NoBlood

Jan B. Wade · #1 (**permalink**) 11-19-2003, 08:25 AM

November 18, 2003 09:04 AM US Eastern Timezone
Synthetic Blood International Announces Completion of Second Dose Level in Phase II Clinical Study

BIOWIRE2K

COSTA MESA, Calif.--(BUSINESS WIRE)--Nov. 18, 2003--Synthetic Blood International Inc. (OTCBB:SYBD) announced today the successful completion of the second of three dose levels in a Phase I clinical safety study of Oxycyte(TM), the company's perfluorocarbon-based (PFC) blood substitute and therapeutic oxygen carrier. Nine subjects were given infusions of either Oxycyte or a control solution, in a double blind study design, and evaluated for adverse events. The only product related reactions were minor, transient increases in liver enzymes and decreases in platelet levels. There is no clinical significance to these changes.

"At this dose level, Oxycyte proved to be very well tolerated," said Robert Nicora, SYBD president. "The reactions that were seen were completely expected, based on preclinical animal safety studies with Oxycyte, and published clinical safety studies with competitive PFC products."

The third and final dose level in this study will start in early December, and the study will be completed by the end of the year. If favorable, the results of the Phase I study will provide the basis for testing Oxycyte in Phase II clinical studies in patients. The company anticipates Phase II studies will start in early 2004.

"We continue to be pleased with the results of this first clinical study with Oxycyte," said Nicora. "When all the results are in, we believe the safety profile of Oxycyte will be at least as good and may prove to be superior when compared with other PFC blood substitutes that have been clinically tested."

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 also 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. The company's Web site is www.sybd.com and e-mail address is info@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.