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Tampa General Hospital Approved to Enroll Patients in Synthetic Blood International's Phase II Oxycyte Trial

Posted on: Monday, 25 July 2005, 06:00 CDT

Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that the University of South Florida's Tampa General Hospital is the fifth clinical site to receive Investigational Review Board (IRB) approval to enroll patients in Synthetic Blood's 60-patient Phase II Oxycyte(TM) trial. Oxycyte, the Company's proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier, is being administered to hip revision surgery patients who experience mild to moderate blood loss during surgery. The Company expects to complete enrollment and to present preliminary trial data by the end of 2005.

"We are extremely pleased that Tampa General has come on board, and we expect that pooling from this hospital's large population of hip replacement patients will prove a great asset in advancing trial enrollment," said Robert Nicora, Synthetic Blood president and CEO. "Oxycyte has demonstrated a superior safety profile compared with other blood substitutes being evaluated for use in similar and other medical situations. With no significant adverse effects reported to date, we are confident in our product's advantages."

Phase II Oxycyte Trials

Synthetic Blood's Phase II Oxycyte trial in hip revision surgery patients is the first in a series of planned Oxycyte Phase II trials that will focus on surgery and indications for therapeutic oxygen. While blood transfusions typically are not administered during this procedure, 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 patients Synthetic Blood intends to enroll, one-half will be treated with Oxycyte and the other half will serve as a control group. 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.

Source: Business Wire

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