NoBlood

Nika · #1 (**permalink**) 05-08-2005, 10:53 PM

Source:
Businesswire

Link:
www.businesswire.com

COSTA MESA, Calif. -- Synthetic Blood International, Inc. (OTCBB:SYBD) today announced Richmond-based Virginia Commonwealth University Medical Center (VCU), received approval from its Investigational Review Board (IRB) to open patient enrollment for Synthetic Blood's Phase II Oxycyte(TM) trial. Oxycyte is the Company's proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier.

"We are delighted to be working with a prestigious institution such as VCU on our current Phase II Oxycyte trial," said Robert Nicora, Synthetic Blood president and CEO. "We have now opened two clinical sites where patients are actively being screened for enrollment."

Additional sites are being reviewed for IRB approval, including two sites in Durham, North Carolina, and the University of South Florida's Tampa General Hospital, which conducts a large volume of hip replacement surgeries. The Company expects that pooling from this large patient population will prove a great asset in advancing patient enrollment in its Phase II trial.

"We continue to explore the opportunity for Oxycyte to become a safe and effective alternative to transfused blood and other indications," continued Mr. Nicora. "In addition to Oxycyte's potential ability to address many of the shortcomings of donor blood including supply shortages, disease transmission, the need for typing and crossing matching, inability to permeate small blood vessels, inefficient oxygen transmission after storage, and a short shelf-life, we also see other potential applications for Oxycxte in stroke, myocardial infarction and certain malignant diseases."

Phase II Oxycyte Trials

This current Phase II trial is the first in a series of planned Oxycyte Phase II studies that will focus on surgery and indications for therapeutic oxygen. In this study, Oxycyte will be 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. Synthetic Blood intends to enroll 60 patients, one-half of who 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, and initiate a larger Phase II study 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, traumatic brain injuries, sickle cell disease, and decompression sickness. Management is currently working together 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.

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NoBlood

Synthetic Blood Opens Clinical Site for Phase II Oxycyte Trial at Virginia Commonweal