Oxycyte® Trials in Switzerland
In this Blog I want to talk about our Swiss Oxycyte® Traumatic Brain Injury trials. Some readers may remember that our original plans in December 2007 were to conduct a multinational study in Europe as well as the USA. When we decided in October 2008 to conduct our phase II-b trial as a dose escalation study we initially felt it would be easier to do this in the U.S. alone. Switzerland has always been an option for trials and early this year it became evident that it was actually the better and faster way to get the data we need to move Oxycyte forward in severe TBI. So we redirected our resources and decided to move forward as aggressively as possible.
An article published in Swiss Med Weekly in 2008 discovered stunning data about the feasibility in cohort studies for severe TBI in Switzerland: The incidence of severe TBI is 8.2 per 100,00 person years. The overall case fatality is 70%: 41 of 101 persons died at the scene of accident. 23 of 60 hospitalized patients died within 48 hours, and 31 within six months. The conclusion was what we knew already: Severe TBI was associated with high case fatality and considerable morbidity in survivors. Our phase 2-a study data suggests that Oxycyte has the potential to reduce the morbidity of survivors significantly, maybe up to 50%. Every patient being better than he/she would have been without Oxycyte is a success for the survivors, their families, and the social network, or institution that finally has to carry the burden of responsibility to give these people a decent life.
The reason why we choose Switzerland for our trials is first and foremost the quality of medical research in there. The country is home to some of the largest pharmaceutical and biomedical companies in the world. Due to the high level of standard of care, the costs to enroll a patient to a study in Switzerland is only about 25% of what it is in the U.S. Also, the Swiss population lives a healthier lifestyle than the average American and thus complexity in selecting patients will be reduced.
The second reason is the regulatory process, which is more tailored to a sponsor’s needs. It is an overall reasonable approach managed by a two-tier regulatory body. The first tier is the cantonal (state) ethics committee of every canton where a trial is intended to take place. The advantage of these committees is that only doctors currently in active clinical duty staff them. The disadvantage is that, in our case, we have to go to up to five cantonal boards to get approval. However, once the first ethical committee has issued a positive review, the file is submitted to Swissmedic, the national regulatory body.
Swissmedic has set a benchmark in regulatory professionalism and are extremely well organized. They typically follow recommendations of the ethic committees. Data gathered in international trials is generally accepted by the FDA, if the protocol is adhered to.
The CRO we have hired is a company called PFC, which just by coincidence is the shorthand for Perfluocarbons. But despite the common acronym there is no relation. The principal investigator of our Swiss trials is Dr. Michael Reinert, a highly renowned and awarded neurosurgeon at the Insel Hospital of Berne. Dr. Reinert has been involved in the treatment of many local headline news cases. Our global primary investigator, Dr. Ross Bullock, has been working and publishing with Swiss colleagues for many years. Several of his recent publications include Swiss neurosurgeons as co-authors or contributors. An announcement about our final selection of trials sites will be made after the investigator meeting of March 31.
Following the investigator meeting we have scheduled an investor conference for April 1 from 1PM to 3PM CET (7AM to 9AM EDT) at the Zurich Airport Radisson SAS hotel. The event will be webcast live and include a short business update and sufficient time for an extensive question and answer part with Dr. Bullock, and Dr. Spiess.
Meanwhile, we continue to work with the FDA to conduct clinical trials in the USA. We are certainly being careful to follow procedures with the FDA by the book and I will not comment on my thoughts or express opinions on this. Many companies have hurt themselves by fighting the FDA via public opinion. That is why we are not going this route. The FDA Ombudsperson has received our rebuttal to conclusions that were presented to us and the review process is under way.
We know we have an indication with a favorable risk-benefit profile in a critically ill population for which there is currently no therapy available. TBI has a mortality and major morbidity rate of at least 50% and it remains the largest cause of death and disability in young persons under 40 worldwide. In an indication with significant mortality with no approved single drug intervention, our nine- patient feasibility study with Oxycyte in severe TBI showed evidence of biological efficacy and cerebral neurochemical improvement after the drug, with no patient suffering harm as a consequence of the drug. We are optimistic that we will end up with permission to begin our trials in this country. Be assured that we will keep you informed of the developments.