A Study Update by Katharine Seton

PhD student Katharine Seton has kindly provided an update via the Invest in ME Research Blog, on the study being undertaken at Quadram Institute, “Defining autoimmune aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”. You can find it at this link where you are also welcome to comment or ask any questions: http://www.investinme.org/ce-blog-1802-01.shtml

Best wishes everyone and thank you for your support!

Rituximab Trial Status November 2017

What had looked to be a promising line of research that could lead to an effective treatment for a subgroup of patients defined by the Canadian Criteria and major understanding of the pathology of this disease has proven to be inconclusive. IiME Research – http://www.investinme.org/IIMER-Newslet-1711-03.shtml

Surprising news from Norway today, but the ground-breaking work continues in UK thanks to all involved and everyone supporting Invest in ME Research, so please don’t be too disappointed, as the charity explains in the following statement published today and reposted below.

Professor Olav Mella recently publicly released early details from the Phase III multi-centre double-blinded placebo-controlled Rituximab Clinical Trial which has been ongoing in Norway for the past year.

Invest in ME Research have been informed by Dr Oystein Fluge of this.

Invest in ME Research have issued this preliminary statement (below).

The Haukeland team will be presenting at the IIMEC13 13th International ME Conference in London on 1st June 2018.

Invest in ME Research Initial Statement
on Norwegian Phase III Rituximab Clinical Trial

November 21, 2017

The statement from Haukeland University, Bergen from Professor Mella is a major disappointment for people with ME and their families.

What had looked to be a promising line of research that could lead to an effective treatment for a subgroup of patients defined by the Canadian Criteria and major understanding of the pathology of this disease has proven to be inconclusive.

Naturally, at the charity, everyone is disappointed. We are disappointed for all the ME patients and carers and families and friends.

We are especially disappointed for all of our supporters and all who have made such generous and tireless efforts to raise funds and awareness of our campaign.

We are very disappointed also for the Haukeland research team – a wonderful team who have brought hope to all patients – and, importantly, brought new insight into this disease and new interest from other areas.

However, we have found, throughout 12 years of trying to change the way that ME is perceived, researched and treated that it is never easy.

It would be easy to give up, to resign oneself to nothing changing, to accept the status quo.

But we think differently.

At the 2017 Colloquium/Conference we invited Karolinska Institutet in Stockholm to present negative results. Because it is important to use negative results for positive effects. Negative results are data and the Norwegian rituximab trial has generated a lot of data that needs to be looked at very carefully.

When we first engaged Professor Jonathan Edwards into research into ME one of the earliest comments he made was that he was pleased to note that our conference did contain negative results.

We see the positives in this research which has been performed by researchers of the utmost integrity who have not made headlines for the sake of it but have thoroughly conducted outstanding research, and still retained a humility that is to their credit and that of their colleagues and team.

We have an excellent research team in Norway which has served the ME patient community and their families with honesty, integrity, professionalism, detemination and an empathy which had never been seen before in this field.

We have established good working relationships between the Norwegian researchers and the UK Centre with input from UCL and UEA/Quadram Institute.

We have data now – more than before.

We have research which IiMER has established and a foundation for the Centre of Excellence for ME.

We have international collaboration in research into ME that will continue.

And we have new plans – already in the making.

The researchers from Haukeland will give more detail on their results and publish a paper or two which will benefit all studying ME.

For us we have invited the Haukeland team to Norwich to discuss the way forward.

We remain positive. Another setback, another day.

We have already been in discussion with our advisors and with the Norwegian team and we will meet to clarify the best way forward in the near future with our major funder and researchers.

We still have much good research being funded and being planned and feel our stategy is, and will pay off and lead to most rapid route to finding cause(s) of ME and effective treatments.

