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Crohn's Disease Forum » Books, Multimedia, Research & News » MAP Vaccine Ready for Human Trials - Could be Used for Crohn's


 
02-12-2014, 04:27 PM   #61
AJC - Australia
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I have been in touch with the Professor. I asked him if I could share his email. He said YES>….SO here it is…and I made some comments below it.

This is where we are.
1. We have a modern T-cell vaccine which worked in mice and has given us fantastic anti-MAP action in cattle with no apparant side effects lasting as long as we had funds/time to go on testing (44 weeks) and reversing the dysregulation that MAP specifically imposes on the immune systems of both infected cattle and humans. Promises to be a game-changer in Crohn's disease (CD).
2. I have developed a practical clinical diagnostic for MAP in humans and am finalising this year the relevant clinical reagents.
It confirms all people with CD are MAP infected.
3. The UK gov TSB turned down our application for funding to 'GMP' manufacture the vaccine required for human use.
Don't know why. It was bloody good.

The vaccine.
The vehicle for getting the vaccine into the clinic where it belongs is a UK company HAV Vaccines Ltd No.6962730 (HVL) which
has obtained and owns all the patents running out to Jan 2027.
We are out there looking for the funding again.
Got several leads....nothing concrete yet. Big Pharma not interested until after the first human trials.
Getting the 2 components of the vaccine made to do these costs UK£1.2 million and £500,000.
In the present model the cost of the whole project with completion of approved Phase I and Phase IIa Clinical trials as a new treatment for CD is UK£4 million.
We have been trying for 4 years to get this from any source and have learned it is just too much for private investors.
We have a meeting with our collaborators at the Jenner Vaccine Inst Oxford University on Feb 20th.
We think we can get this figure down to not > £2.2 million doing it our way but within the regulations.
We also think this would be achievable from private investors say 22 each doing a £100K purchase of stock.
44 HNW CD families each investing £50K....yes....but more than that may get difficult to manage.
Crowd funding ? Could take a long time to get to that done ? Would probably need to have a CD Vaccine Trust set up to receive donations
independently which then invests. Returns go back to the Trust for use as determined by the Trustees (not us) but to further
the treatment and prevention of diseases caused by MAP (probably a large chunk of the IBS too...attached with... another paper worth a look).

The new MAP Test
Companion diagnostic for the vaccine. v good v important. Shows who needs to be treated and how they respond. Will go into HVL.
Currently in the final stage development here by me and 1 v. good lab worker (who has been on a building site for 3 months with the work
stopped as the funding had run out. Just back yesterday thanks to a $50K donation from the father of a 13yr CD daughter in the US, and my own lovely daughter running in a marathon collected £10K). 3 grant applications in 2012/3 rejected by 'peer review' essentially as the gastros think it is all rubbish.
Funding has to be independent. What does it need?
About £80K to get all the reagents done, validated and ready to go clinical...10 months.
Clinical validation £300K over 2 years running parallel with the vaccine so it does not take more time.


What I have proposed to the professor is to start a crowd-sourcing kickstarter esq fundraising effort regarding his MAP diagnostic. Currently you cannot get accurately tested for the MAP bacteria. The professor has a method to clinically test for it, but he needs funding to make it affordable/streamlined for the publics accessibility. The QUESTION i ask to the members of this forum is this
- If you could get a test done which says you have a rampant MAP infection in your gut, would you then be interested in investing in the vaccine? and How much would you pledge to have the test done in the first place?
02-12-2014, 04:36 PM   #62
rollinstone
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I'm not very rich but I would pledge 500-800 dollars.
02-12-2014, 11:04 PM   #63
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I would certainly pledge $500
02-13-2014, 03:33 AM   #64
Malgrave
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My son's biopsies have often shown epitheloid granulomas with necrosis and last year the doctors decided to do PCR reaction test and found some sort of mycobacterium. Then they tried to culture it but the result was negative. I still believe that with the right test they might have been able to diagnose MAP infection.

For Happy Poo Poo's question I would thus say definitely yes! And would be willing to pledge one month's salary or so, at least.
02-13-2014, 04:27 AM   #65
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I would also pledge a month's salary. The amounts mentioned by Prof HT (£80k and £300k for the next stage) are achievable! I know of other people who have children and grandchildren with Crohn's who would definitely be interested in making a pledge.
02-13-2014, 06:38 AM   #66
sir.clausin
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I saw this ...

I really hope this is the truth, I can´t stand this disease any longer, I am loosing my job, family over it.

