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!

£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.


2. https://www.researchgate.net/publication/316080804_Chronic_fatigue_syndrome_and_the_immune_system_Where_are_we_now

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

Elizabeth’s 8″ Hair Cut for Invest in ME Research

Elizabeth Moon is raising funds for Invest in ME Research and donating her hair to The Princess Trust – www.justgiving.com/fundraising/Elizabeth-moon


By Elizabeth Moon –

Thanks for taking the time to visit my JustGiving page.

I had Glandular Fever when I was 12 and never recovered. Over the following years it morphed into ME via repeated viral infections, each one acting like a nail in my coffin until I became severely fatigued, plagued by a myriad of symptoms, including body-wide pain with migraines 80% of the time, causing me to be mostly housebound and unable to work or socialise.

ME stands for Myalgic Encephalomyelitis.

Myalgic Encephalomyelitis is a multisystem, complex, acquired illness with symptoms related mainly to the dysfunction of the brain and nervous system, gastro-intestinal, immune, endocrine and cardiac systems. ME has been classified as a neurological disorder in the World Health Organisation’s International Classification of Diseases since 1969 (ICD 10 G93.3).

There is no cure, biomedical treatment or biomedical management for ME on the NHS. This is due to the lack of biomedical research on which NICE can base its guidelines. However, worldwide, research has begun to identify the pathological workings involved in ME, has identified possible biomarkers which would enable a definitive diagnosis, begun to understand mitochondrial dysfunction in the production of energy and begun investigating the use of particular drugs in order to treat the disease.

Invest in ME are raising funds to replicate the Norwegian research into the use of Rituximab to treat ME. They are also setting up a Centre of Excellence for ME ‘which would exist to bring discovery, knowledge, and effective treatments to patients with ME’ and they hold yearly conferences and colloquiums to bring researchers, patient groups, patients and carers together to discuss the latest biomedical research.

Until 2 years ago when I came across this wonderful charity, I had resigned myself to a future where there would be no cure, treatment or understanding of my illness. But this charity, by redirecting research in a biomedical direction, has given me hope for the first time.

I will be sending the hair to the Princess Trust so they can use it to make wigs for children going through chemotherapy. This is why I will be having at least 8″ cut off 😱. I’ve always had long hair, being a hippy at heart, but this is the one thing I’m still able to do to raise money for this great charity. And it will be great knowing that somewhere out there, somebody has hair and feels better about themselves while going through a tough time.

Thank you for your support 💜

Share Elizabeth’s story or donate at www.justgiving.com/fundraising/Elizabeth-moon

Marianne is doing that ‘no booze thing’ for 33days plus 100k!

Marianne is supporting the rituximab trial

Marianne is aiming to do that ‘no booze thing’ for 33 days plus 100 km walk to raise £1000 for IiMEs Rituximab clinical trial

In her own words;

“21 years ago my wonderful sister got the dreadful illness, M.E.

M.E. Is a shockingly debilitating illness that can change and affect the entire way the body and brain function.

The symptoms of M.E. are many and wide ranging:

•Extreme fatigue, when even lifting a spoon is an effort.

•Extreme pain when the skin is touched.

•Crazy lack of temperature control. Ha ha, this summer my sister and I went to Nice and whilst I was sat in my swim stuff sunning myself she was fully dressed and wrapped in two towels. She still had goose bumps despite it being 32c!

• every possible digestive problem you can think of!

• ‘brain fog’, when the simple act of reading a sentence becomes an impossible task.

Throughout my sister’s illness as a family we have tried anything and everything available to help get rid of this dreadful disease. Sadly nothing has fixed it.
There has been a groundbreaking discovery that the drug Rituximab – used to treat some cancers – can treat M.E. It is very very exciting! Invest in ME is raising the money to run the trial of the drug.

In order to run the trial in the UK £520,000 needs to be raised. So far £497,000 has been raised, so the trial is in sight!

To raise money for ‘Invest in M.E.’ to go directly to the Rituximab clinical trial I am Giving up booze from 4th October- 5th November and will be exercising 100km each over the course of the 33 days, roughly 3 1/5 km per day with maybe a lengthy walk in there too. 🙂 🏃🏻🏃

We wanna raise money to help find a treatment for this dreadful illness but also to raise awareness of the illness.”

Visit her justgiving page here: https://www.justgiving.com/fundraising/Marianne-100km-no-booze


NOVEMBER UPDATE She did it for ME!

Vintage Life for Joanna’s Violets

Hot off the press! The June 2016 issue of Vintage Life Magazine features a superb account by Laura Chamberlain of Joanna and her Vintage Violet’s Charity Catwalk, held in April at The New Caterham Arms, raising over £1200 for Invest in ME. Earlier this year, Joanna Chamberlain explained why she was organising this spectacular event for the charity in her story on JustGiving.

I am arranging an event that will be raising funds for Invest in ME, a charity very close to my heart. Both my son and daughter suffer from ME. Both of them first became ill as teenagers, went into remission as young adults and unfortunately became ill again with the disease in their mid twenties.

In the sixteen years since my son first became ill, very little progress has been made with research. We know, from the small number of studies that have been funded that there are many biological abnormalities in the body of an ME patient. And yet, there has been very little funding to find effective treatments or even a cure. When my kids became ill again, we discovered that, despite the many years that had passed, doctors still couldn’t offer any kind of treatment aimed at addressing these abnormalities, only therapies to help them manage and live with their condition.

This is where Invest in ME comes in. For researchers, ME is considered to be one of the last few areas of medicine where you can still make a breakthrough. They want to do this research but many of them struggle to get funding. Invest in ME are currently raising funds for a UK trial of a drug called Rituximab. The original studies in Norway were extremely promising. Two-thirds of ME patients given the drug had a major or moderate improvement. But to get this licensed as a treatment for ME, more research has to be done in order to verify the results and look further into why this is so effective.

So hopefully you can see why this is such an important cause. This research gives hope to the 250,000 people in the UK estimated to suffer from ME and they have been waiting a long time for this research to be done. The charity is run entirely by volunteers so 100% of the money raised will go into research.

I set up this page as I know there are lots of people who cant make the event but would still like to donate to this worthy cause – justgiving.com/fundraising/Vintageviolets

Many thanks to Joanna and her Vintage Violets and everyone involved in supporting this event, and congratulations Vintage Life Magazine on the stunning spread in their June issue with article by Laura Chamberlain.

Other credits..

1940s Clothes by Shona Van Beers of Heyday!
Hats by Jo Chamberlain of Hats by Joanna Violet
Bridal Headpieces by Fran Taylor of Crystal Heirlooms
Vintage car Brian and Emma Irving
MUA Manny Samra, Megan Carter Misty Tea and Millie Williamson
Photography Simon Alston Fox, Kevin Waller, Glynn Roche
Music and lighting Ian Phillips of Harrison Entertainment

Find Joanna And Her Vintage Violet’s Charity Catwalk on Facebook

Follow Joanna Violet on Twitter

Buy Vintage Life 67 online

Find your nearest stockists

You may also like Black Dress Day to see ME Awareness Month out in style on 31st May.