Oxygen Biotherapeutics Inc. has decided to stop a phase IIb trial of Oxycyte for traumatic brain injury after difficulty recruiting patients made it clear the company wouldn't be able to complete the program as soon as it had hoped. Oxygen CEO Johen Kelley said he'll discuss the program's future with existing partners and continue to advance a phase III trial of levosimendan, an FDA fast-tracked therapy for patients at risk for developing low cardiac output syndrome (LCOS).
The Oxycyte study was evaluating the safety and tolerability of the drug, a perfluorocarbon therapeutic oxygen carrier, in patients with severe nonpenetrating traumatic brain injury.
"It's a business decision," Kelley told BioWorld Today. "We took our time to evaluate what else we could do and what other avenues we could employ. At the end of the day, in presenting the data to the board [Thursday], we unanimously agreed that it's best to stop the trial because we