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Published: October 23, 2015

Crohn’s symposium gives patients hope

Writing from Chicago

Photo: Julia Ciaccio, Jules Photography
Author Stacey Sturner seen in a 2015 photo with her two sons, whose names she has asked to be withheld. The oldest son, wearing a blue t-shirt, was diagnosed with Crohn’s disease about a year before the Crohn’s symposium held in Deerfield, Illinois in August 2015.

Sunday, August 16, 2015 started out like any other weekend day...if you tend to spend your time in the company of brilliant doctors and researchers who have dedicated their lives trying to pinpoint the root cause of Crohn's disease. I do not usually.

However, on that particular beautiful summer afternoon, five world renowned experts (plus, a special guest) – from the U.S., Israel, the U.K. and New Zealand – joined together to share their latest and, in some cases, groundbreaking findings during the “International Research Symposium: Game-Changing Concepts in Crohn’s Medicine” at Congregation B’nai Jehoshua Beth Elohim in Deerfield, Illinois, a north suburb of Chicago.

I was fortunate enough to not only be in attendance, but to help coordinate this landmark event that attracted approximately 115 guests and raised a little less than $10,000 for ongoing Crohn's research, with the proceeds split evenly among the featured presenters’ respective charitable projects.

First up at the podium was Dr. William Chamberlin, a gastroenterologist from Las Cruces, New Mexico, who began with an overview of Crohn’s and general concepts providing context for material to come. Dr. Chamberlin is just one of a handful of gastroenterologists worldwide who use an anti-MAP Protocol involving multiple antibiotics to treat Crohn’s. [An extensive interview with Dr. Chamberlin can be found on the homepage of this site.]

After an early intermission due to technical difficulties, Dr. Michael Collins of University of Wisconsin in Madison presented that Mycobacterium aviumsubspecies paratuberculosis (MAP) is a pathogen that most often infects ruminant animals, such as cattle. However, it is also capable of infecting a wide range of other animal species, including non-human primates. 

Food from infected animals is commonly contaminated with MAP, and food manufacturing practices such as pasteurization kill many but not all MAP. MAP, in fact, has been cultured (found alive) in retail pasteurized dairy products, he said. Thus, there are many ways humans can be exposed and it is highly likely that MAP is capable of infecting humans and causing disease. [An extensive analysis by Dr. Collins tying Johne’s disease in ruminants with Crohn’s disease in humans can also be found on the homepage of this site.]

Patrick McLean, product manager of RedHill Biopharma, an Israeli biotech company which has developed a triple antibiotic anti-MAP therapy known as RHB-104 for Crohn’s, was next, representing the charitable interests of Dr. Thomas Borody, an Australian gastroenterologist and one of the anti-MAP therapy pioneers.

Mr. McLean summarized the RHB-104 clinical studies currently under way, suggesting they could lead to some of the best remission rates ever published on the treatment of the disease. He stated that this particular anti-MAP therapy may be effective for a large number of Crohn’s patients, but a sensitive and specific diagnostic for MAP infection needs to be developed to establish the cause of Crohn’s. This is one of the key elements of RedHill’s large Phase III clinical trial in progress among 270 patients in the U.S., as well as among patients in Canada, Israel and other countries.

There were two speakers in the diagnostics category. Dr. Amy Hermon-Taylor (GP/family physician) presented the research of her father, Prof. John Hermon-Taylor of King’s College London. A compelling body of evidence supports MAP as the “prime suspect” in the causation of Crohn’s, she said. To confirm or refute this, it is critically important to have a sensitive, specific and reproducible test for MAP, without which research in this area cannot move forward, she added. (Current tests lack sensitivity and results have varied widely among different research groups.)

Dr. Hermon-Taylor said that her father and his colleagues have developed a new test, applicable to both blood and tissue samples, which fulfills these essential criteria. Applying the test to blood samples – using a “flow cytometry” assay – offers a simple, rapid, quantitative diagnostic ideal for use in a clinical setting. Applying the test to intestinal tissues of people with Crohn’s – using an “immunofluorescence” assay – allows researchers to see MAP, in intricate detail, for the very first time, she said. This not only enables diagnosis, but also offers a wealth of new insights into mechanisms of disease in Crohn’s.

