MORRISVILLE, N.C.—OxygenBiotherapeutics Inc. recently announced that it has tapped PharmaceuticalProduct Development LLC (PPD), a global contract research organization, toresume and complete OBI's STOP-TBI (Safety and Tolerability of Oxycyte inPatients with Severe non-Penetrating Traumatic Brain Injury) Phase II-bclinical trial.
"The development of Oxycyte as a potential breakthroughtherapy for severe traumatic brain injury remains the top priority of thiscompany, and for the past 12 months, we have remained committed to resumingenrollment in our clinical trials. Engaging a qualified CRO is a critical stepin getting trial sites back up and running and open for enrollment byyear-end," said Michael Jebsen, president and chief financial officer of OBI.
OBI completed the first cohort of a planned three-cohortdose-escalation study. Based on unblinded review of safety data from the 11enrolled patients, the Data Safety Monitoring Board (DSMB) unanimously approvedinitiating Cohort 2. Cohorts 2 and 3 will enroll 18 subjects each with the DSMBreviewing safety data at the end of each cohort. An additional 50 patients withsevere TBI will be treated at the highest dose approved by the DSMB. Thecompany expects the trial to be completed in late 2015.
The primary objective of the trial is to evaluate the safetyand tolerability of a single administration of Oxycyte in patients with severenon-penetrating traumatic brain injury. The secondary objective is to assessthe potential of Oxycyte in ameliorating the severity of TBI and represents anopportunity for the collection of placebo-controlled efficacy data,specifically, clinical and functional improvement. Functional status will bemeasured by the Glasgow Outcome Scale (GOS-E), a validated tool that helps toassess progress in patient recovery from their injury.
"We are pleased to be working with PPD as our CRO to overseethe completion of this critical trial," said Dr. Timothy Bradshaw, executivevice president of drug development at OBI. "We selected PPD for their globalreach and expertise conducting trials in which critically injured subjects areidentified and managed in an emergency or trauma setting. They have presented agreat operational plan for ensuring the successful completion of the study. Inaddition, PPD has medical staff with therapeutic expertise in neurotrauma. Ourfocus now is getting sites ready to enroll patients."