Synthetic Blood International, Inc. Announces Filing of Protocol for Phase II-b Oxycyte Clinical Trial
COSTA MESA, Calif. — April 14, 2008 — Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that it has filed a clinical protocol with the U.S. Food & Drug Administration (FDA) for its planned Phase II-b clinical trial of Oxycyte® in Traumatic Brain Injury (TBI) patients. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
The company’s planned multi-center, double-blind, placebo-controlled study would enroll up to 300 patients. 200 patients will be allowed for enrollment through a recently approved $1.9 million grant from the United States Department of Defense to M. Ross Bullock, M.D., Ph.D., of the University of Miami Miller School of Medicine, Department of Neurosurgery. Dr. Bullock is the principal investigator for the planned Phase II-b clinical trial. The company plans to do an interim analysis after enrolling 100 patients and then may elect to enroll up to 300.
“Assuming the FDA approves the protocol, our goal is to begin enrolling and treating TBI patients this summer,” said company chairman and CEO Chris J. Stern, DBA. “Everyone has worked so hard in getting this protocol done. It is even more exiting that part of this study will be financed by a Department of Defense grant. One of our researchers always says, ‘Oxycyte will bring patients with TBI back to the taxpayer base.’ We hope to help save as many patients as we possibly can from ending up in a severe state just because they lacked oxygen in tissue after an injury.” |