In another age, and in another struggle which has some parallels to that which is forced upon people with ME, these words strike a chord –

“ We must accept finite disappointment, but never lose infinite hope. ”

– Dr Martin Luther King

Source: http://www.investinme.org/IIMER-Newslet-1711-03.shtml

We are sorry to share disappointing news but encouraged that this presents the next step to achieving tests for differential diagnosis and effective treatment options for people with ME.

The charity’s B-cell/UK Rituximab Trial microsite is now here: http://www.investinme.org/ukrtbcell-ce-index.shtml

Thank you for your support!

£200k target hit for IiMER Gut Microbiota Fund!

You’ve done it again!

We are pleased to announce that another target for our crowdfunding campaign for a strategy of biomedical research into ME has been reached.

This update to our gut microbiota and related projects fund being performed at the UK Centre of Excellence for ME hub in Norwich Research Park brings the total raised so far for projects there to £200,000.

The research found, funded and facilitated by Invest in ME Research is the result of dedicated, generous and determined supporters who have not just given money but, also huge amounts of time and effort toward helping us change the direction of research into ME in UK and Europe.

The latest target has allowed us to fund two PhD studentships currently undertaking research at the Centre of Excellence hub in Norwich Research Park and allowed us to decide to commit to the future funding of another PhD at the Centre.

Please click here for the full update by Invest in ME Research giving details of the latest study in the biomedical research programme and other projects related to the UK Centre of Excellence for ME, and a message to you from the charity’s Chairman Kathleen McCall: http://www.investinme.org/ce-news-1709-04.shtml

We supporters at Let’s Do It for ME would like to thank the Trustees and Scientific Advisory Board of Invest in ME Research for their vision and dedication, and everyone working with them to establish diagnostic tests and medical treatment options for some 250,000 people with ME in UK and millions around the world.

Our thanks to each and every individual, family, group, team, organisation or company contributing to this vital research and supporting by whatever means.

Let’s keep doing it for ME!

We now have a fundraising page on BT MyDonate: https://mydonate.bt.com/fundraisers/fundraising4me1

£520k target hit for IiME Research Rituximab Fund!

You did it for ME! Let’s keep doing it! We supporters at Let’s Do It for ME would like to thank each and every individual, family, group, team, organisation or company contributing to this vital research and supporting by whatever means.

We would of course, also like to thank the forward-thinking and incredibly hard-working Trustees and Scientific Advisory Board of Invest in ME Research and all the other volunteers and researchers working with them to establish diagnostic tests and medical treatment options for some 250,000 people with ME in UK and millions around the world.

Please click here to read the full update by Invest in ME Research, where you will also find info and links to the charity’s various other projects related to developing a UK Centre of Excellence for ME needing further funding, such as the Gut Microbiota Research, education for medical students and the charity’s international biomedical research conference events: http://www.investinme.org/ce-news-1708-01.shtml

We have reposted an extract below.

Well done everybody and thank you for your support!

Invest in ME Research has now reached the target set for the B-cell/rituximab fund.

This is another major target reached and is a wonderful achievement by dedicated supporters and friends across the world. The total of funds raised or pledged for B-cell/rituximab projects is £520,000.

From this the charity has already funded research at UCL, including a PhD student, and allowed strong collaboration to be formed with the researchers at Haukeland University Hospital in Bergen, Norway.

The initial preliminary B-cell study at UCL looked for likely responders and also introduced the UCL team to research into ME [1], leading to a UK rituximab trial.

This early work also created the foundations of close collaboration between the UK team and the Norwegian researchers at Haukeland University Hospital in Bergen.

This working collaboration and the work performed at UCL was credited as enormously valuable to the Norwegian rituimab trial work by one of the specialists there.

Once it became clear that a reorganisation at UCL would mean the UK trial could not take place there, and once it was decided that the trial could proceed at Norwich Research Park, then further collaboration was made and the Norwegian team visited Norwich in force in January 2017 to discuss with the UK team – UEA, IFR (now Quadram Institute Biosciences) and UCL – at the Centre there – click here.

