Crohn's MAP Vaccine December 2017 Update View this email in your browser CMV Newsletter December 2017

The Crohn's MAP Vaccine trial





‘The phase I trial was completed with no concerns over safety. As it was the first trial of this vaccine in people, a standard ‘



All doses were well tolerated, immunogenicity looks very promising, and the study is now being written up for publication.



We would like to thank the healthy volunteers who took part in this phase I study without whom it is wouldn’t be possible to develop important new therapies.’



Phase IIa, a further safety trial, this time in Crohn’s patients, remains likely to start in the first quarter of 2018, and we will provide further details about this once they become available. The set up period in clinical trials is often unpredictable and as such we are unable to give an exact start date for the phase IIa trial at the present time. Please note that recruitment has not yet started, so we therefore ask our supporters not to contact us or St Thomas’ Hospital about this. The patients recruited to this trial will need to meet strict entry criteria; there are stringent regulations which we have to obey and the trial will be governed by the close scrutiny of the regulators. We are naturally thrilled and incredibly grateful for the support of the Crohn's community world-wide, that after 20 years in the making we're finally about to commence trials on Crohn's sufferers. Phase I of the Crohn’s MAP Vaccine trial was completed, earlier than anticipated, and all the signs were good. The Jenner Institute have given us this statement to share with everyone:‘The phase I trial was completed with no concerns over safety. As it was the first trial of this vaccine in people, a standard ‘ 3+3 dose escalation design ’ was used to allow us to start with a very low dose for the first few volunteers and then gradually increase the dose once we were sure that there were no safety concerns.All doses were well tolerated, immunogenicity looks very promising, and the study is now being written up for publication.We would like to thank the healthy volunteers who took part in this phase I study without whom it is wouldn’t be possible to develop important new therapies.’Phase IIa, a further safety trial, this time in Crohn’s patients, remains likely to start in the first quarter of 2018, and we will provide further details about this once they become available. The set up period in clinical trials is often unpredictable and as such we are unable to give an exact start date for the phase IIa trial at the present time. Please note that recruitment has not yet started, so we therefore ask our supporters not to contact us or St Thomas’ Hospital about this. The patients recruited to this trial will need to meet strict entry criteria; there are stringent regulations which we have to obey and the trial will be governed by the close scrutiny of the regulators. We are naturally thrilled and incredibly grateful for the support of the Crohn's community world-wide, that after 20 years in the making we're finally about to commence trials on Crohn's sufferers. The MAP Diagnostic Blood Test at Kings College London

Technician time in the lab has been increased in order to keep up with the workload involved in validating the MAP blood test. We are pleased to report that this is going very well; Neil and Barry are currently making sure that all bases are covered to reduce the potential for delays after submission for publication. Submission is expected in the New Year, but – as we are constantly told – this will “take as long as it takes” to ensure that nothing is omitted.



We are also pleased to report that Dr Gaurav Agrawal, from The Centre for Digestive Diseases in Sydney, Australia, recently paid a visit to the lab at Kings College, London, and spent some time with Professor John Hermon-Taylor, Neil and Barry.

Fundraising

In November we announced a new fundraising target on our Facebook page of £115,000 over the next two years. Your ongoing contributions will be important as we move into phase 2 clinical trials, during which the lab at Kings College London are likely to be working at full capacity to monitor the trial participants' MAP levels.



All of your fundraising efforts are continuing to bring in donations and the total currently stands at £627,914 as of November 2017. We would like to thank you all for your hard work in raising funds and spreading awareness of the Crohn’s MAP vaccine and diagnostic test, and look forward to seeing what fundraisers and new developments 2018 will bring.



Here’s a taster of some of the fundraisers and events which have been happening over the last few months...



In August, Lisa George ran an online auction with a fabulous selection of handmade art and gift items up for grabs. Some of the items were made by Lisa herself and others were very kindly donated by other artists. The auction raised over £300 for the Crohn’s MAP vaccine. Lisa’s son, Owyn, has Crohn’s disease.



Kimberley Davis-Ward hosted a fantastic Elvis themed fundraising event during Elvis Week, in Memphis, Tennessee. Kimberley suffers from Ulcerative Colitis, and she also has triplets, two of whom suffer from Crohn’s disease. An incredible claim to fame, Kimberley’s late husband and the triplet’s father was one of Elvis’ best friends! As well as raising over $2300 for the Crohn’s MAP vaccine, Kimberley helped spread much needed awareness of the work during the event.



Paul Rebane did a sponsored walk along Hadrian’s Wall in September and smashed his fundraising target. Not only did Paul raise much needed funds – over £900 – he also helped spread much needed awareness of Crohn’s disease and the MAP vaccine research. Paul said “I wanted you to know how much I enjoyed the whole experience despite the fact that at times it was extremely tiring. I met and spoke with many people, some of whom were Crohn's sufferers, and many who were completely ignorant of the condition. At the outset I was oblivious as to how much support there would be for the walk...”



Helen Varney organised another plant stall at the Brecon Artisan Christmas Market in November and raised £83 for the vaccine. Helen also helped raise awareness by talking to lots of people about the vaccine and handing out leaflets.

Debbie Ware knitted children’s hats to sell for the Crohn’s MAP vaccine. There are still a few for sale, so if you are interested have a look on our Facebook group.



Sarah Dawson organised a raffle to win a beautiful limited edition print, 'Jungle Cat', kindly donated by Sarah’s artistic sister who runs organised a raffle to win a beautiful, kindly donated by Sarah’s artistic sister who runs Design By Nikki . The raffle was drawn on 9th December and raised £48. Lastly, but by no means least, we brought you some heartbreaking news in September that one of our long-term supporters, Sue Manolitsis, and her husband Aki, lost their much loved son, Nic, to cancer. Nic was only 25 years old and had been battling Crohn's disease for a number of years. Even in this incredibly difficult time, Sue and Aki continued to fight on for a cure for Crohn’s disease, and they asked for donations for the Crohn’s MAP Vaccine and the Christie Hospital Lymphoma Research Fund in Nic’s memory.









We hope to see more fundraising events taking place next year, and if you would like to get involved in setting up your own fundraiser please get in touch via our Tragedies like this remind us just how badly improvements in the treatment of Crohn’s disease are needed. We will continue to fight on for all those we have lost along this journey, as well as for the future of those who are still with us, to see the Crohn’s MAP vaccine research through to the end.We hope to see more fundraising events taking place next year, and if you would like to get involved in setting up your own fundraiser please get in touch via our website or join our Facebook fundraising and support group Useful links If anyone would like more detail about the fundraising structure of this project, please click here.

For our scientific ‘Core Literature pack’ please click here.

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