Confirming the cause of Crohn’s will establish a therapeutic target, setting the medical community on the final pathway to curing the disease at last, she said. And if that therapeutic target is confirmed as MAP, then the new therapeutic anti-MAP vaccine developed by her father, Prof. John Hermon-Taylor, offers hope for a cure. The vaccine is currently being manufactured by the Jenner Institute, Oxford (also responsible for developing the Ebola vaccine using very similar technology).

The vaccine is currently in the Pre-GMP (Good Manufacturing Process) phase of manufacture. GMP manufacture was expected to start in October 2015 and will last one year. Phase I trials in healthy human volunteers are expected to begin in June 2016.

These will be followed by a Phase II trial, anticipated to begin in February 2017. The Phase II trial will be a single-centre trial conducted at St. Thomas' Hospital in London, will last one year and will involve 20 adults with Crohn's disease.
The patients recruited to this trial will need to meet strict entry criteria and the results will be analyzed in real time as it proceeds.

As soon as there is evidence of safety and efficacy, Dr. John Hermon-Taylor and his colleagues can apply for use of the vaccine on compassionate grounds. This will enable people who wish to have the vaccine but are unable to be part of the trial to access it on a named-patient basis outside of the trial.

Indeed, under the newly proposed “Early Access to Medicines” scheme in the U.K., severely ill patients who have failed existing treatments may be granted access to new medicines that are proven to be safe, even before efficacy has been fully established. This means that the earliest the vaccine could be made available to patients on a named-patient basis would be late 2017. 

In addition, following the demonstration of safety and efficacy, it is anticipated that the vaccine technology would be licensed to a pharmaceutical company to make it available to all who need it through health services worldwide as part of larger Phase III trials inviting wider participation.

The manufacture and trial of the vaccine is being funded through investment in the company HAV Vaccines Ltd. (HVL) Completion of the trials is dependent on HVL to secure the remainder of the funding required.

A Q & A about progress on the development of Dr. Hermon-Taylor’s vaccine can be found at

John Aitken, a medical laboratory scientist from New Zealand with more than 35 years of experience in mycobacteriology and emerging infectious diseases, also described the diagnostic test that his lab has been using. Instead of using DNA, his lab is growing an organism cultured from the blood of Crohn’s patients they have termed “Son of MAP,” because this variant differs considerably from the conventional strains of MAP detected in cattle and thought to be associated with Crohn’s.

“Son of MAP” has features of MAP; however, it would not be found using existing bacteriological techniques, Mr. Aitken said. There was one slide that showed a four-day “Son of MAP” culture that had all but eaten away the media and covered the entire plate. Mr. Aitken detailed five forms he has observed in this organism, of which the persistent form is commonly seen in long-term Crohn’s patients.

Lastly, Dr. Chamberlin introduced EpiBro, a new therapy that his company is readying for testing. He described how Crohn’s patients have a genetic innate immune system defect that does not allow them to effectively kill the mycobacterial species. EpiBro, he said, has shown great promise with few side effects in HIV/AIDS, tuberculosis and malaria patients because it:

  1. Stimulates innate immunity, which Crohn’s patients are unable to accomplish on their own
  2. Down-regulates damaging inflammation resulting in less tissue damage
  3. Resolves the infection by enhancing immunity

A newly formed company, Immunikas, hopes to begin human trials for EpiBro soon.

A last minute addition to the program, Dr. David Rubin, section chief of gastroenterology, hepatology and nutrition from The University of Chicago Medicine, spoke about genetic associations with Crohn’s and stated that he used anti-MAP therapy as one option in his practice. He was engaging and gave an overview of the research being done by his group, including investigations into the microbiome.

Following the final word, many guests stayed for an informal reception with the presenters. It was the perfect blend of science and social opportunities for Crohn’s patients – some currently on anti-MAP therapy and some interested in starting based on what they learned during the day’s presentation – to compare their personal experiences. This included the parents of several young children excitedly chatting away about how well anti-MAP therapy has been working for them.

Contact information was exchanged, hugs were shared and a rousing rendition of “Happy Birthday” was belted out to Dr. Amy Hermon-Taylor, who celebrated her 40th birthday the week prior. When all was said and done, Crohn’s history had been made by bringing together these bright minds for the first time ever to shine light on MAP as a primary causal agent. Those of us in attendance will never forget it.

To view a video series of the symposium presentation and/or donate to the ongoing efforts, please visit:

[Australian doctor leads Crohn's treatment]

[Crohn's is linked to bacterium in cows]

© Stacey J. Sturner. All Rights Reserved. Publication by 2012-2024.
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