Invest in ME blog post, 11 Feb 2018: Statement following preliminary Phase III Rituximab clinical trial results from Norway
Following the preliminary results which Professor Olav Mella recently publicly released from the Phase III multi-centre double-blinded placebo-controlled Rituximab Clinical Trial (see statement 21st November 2017) the charity has had discussions with advisors and researchers and has now received further communication from Dr Fluge in Norway.
Invest in ME Research has issued the statement below regarding the planned UK trial. The Haukeland team will be presenting at the IIMEC13 13th International ME Conference in London on 1st June 2018.
Since 2013, the charity has been funding and facilitating a project to perform a clinical trial of rituximab for ME. The trial was eventually being set up in the Norwich Research Park where the charity’s proposal for a Centre of Excellence for ME is being developed.
Cooperation was established with the Norwegian team at Haukeland University Hospital,
where a Phase III multi-centre clinical trial was being performed, and the charity had been arranging another visit to Norwich by the Norwegian team once they had broken the clinical trial codes, which finally occurred in the autumn of 2017. In November 2017, in a surprise development, the Norwegian team issued a preliminary assessment from the trial that had proven to be negative. We had no warning of these results prior to receiving the news. This news forced the charity to reconsider the planned UK trial.
After discussions with the charity’s advisors and researchers and the Norwegian team the charity has been advised that the UK trial of rituximab for ME is no longer practical or even possible to perform with the current state of knowledge following the preliminary results from the Phase III trial.
Future Research Pathway
When the charity announced the UK trial and it’s plans to fund it then it was stated from the outset that any funds raised would go to other biomedical research if the trial could not be performed. The charity has several times kept the trial on track after suffering some setbacks. We have done more than many others would have done in such a position.
The charity’s advisors and the researchers and consultant involved and the Norwegian team have now made it clear that it would not be advisable or possible to perform a UK rituximab trial, in light of the Norwegian Phase III trial results. Therefore, the charity will discuss with the Hendrie Foundation, who have made a large pledge toward the trial. We
will then come to a decision on what biomedical research will be funded with whatever remains from the rituximab trial fund. We share the disappointment that all our supporters will have following the Norwegian results.
The supporters of IiMER have been amazing. They have managed to help IiMER create a huge leap in awareness of ME – from being able to fund a trial, to create collaborations with researchers in Norway, and mainstream ME research. The charity and our supporters created something out of nothing. When others were merely talking about possibilities
IiMER and supporters acted.
It is to our supporters’ credit that so much was achieved in raising awareness and in raising the funds necessary for a trial as estimated by our advisor. Our supporters exceeded all expectaions and riased more funds to support critical and valuable research at UCL. Although very much disappointed with this decision we remain optimistic.
Although disappointing the charity feels that there are still good opportunities to perform high-quality research and we will make every effort to continue to lead the way.
Of the 520,000 pounds raised or pledged for the rituximab trial and associated B-cell research 60,000 pounds was spent on the preliminary B-cell study, and 110,000 pounds was given to the follow-on B-cell research which was performed by Dr Jo Cambridge and PhD student Fane Mensah and involved collaboration with the Norwegian Haukeland researchers. An additional 9,000 pounds was also given to fund a student participating in the research and assisting the UCL team for six months.
In total 179,000 pounds has been allocated to UCL for research over the period of 2013 – 2018. What remains from the raised/pledged funds is the original 350,000 pounds estimate for the rituximab trial that had been set by our advisor, plus further funds that have since been raised.