As we now make preparations for the next phase, a new visit to Norwich is planned for when the Norwegian team break the codes for their Phase III trial later in 2017.

From the £520,000 raised Fane Mensah was also funded with a PhD grant to continue the B-cell research which is so important. This work was described here (click here).

Recently this work has been expanded thanks to a grant from Solve ME/CFS in USA which allowed Fane and Chris Armstrong to collaborate (click here).

Chris and Fane met when both were invited by IiMER to the sixth Biomedical Research into ME Colloquium (BRMEC6) in London in 2016. Dr Zaher Nahle from Solve was there also, and so another collaboration ensued. The work funded by IiMER has produced this paper from Fane and collaborators – Chronic fatigue syndrome and the immune system: Where are we now? [2]

Our initial target of £350,000 which was set with our advisor some years ago was reached and allowed the additional B-cell research to take place.

A position for a Senior Research Assistant to help with the UK trial is being advertised.

Our plans are to continue to raise funds for the UK Centre of Excellence for ME where international collaboration is a key concept.

We are pleased that Professor Ian Charles of Quadram Institute discussed the possibilities with the Centre in his keynote speech at the recent IIMEC12 International ME Conference in London (DVD available here). Professor Charles stated that he hoped “…they were being ambitious enough” for the Centre.

Our thanks to the wonderful supporters who are making it possible to apply high-quality science to looking for the cause(s) of this disease.

Our dedicated microsite for the UK rituximab trial and B-cell research has more details.

We are working on updating that site shortly and will include it in the Centre of Excellence microsite.

We will also be introducing a blog section which will allow the IiMER-funded researcher to interact more.

We hope to begin that soon – more details here.

Our mascot, Professor Let’s Do It for ME, was created by our supporters and indicates the B-cell/rituximab total – posters by LDIFME’s Jan Laverick.

Please help us by supporting our campaign for the
UK Centre of Excellence for ME.

Ways to help us are shown in the column at the right of our page.

References

1.
http://onlinelibrary.wiley.com/doi/10.1111/cei.12749/pdf
2. https://www.researchgate.net/publication/316080804_Chronic_fatigue_syndrome_and_the_immune_system_Where_are_we_now
3.
http://investinme.org/ce-news-1702-01.shtml

Read more here: http://www.investinme.org/ce-news-1708-01.shtml

From Norway to Norwich – IiMER Rituximab Trial Update

Haukeland Team to Visit UK for Rituximab Trial Planning and Public Talks

Dr. Øystein Fluge and Dr. Ingrid Rekeland from Department of Oncology and Medical Physics Haukeland University Hospital, Bergen, Norway, will be joining Professor Simon Carding from the Institute of Food Research (IFR) and University of East Anglia, for an event being held at The Assembly House in Norwich on 26th January, from 6.30pm to 9pm.

The meeting is open to the public and and the talks will be CPD-accredited.

Admission is free and places may be reserved by contacting Invest in ME Research by using the contact form on their website, or by emailing the charity at info@investinme.org with subject title Dr Øystein Fluge Public Talk.

fluge-norwich
The public meeting will be a great opportunity for awareness of ground-breaking biomedical research into ME (Myalgic Encephalomyelitis) of the highest quality.

However, the main purpose of the visit by Dr. Fluge and his team is to discuss the UK clinical trial of rituximab as a treatment for ME, planned to be conducted in Norwich, the hub of the Invest in ME Research Centre of Excellence for ME. From an article on IFR News and Events –

Dr Øystein Fluge, a senior consultant and oncologist at Haukeland University Hospital in Norway will be talking about ground-breaking research he is leading on Rituximab. This drug has been used to treat leukaemia and lymphoma, as it targets B-cells, a type of blood cell. In 2004, Dr Fluge noticed that ME patients being treated for lymphoma with Rituximab also saw substantial improvements in their ME symptoms. Subsequently pilot studies and a randomised, blinded, placebo controlled study also showed positive results, with a large, multi-site Phase III clinical study now running.

