Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT), announced today that it is partnering with Pharmaceutical Product Development, LLC (PPD), a global contract research organization, to resume and complete OBI’s STOP-TBI ( S afety and T olerability of O xycyte in P atients with Severe non-Penetrating T raumatic B rain I njury) Phase II-b clinical trial.
“The development of Oxycyte® as a potential breakthrough therapy for severe traumatic brain injury remains the top priority of this company, and for the past 12 months we have remained committed to resuming enrollment in our clinical trials. Engaging a qualified CRO is a critical step in getting trial sites back up and running and open for enrollment by year-end,” said Michael Jebsen, President and Chief Financial Officer of OBI.
OBI completed the first cohort of a planned three cohort dose escalation study. Based on unblinded review of safety data from the 11 enrolled patients, the Data Safety Monitoring Board (DSMB) unanimously approved initiating Cohort 2. Cohorts 2 and 3 will enroll 18 subjects each with the DSMB reviewing safety data at the end of each cohort. An additional 50 patients with severe TBI will be treated at the highest dose approved by the DSMB. The company expects the trial to be completed in late 2015.
The primary objective of the trial is to 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 ameliorating the severity of TBI and represents an opportunity for the collection of placebo-controlled efficacy data, specifically, clinical and functional improvement. Functional status will be measured by the Glasgow Outcome Scale (GOS-E), a validated tool that helps to assess progress in patient recovery from their injury.