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 US Department of Defense to Ross Bullock, 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.
Chris Stern, chairman and CEO of Synthetic Blood International, said: “Assuming the FDA approves the protocol, our goal is to begin enrolling and treating traumatic brain injury patients this summer. 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.”