Synthetic Blood International, Inc. Announces Plans to File Protocol for Phase II-b Oxycyte(R) Clinical Trial

COSTA MESA, Calif. - (Business Wire) Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that it intends to file a clinical protocol next week 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 plans to submit the Phase II-b protocol the week of April 7, 2008. The decision to file the protocol was made after the FDA accepted without comment the report on the results of the TBI Phase II-a safety study.

The company’s planned multi-center, double-bind, 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.

Source - The Earth Times

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