Dr Fluge is visiting Norwich to collaborate over another Rituximab trial being carried out on the Norwich Research Park. Professor Simon Carding from the Institute of Food Research (IFR) and University of East Anglia will also be talking about at the event about this, as well as research in his own group, who are looking for causes and treatments for ME in the gut and its microbial communities. The Norwich Research Park is establishing itself as a hub for biomedical research into ME, in the UK and Europe and through international collaborations.

Read in full at http://www.ifr.ac.uk/news/events/2017/01/mecfs-biomedical-research/

Solving Complex Disease With High-Quality Biomedical Research and International Collaboration – Invest in ME Research (IiMER) wrote –

We are pleased to announce that Dr Øystein Fluge and his team from Haukeland University Hospital in Bergen, Norway, will be visiting the Norwich Centre to continue and extend the collaboration between IiMER-funded researchers as the plans for the UK rituximab trial develop.

Already the IiMER funded researchers have been collaborating with Dr Fluge and Professor Mella and the team in Bergen – with Dr Jo Cambridge and Fane Mensah both having visited Norway as part of their continued collaboration to study the potential role of B cells in ME and they continue this collaboration.

IiMER also funded our advisor, Professor Jo Edwards as the first to visit Bergen back in the autumn of 2013.

This close collaboration benefits all researchers involved and is greatly appreciated.

Establishing biomedical research into ME and arranging clinical trials is not, and has not been easy. Invest in ME Research have been working tirelessly for many years attempting to foster, encourage, find, facilitate and eventually fund high-quality biomedical research which is built on a strategy which will lead to an understanding of the aetiology of this disease and the development of treatments.

Our strategy is also founded on international collaboration – of the right stuff.

This development is a further example of that strategy taking effect.

Read in full at http://www.investinme.org/ce-news-1611-02.shtml

The international collaboration fostered by Invest in ME Research extends beyond Europe. The charity’s 2016 international conference events enabled UCL B-cell/rituximab researchers Jo Cambridge and Fane Mensah to meet Chris Armstrong from Australia and Zaher Nahle, Vice President for Research and Scientific Programs at Solve ME/CFS Initiative. The USA organisation selected the three UK and Australian researchers as Team Two to benefit from their inaugural Ramsay Award Program, for a study of B-Cell Function, Maturation, and Biochemical Alteration with Rituximab-Based Therapy, a welcome addition to the IiMER funding of this aspect of their UK Centre of Excellence translational biomedical research strategy. Details here – http://solvecfs.org/ramsay-research-team-2-studying-b-cell-function-maturation-and-biochemical-alteration-with-rituximab-based-therapy/

Fane Mensah also gave a poster presentation at the IACFS conference at Fort Lauderdale in Florida, thanks to a travel grant awarded by Solve ME/CFS Inititaive, meeting up again with Team Haukeland, pictured below showing support for the Invest in ME Research Centre of Excellence for ME. More here – http://www.investinme.org/ce-news-1610-03.shtml

fane-bergen-team

£1/2 million Raised/Pledged for B-cell Research/Rituximab Trial – on the subject of funding and support for the IiMER UK Rituximab Research, the charity wrote

In 2013, following the BRMEC3 Colloquium, Invest in ME and its supporters honoured the commitment made by the charity a year earlier, at the IIME7 conference in 2012, to initiate a UK rituximab trial project.

Thanks to a wonderful group of supporters and support which came from around the world and the generous donations from people who want to see progress in the treatment of ME, this campaign was started and soon it was on its way to initiate research which had the opportunity of overturning the way things had been done, or not been done before.

An attitude of CAN DO instead of can’t do is the ethos of IiMER and this is supported by the WILL DO attitude of the Let’s Do It For ME campaign.

