Project Information

Quick Overview of the IiMER UK Rituximab Project

• Invest in ME Research have initiated a UK Rituximab Project. This is being progressed.
• Our advisor has been Professor Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL)
• The clinical trial is intended to be performed when the preliminary research has produced sufficient data to enable the trial to begin and when the researchers involve feel that the project definition is sound enough to enable a sound scientific project to be performed.
• There has already been some preliminary research in B cell immunology performed under the supervision of Dr Jo Cambridge at UCL.
• The research is being set up in collaboration with clinicians with expertise in ME from around London, and in particular Dr Amolak Bansal.
• The original plan was for UCL to perform the clinical trial. Due to internal reorganisationa and downsizing of the clinical trials unit there, which led to reassignment of the PI, a decision was made to continue to perform B-cell research at UCL which augmented the work being performed by the Norwegian researchers at Haukeland University Hospital in Bergen whilst a new location was found for a possible trial.
• The new location for a trial was eventually decided to be based in Norwich Reseaerch Park which is where Invest in ME Research have been focusing effort to develop a UK Centre of Excellence for ME hub which would perform a strategy of biomedical research into MEand clinical trials.
• External peer reviewing of a rituximab trial will be arranged by Invest in ME Research.
• Invest in ME Research already organised a visit to Bergen by Professor Edwards to meet Dr Fluge and Professor Mella to discuss their clinical trial in detail - thus enhancing cooperation and research.
• Invest in ME Research fully funded the preliminary B-cell study by UCL which was designed to be a pre-cursor to a full clinical trial. This was completed.
• The preliminary study aimed to confirm the earlier work of Dr Amolak Bansal [1] on B-cells but using a different cohort of ME patients. Professor Edwards believed this was a useful study in its own right and a pre-requisite for the clinical trial.
• The fundraising for this trial is being organised and coordinated by IiMER so please contact IiMER directly if you or your organisation would like to contribute. Our unique MATRIX crowdfunding scheme will allow multiple funders to easily contribute to the IiMER UK trial funding.

References

This status may be downloaded using this pdf link

At our 6th Invest in ME Research International ME Conference in London in 2011, Norwegian cancer specialists Dr Øystein Fluge and Professor Olav Mella announced strikingly successful results in their pilot study of the immunotherapy drug Rituximab on ME/CFS patients. In that study [R1 67% of ME/CFS patients had moderate to major improvement, compared to only 13% of controls.

The pattern of response indicated that ME may have an autoimmune component because rituximab works by temporarily wiping out immune-system B cells, which are implicated in autoimmune disease.
These groundbreaking results gained international attention when the study was published.

In Germany, Professor Carmen Scheibenbogen was already looking at possibilities for a rituximab trial and in the US, Dr Andreas Kogelnik’s Open Medicine Institute was raising funds for a study.
Dr Fluge and Professor Mella are beginning a confirmatory trial in January 2014, part-funded by the Norwegian government; at our 2013 conference, they presented further evidence of the efficacy of rituximab in the treatment of ME patients.
 

Multiple confirmatory trials are crucial because without evidence on safety and efficacy from independent studies in several locations, regulatory bodies will not approve or license rituximab for use in ME.

We believe that the UK needs a rituximab trial, both to benefit UK patients and to support the international effort. With your help, we can make this happen.

At the 2012 Invest in ME Research International ME Research conference IiMER announced we were looking into starting a rituximab trial in the UK. From the time of the 2012 conference we spent a year working on that idea as part of our efforts in setting up a UK Centre of Excellence for ME in Norwich.

We contacted universities throughout the UK in an attempt at raising interest for biomedical research into ME and for a clinical trial of rituximab for ME patients. We invited many to our BRMEC3 colloquium in London in May 2013. From that meeting the researchers from UCL whom we had contacted expressed interest in the idea and agreed to work on helping this project.

On 6 June 2013, we announced that we were initiating a UK rituximab trial and began fundraising for it.

Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL), has agreed to advise us on all aspects of the trial. He is known worldwide for his work in B cell immunology and as lead researcher in the clinical trials of Rituximab for rheumatoid arthritis. No UK expert is better placed than Professor Edwards to advise us on setting up a rituximab trial for ME patients.

You can read his statement on the trial here.

The preliminary B-cell study for this project was started and completed at UCL. It was conducted by the same team that carried out the rituximab research in rheumatoid arthritis and who had considerable laboratory expertise in B cell immunology. This was seen as the best possible team in the UK to carry out this work and we are confident that we can make this happen quickly.

As mentioned above due to internal reorganisation at UCL it was ot possible to continue with plans for the trial to be held there. We therefore looked for a new venue and Norwich Research park was chosen, whilst continuing B-cell research continued at UCL.