"Because the recently announced new financing raised more money than expected, we will be able to start more Phase II trials this year than originally planned," said Robert Nicora, SYBD president. "We are finalizing the first Phase II protocol and are planning to conduct three different trials, each looking at different applications for Oxycyte in surgery patients."
In the first Phase II trial, Oxycyte will be tested in orthopedic surgery patients who lose modest amounts of blood during surgery. While this amount of blood loss may result in post-operative complications caused by tissue hypoxia, blood transfusions are usually not required. This study will focus on using Oxycyte to prevent tissue hypoxia.
In another Phase II study, Oxycyte will be given to patients undergoing coronary bypass or heart valve replacement surgery on a heart-lung machine. Adverse neurologic effects, including stroke and cognitive impairment, occur post-operatively in 30% to 40% of these patients, caused in part by gaseous micro-bubbles produced by the heart-lung machine. This study will use Oxycyte to reduce the amount of micro-bubbles.
A third Phase II study will be conducted in surgical patients who lose enough blood during surgery to require a blood or red cell transfusion. Studies have shown that as the amount of blood or red cells transfused in these patients increases, the rate of post-operative infection, major organ failure and mortality increases. Additionally, the average age of transfused red cells used in elective surgery is three weeks, by which time oxygen delivery to tissues is seriously impaired. This study will try to show that Oxycyte is a safer and more effective way to restore oxygen delivery in these patients.
"In all of these studies, we will also evaluate Oxycyte clinical criteria thereby removing the regulatory obstacle created by the Food and Drug Administration, which regards blood replacement as merely a surrogate marker," Nicora said.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
The company is traded under the symbol SYBD on the OTC Electronic Bulletin Board. SYBD is headquartered in Costa Mesa. The Company's Web site is 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: Synthetic Blood International
CONTACT: Synthetic Blood International Inc.
Joan Mahan, 714-427-6363 or 800-809-6054
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In my opinion, this stock has HUGE potential. If they secure all the funds they need to finish the clinical trials of this synthetic blood product, Oxycyte, which will be in HUGE demand, they will easily be able to secure the funds they need (through profits and private placements) to complete clinical trials for their other 2 very promising products (Fluorovent and the implanted glucose biosensor).
www.sybd.com