Synthetic announced yesterday that The United States Department of Defense approved the award of a $1.9 million grant to M. Ross Bullock, B.D., and Ph.D., of the University of Miami Miller School of Medicine, Department of Neurosurgery and principal investigator for the Company’s planned Phase llb clinical trial with Oxycyte™ for the treatment of traumatic brain injury. Oxycyte is the Synthetic Blood International’s perfluorocarbon therapeutic oxygen carrier and blood substitute.
Dr. Bullock, C0-Chairman of the Company’s Scientific Advisory Board noted, “With this grant, we will be able to double our planned enrollment in the Phase llb trial to 200 TBI patients, providing a larger statistical basis for evaluating Oxycyte’s effectiveness as a treatment in this indication. We are scheduled to commence the double-blind, placebo-controlled Phase llb trial in April of this year.”
Robert Larsen, Interim President and CEO of Synthetic Blood International, Inc. also notes, “If results from the Phase llb clinical trial in this larger patient population are similar to those of our small Phase lla pilot study, and with the support of the DoD, we may be able to accelerate Oxycyte’s market approval. If successful, this study should have a significant impact on arresting the advancement of brain damage in these patients and result in a one-shot emergency room treatment ha could be used for all brain –injured patients.”
TBI patients show positive data from the Oxycyte pilot study that it was more effective in increasing brain oxygen tension levels. TBI is the largest cause of death and severe disability among persons under the age of 40 in the U.S., as well as worldwide. Most TBI victims die or remain severely disabled due to inadequate early cerebral oxygenation or perfusion.
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