Synthetic Blood International Announces Preparations for Phase II Oxycyte Clinical Testing
COSTA MESA, Calif.--(BUSINESS WIRE)--Jan. 7, 2004--Synthetic Blood International Inc. (OTCBB: SYBD) announced today that Phase II clinical testing of Oxycyte(TM), the company's perfluorocarbon (PFC) based blood substitute and therapeutic oxygen carrier, is on schedule to begin during the first quarter of 2004. The company believes that Oxycyte may be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation.
At the same time, SYBD is preparing for preclinical animal studies of Oxycyte for newly identified applications in cardiac surgery. These studies at two east coast universities will address the possible risk of untoward neurological effects with Oxycyte in cardiac bypass surgery. Last month, the company announced that it is developing a new cardiac surgery application strategy for Oxycyte.
These preclinical animal studies apply only to cardiac surgery applications of Oxycyte and are required by the U.S. Food and Drug Administration.
"These animal studies will pave the way for Phase II testing of Oxycyte in bypass patients, which is an exciting potential application for Oxycyte," said Robert Nicora, SYBD president.
While the company has sufficient capital to complete the Phase I study as well as at least two Phase II studies, the company cautions that there can be no guarantees regarding its ability to raise additional capital, or to predict the outcome of clinical trials.
In addition to Oxycyte, SYBD is developing Fluorovent(TM), a liquid ventilation product that may be useful in treating respiratory disorders in adults and children. The company is also developing an implantable glucose biosensor for the continuous monitoring of blood glucose levels in diabetics.
The company is traded under the symbol SYBD on the OTC Electronic Bulletin Board. SYBD has headquarters in Costa Mesa, Calif. The company's Web site is www.sybd.com.
Except for historical information, the matters set forth in this release are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein. This includes the availability of funding for further testing and development, uncertainties associated with the conduct of pre-clinical or clinical studies and the timing or ability to investigate scientific data. SYBD refers you to cautionary and other information contained in recent Form 10-Q and 10-K documents filed with the SEC.