Oxygen Biotherapeutics, Inc. has partnered with PPD to conduct its Phase IIb trial, STOP-TBI (Safety and Tolerability of Oxycyte in Patients with Severe non-Penetrating Traumatic Brain Injury). The trial will evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury. The secondary objective is to assess the potential of Oxycyte in improving the severity of TBI.
Dr. Timothy Bradshaw, executive vice president of Drug Development at OBI, said, “We are pleased to be working with PPD as our CRO to oversee the completion of this critical trial. We selected PPD for their global reach and expertise conducting trials in which critically injured subjects are identified and managed in an emergency or trauma setting. They have presented a great operational plan for ensuring the successful completion of the study. In addition, PPD has medical staff with therapeutic expertise in neurotrauma. Our focus now is getting sites ready to enroll patients.”