The company reported today the enrollment of the first patient in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury. The first patient was enrolled at Israel’s Rambam Health Care Campus. This neurotrauma center treats approximately 200 severe brain injuries annually.
The trial is a randomized, double-blind, placebo-controlled, dose-escalation study of Oxycyte. The goal of the study is to evaluate the safety and tolerability of Oxycyte in traumatic brain injury patients. The secondary objective is to assess the potential of Oxycyte in ameliorating the severity of traumatic brain injury. Functional status of the patients will be measured by the Glasgow Outcome Scale – Extended (GOS-E), a validated tool that aids in assessing progress in patients with traumatic brain injury.
The first of the three cohort study ended with an independent safety monitoring board giving an unanimous recommendation of advancement to the second cohort. In addition to the five study centers receiving ethics committee approval in Israel, the study is expected to include sites in Switzerland, Spain, and France as well as other countries to be named later by Oxygen Biotherapeutics.
For additional information about Oxygen Biotherapeutics and its Oxycyte therapeutic oxygen carrier, please visit www.oxybiomed.com
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