Oxygen Biotherapeutics (OBI) has announced the commencement of patient enrolment in the second cohort of its Phase IIb trial of Oxycyte in Israel.
The Phase IIb clinical trial will investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury (STOP-TBI).
OBI president and chief financial officer Michael Jebsen said enrolment in the second cohort is a major milestone in Oxycyte’s development.
"We have spent the last year focused on securing long-term supply of clinical trial material and retaining a contract research organisation with the ability to effectively manage an international clinical trial," Jebsen said.
"Bringing Oxycyte to market as a treatment for acute ischemic conditions, such as TBI, remains the top priority of OBI."
The randomised, double-blind study administers oxycyte once intravenously to patients, along with supplemental oxygen.
The primary objective of the placebo-controlled dose-escalation study is to assess the safety and tolerability 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.
The Glasgow Outcome Scale – Extended (GOS-E) will measure the functional status of patients.
The STOP-TBI study will enrol an additional 68 subjects at up to 18 sites in Israel, Switzerland, France and Spain.