MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc. (OBI) (OXBT), today announced the initiation of the second cohort of its Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury (STOP-TBI). The second cohort begins officially with the activation of the first of five planned sites in Israel. This trial site will receive its first shipment of Oxycyte this week and can immediately begin enrollment. Resuming enrollment in the second cohort of our TBI trial is a critical milestone in the development of Oxycyte, said Michael Jebsen, President and Chief Financial Officer of OBI. We have spent the last year focused on securing long-term supply of clinical trial material and retaining a contract research organization with the ability to effectively manage an international clinical trial. Bringing Oxycyte to market as a treatment for acute ischemic conditions, such as TBI, remains the top priority of OBI. The STOP-TBI trial is a randomized, double-blind, placebo-controlled dose-escalation study in which a single intravenous administration of Oxycyte is given to patients in conjunction with supplemental oxygen. The primary objective of the trial is to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating … Continue reading
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