Synthetic Blood International Announces Preliminary Analysis of Oxycyte Phase I Study Results
COSTA MESA, Calif.--(BUSINESS WIRE)--Jan. 27, 2004--Synthetic Blood International Inc. (OTCBB: SYBD), announced today that a preliminary analysis of results from the completed Oxycyte Phase I clinical trial has been completed. Oxycyte is a perfluorocarbon (PFC) based blood substitute and therapeutic oxygen carrier under development by the company. In line with previous announcements, the completed results show an excellent safety profile.
The principal adverse reactions that have been seen with PFC based blood substitutes as a drug class are flu-like symptoms. Minor, transient symptoms were seen in some but not all Oxycyte subjects. However, these were less frequent and severe than those reported in Phase I clinical trials with two competing PFC blood substitutes.
When a full statistical analysis of the Phase I study results has been completed, a study report will be submitted to the Food and Drug Administration (FDA). This is expected to occur in the next few weeks. That submission will also describe preliminary Phase II clinical trial plans. SYBD is working with two eastern universities that have participated in PFC blood substitute clinical trials in developing these plans.
"We are very pleased with the outcome of the Phase I study," said Robert Nicora, SYBD president. "The PFC in Oxycyte was selected in part because of a superior safety profile in screening animal studies, when compared to competing PFCs, and it appears this product advantage will be confirmed by clinical trial results."
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 is headquartered 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.