Oxygen Receives Approval To Begin Phase II Trial Of Oxycyte In Switzerland

Oxygen has received approval to begin a phase II, dose escalation, clinical trial in Switzerland for use of Oxycyte in traumatic brain injury (TBI).

The company has named the 128 patient study – Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury or STOP TBI. The first patient is expected to be enrolled in September.

Reportedly, the dose escalation studies will focus on finding the lowest dose of Oxycyte that provides clinical benefit in traumatic brain injury, while minimizing adverse effects.

Chris Stern, chairman and CEO of Oxygen, said: This approval from Swissmedic means that we can begin enrolling patients. Our people have worked very hard to achieve this major milestone for our company. 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.

We have a premier Contract Research Organisation (CRO) to manage the Swiss trials and what I consider to be some of the best neurosurgeons in Switzerland as clinical investigators along with leading Swiss hospitals as study sites. Because of the way we are structuring the trials and the quality of the Swiss medical community, we should have data compliant with the requirements of a multi-national study that can be submitted to the FDA as well as Swissmedic, he added.