Synthetic Blood International Initiates First Phase II Oxycyte Trial
COSTA MESA, CA -- Jan. 6, 2005 -- Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that it has opened patient enrollment in its first Phase II Oxycyte(TM) clinical trial. Oxycyte is the Company’s proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier.
“We are extremely pleased to open the first of three initial clinical sites planned for our Phase II Oxycyte trial at a highly regarded State University of New York Medical Center,” said Robert Nicora, Synthetic Blood president and CEO. "Two other top ranked sites in Durham, N.C. are in the process of obtaining approval from their Institutional Review Boards to open enrollment. To accelerate enrollment, we plan to add an additional three study sites.
“With the completion of a new financing last quarter, we now have the financial resources to complete this trial,” added Mr. Nicora. “We continue to seek additional funds and are in active discussions with new institutional sources of small cap financing.”
In this Phase II study, the first in a series of planned Oxycyte Phase II studies that will focus on surgery, trauma and indications for therapeutic oxygen, Oxycyte will be administered to hip surgery patients who experience mild to moderate blood loss during surgery. While blood transfusions typically are not required 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. Subsequent Phase II Oxycyte trials will involve the use of Oxycyte in coronary bypass and/or heart valve placement surgery patients, and surgical patients that require blood transfusions. Management is currently developing protocols for these additional Oxycyte Phase II trials, which are expected to start later this year.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
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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- Synthetic Blood International, Inc.
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