Although Swiss trials had always been planned, Oxygen has made them more of a focus since the US Food and Drug Administration (FDA) halted the Oxycyte Phase II programme last year.
Oxygen and PFC collaborated on protocol development for the Swiss dose-escalation trial, devising a methodology that has been submitted to the country’s drug regulators Swissmedic.
The trial will be run by Michael Reinert at the University Hospital of Berne, with additional details and trial sites being announced in due course.
Oxygen CEO Chris Stern announced the PFC deal and explained that the firm had received interest from “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.
“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 that the firm plans to begin patient enrollment sometime in the second quarter, depending upon approval by Swissmedic and went on to say that the firm is pushing forward with “Oxycyte Phase II plans without waiting for the FDA.”
Volketswil-based contract research organisation (CRO) PFC offers pharmaceuticals firms a range of clinical research and development services, including initial protocol development and data and trial site management.