Makers of Oxygen Carrier Meets with FDA for TBI Clinical Trial
During the week of October 20 the U.S. Food and Drug Administration will meet with the biomedical company Oxygen Biotherapeutics, Inc. to discuss any remaining issues the agency might have with their therapeutic oxygen carrier, Oxycyte®. Oxygen Biotherapeutics proposes to continue use of Oxycyte in a Phase IIb clinical trail in Traumatic Brain Injury. “At that meeting, we will be extensively prepared to resolve any remaining issues and concerns the FDA may have,” said company chairman and CEO Chris J. Stern, DBA. “We view this as a positive development, as the agency has also offered to review the Company's overall development plan. This may contribute to reducing regulatory risk at future stages such as Phase III. We will constructively use the dialog and its documentation process to align the clinical and non-clinical development plan for TBI with potential endpoints for Phase III and towards an eventual registration.” 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 $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 IIb clinical trial. The clinical trial date will depend on the outcome of the FDA review process.