Then one event of enormous significance occurred with a magnificent gesture from the Hendrie Foundation to support the charity’s rituximab project and its strategy of international collaboration with a pledge eventually totalling £275,000, together with an initial donation of £25,000, which allowed this research to become reality and to move things on more quickly.

The work progressed with the team at UCL where it was decided early on that a preliminary B-cell study ought to be performed in order to try to replicate the B cell findings of Bansal et al. and to determine likely responders to the drug. This was something that our advisor and the UCL department thought was necessary.

This was initiated in 2014.

PhD student Fane Mensah is now continuing this B-cell research with Dr Jo Cambridge – again funded by IiMER.

This is important work and it is being enhanced by the international collaboration which we have encouraged and facilitated.

During this time the research team has collaborated with the researchers at Haukeland University hospital in Bergen, Norway – where work on a series of rituximab trials began to take shape as early as in 2004 – facilitated by IiMER’s Colloqiums, conferences, EMERG meetings, our strategy for international collaboration and our supporters.

After preliminary B-cell study was underway there was an internal reorganisation in the clinical trials unit (CTU) at UCL which resulted in the principal investigator being moved away from the project and the CTU being downsized. When this was communicated to the charity then we began to look for alternative solutions.

The trial was advertised on our web site in order for interested parties to apply to the charity and at the same time the charity actively continued to look for a place for the trial as the B-cell research continued.

The preliminary B-cell research paper was published in 2016.

After an expression of interest from UEA/IFR it was agreed to relocate the rituximab trial to Norwich Research Park, home for the UK Centre of Excellence for ME.

In January Dr Oystein Fluge and his team will visit Norwich to work with the UK researchers in planning the trial.

The original target for the rituximab trial was set by our advisor back in 2013. Having shown great vision and determination in looking at other areas of research linked to their phase III trial experiences and developing an incremental, evolutionary method of research then we feel the Norwegian Haukeland researchers have exactly the model of how good research should proceed. With the progress made by the Norwegian researchers and the increased knowledge now gained by them it will be interesting to see how the UK trial planning will progress with this new collaboration.

The objectives of the charity have been international collaboration and we are very pleased that a great deal of European collaboration in research into ME has already been occurring and continues.

To initiate the B-cell research and the UK rituximab trial has been a major effort and we owe so much to dedicated supporters from around the world. The charity has had donations and pledges from many organisations and individuals around the world.

They have believed in the charity and the research.

We welcome support still for this research. Donations or pledges can still be made in support of the Invest in ME Research-led project.

Read in full at http://www.investinme.org/ce-news-1611-03.shtml

UPDATES

The video clip below of the Haukeland ME team on Norwegian TV news talking about their latest study now has English subtitles added. They say once again very clearly that ME is a physical disease and it can be treated. Good to hear these objective and careful researchers sounding so positive.

Another excellent news clip featuring an interview with Dr. Fluge on his team’s latest findings and their rituximab trial now also with English subtitles. The clip also features Norwegian advocate and mother of three children with ME, Kjersti Krisner, who gave the pre-conference dinner presentation at the Invest in MR Conference events in London in 2016, inlcuded on the IIMEC11 DVD. Read about it here – http://www.investinme.eu/IIMEC11-news%20Pre-Conf-Postscript.shtml


NEW YEAR DONATIONS UPDATE for B-CELL/RITUXIMAB RESEARCH

Links –

IFR News and Events- Public Lecture in Norwich on ME/CFS biomedical research

IiMER- Solving Complex Disease With High-Quality Biomedical Research and International Collaboration

IiMER Rituximab Trial Update- £1/2 million Raised/Pledged for B-cell Research/Rituximab Trial

Ways to Donate

Funders and Supporters of the IiMER UK B-cell/Rituximab Research

IiMER is an independent charity run entirely by volunteers. They have no paid staff, no income from government funds or membership fees.Thanks everyone supporting Invest in ME Research
and their Centre of Excellence for ME