Company further announced that two hospitals in Durham, North Carolina have received Investigational Review Board (IRB) approval and will be open for patient enrollment for this trial later this month. Oxycyte is the Company's proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier.

"We are extremely pleased to begin treating patients in our Phase II trial as we believe that Oxycyte will prove efficacious in preventing surgical procedure-induced tissue hypoxia and the resulting postoperative complications," said Robert Nicora, Synthetic Blood president and CEO. "With the addition of these two Durham-based hospitals, we now have a total of four clinical sites participating in our Phase II trial and expect the University of South Florida's Tampa General Hospital to receive IRB approval in the coming weeks. As we continue to make clinical progress, we are confident of our ability to complete this current trial and initiate additional Phase II Oxycyte trials later this year."

Patients participating in this trial have previously been deemed eligible for treatment and will be administered Oxycyte in conjunction with scheduled hip revision surgery. As medical conditions are subject to change, there can be no assurance that a patient will be treated with Oxycyte until a final lab test and clinical check-up, performed immediately prior to the surgery, is conducted and reviewed.

Phase II Oxycyte Trials

Synthetic Blood is currently enrolling patients in a Phase II Oxycyte trial, which is the first in a series of planned Oxycyte Phase II trials that will focus on surgery and indications for therapeutic oxygen. In this trial, Oxycyte is being administered to hip revision surgery patients who experience mild to moderate blood loss during surgery. While blood transfusions typically are not administered during such procedures, the amount of blood lost may result in postoperative complications caused by tissue hypoxia. The safety and efficacy of Oxycyte used to prevent tissue hypoxia in these orthopedic surgical patients will be evaluated in this trial at up to six U.S. clinical sites. Of the 60 patients Synthetic Blood intends to enroll, one-half will be treated with Oxycyte and the other half will serve as a control group. The Company expects to complete this study and report its findings later this year. Based on the results from this trial the Company intends to initiate a larger Phase II trial in the same patient population.

Subsequent Phase II Oxycyte trials will involve the use of Oxycyte in coronary bypass and heart valve replacement surgery patients, surgical patients that require large blood transfusions, and other indications for oxygen therapy. Management is currently working with prominent researchers to develop protocols for these additional Oxycyte Phase II trials. Subject to the Company's ability to raise additional capital, these trials are expected to begin later this year.

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.