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news.Oxygen Biotherapeutics, a biotechnology company, has hired PFC Pharma Focus, a Swiss contract research organization to supervise the planned Phase II, dose escalation, clinical trial in Switzerland for use of Oxycyte in traumatic brain injury.
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The company has initiated the filing process for their protocol in Switzerland with the relevant cantonal ethic committees and Swissmedic, the Swiss counterpart to the US FDA. This is the process for submission in Switzerland. The protocol is the same as the one the company plans to submit to the FDA.
Principal investigator will be Michael Reinert, managing director of the University Hospital of Berne. Trial sites and further trial details will be announced after they are finalized.
Chris Stern, chairman and CEO of Oxygen Biotherapeutics, said: “We have lined up a premier contract research organization to manage the Swiss trials. What’s exciting is that we have interest from what I consider to be some of the best neurosurgeons in Switzerland who want to be clinical investigators in these trials and from leading Swiss hospitals interested in being study sites.”