Oxygen Biotherapeutics Reports First Patient Enrolment In Oxycyte Trial

Oxygen Biotherapeutics (Oxygen) has reported the enrollment of first patient in the Phase II-b, dose escalation, clinical trial in Switzerland for use of Oxycyte emulsion in traumatic brain injury (TBI). Oxycyte is a perfluorocarbon (PFC) therapeutic oxygen carrier.

Reportedly, the 128 patient study is entitled, ‘Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury’ or ‘STOP TBI’. The study is being supervised by a contract research organization, PFC Pharma Focus.

The company also said that the dose escalation studies will focus on finding the lowest dose of Oxycyte that provides clinical benefit in traumatic brain injury while minimising adverse effects. Dose levels of Oxycyte will start at 1.0ml/kg body weight and escalate in steps to 2.0ml/kg, and 3.0ml/kg for subsequent patient cohorts.

Chris Stern, chairman and CEO of Oxygen, said: “This trial is of invaluable importance in improving the outcome of patients with severe TBI. We hope to finally prove that there is a safe and effective treatment for this devastating injury. I know that our shareholders have been wondering why it has taken so long to dose the first patient. It has taken longer than expected due to important training and logistical considerations at the trial sites.”