Last edited by Jennifer; 03-27-2014 at 02:48 PM. Reason: Findraising link removed. Against forum rules.
02-13-2014, 07:53 AM   #67
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Yes, I wouldn't be able to give much but would be more than happy to give a donation. I want my happy healthy husband back.
02-13-2014, 02:17 PM   #68
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I saw this ...

I really hope this is the truth, I can´t stand this disease any longer, I am loosing my job, family over it.
Unfortunately we can't post links were they ask for money :/
02-13-2014, 02:19 PM   #69
electrichead
 
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Everybody PLEASE go to the "Run for Crohn's" facebook page
02-13-2014, 04:26 PM   #70
AJC - Australia
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very good everyone!!!
the next step here is to start this crowd sourcing campaign!
I have been communicating with professor hermon-taylor and any relevant communication I will put on here, for now - but i hope soon we will be able to point people to a page with a short video and information about his work - with easy steps in place to contribute towards his mission for the MAP vaccine.
cheers
02-14-2014, 02:33 AM   #71
Malgrave
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The video is an excellent idea!!!
02-15-2014, 12:51 AM   #72
sir.clausin
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Morning!

I am going to speak with Amy today, the professors daughter, over the phone. I am all in for this. Do you guys have any specific questions that I could bring with me?
02-15-2014, 02:17 AM   #73
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Just quick thoughts:
- the vaccine for cows: state-of-play? is it completely ready?
- the test to find MAP bacteria: would it be possible for someone e.g. from this forum to have it done? If yes, how? (See Happy Poo Poo's earlier question: would you be ready to invest if the test showed that you have it?). The positive test result might attract more investors...
- have they applied for funding from the EU research programmes?
02-15-2014, 03:36 PM   #74
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http://www.abc.net.au/site-archive/r...3/s3682553.htm

Worth reading….from Australia.
It is an antibiotic treatment heading to human trial in the US….backed by a company from Israel.
This is not the same as the vaccine by Hermon-Taylor, but it is in the same genre ie MAP and treating MAP.
02-16-2014, 02:21 PM   #75
sir.clausin
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Hey guys!

Ok, so I spoke to Amy over the phone, the professors daughter, yesterday....very interesting indeed. I am joining the team to work for the vaccine to come out and spread the information.

Can everyone who is interested in helping out please pm me. I know happy poo poo have a dialog with John already. I asked about the crowdfunding btw. and eventhough they think its a good idea, Amy and John think it´s going to take too long. John is actually going to apply for foundings, can´t remember from where but he is.

It would be nice to talkt to those of you who wants to help over Skype to exchange ideas etc.
02-16-2014, 02:44 PM   #76
durwardian
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Can you setup a paypal donation site for the group to help drive people to?
02-16-2014, 02:55 PM   #77
Igor_Passau
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I am with you.
Pls aks in what country clinical trial could be made more "simplified", without burocrasity!
02-16-2014, 02:59 PM   #78
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I have information that some clinical services can be offered in Mexico! It could more easy if we could arrange medical services in neutral zone!
02-16-2014, 03:08 PM   #79
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I would bet there are plenty of volunteers
02-16-2014, 03:17 PM   #80
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In September 2013 RedHill initiated a first Phase III clinical trial with RHB-104 for Crohn’s Disease in North America and Israel. A second Phase III trial, in Europe, is planned to commence in the first half of 2014.

RedHill further acquired an exclusive license from the University of Central Florida Research Foundation, Inc. to a patent-protected diagnostic test for the detection of MAP (Mycobacterium avium paratuberculosis) bacterium, and is developing the diagnostic test with Quest Diagnostics.

http://www.redhillbio.com/product-pipeline/rhb-104/
02-16-2014, 03:19 PM   #81
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240 subjects will be randomized into the MAP US Study across up to 50 sites in the U.S., Canada and Israel. The primary endpoint for this study is the state of remission at week 26 in subjects randomized to receive RHB-104, as compared to subjects randomized to receive placebo. Secondary and exploratory endpoints will include, among others, state of response at 26 weeks, maintenance of remission through week 52 and efficacy outcome measures in relation to presence of MAP (Mycobacterium avium paratuberculosis) bacterial infection. The study is exploratory with respect to the clinical validation of the Company's proprietary Polymerase Chain Reaction (PCR) assay used to detect MAP, the initial development of which was recently completed by Quest Diagnostics. An appropriate regulatory path for the validation and approval of the assay is currently being explored by the Company.

http://www.cnbc.com/id/100358771/Red...hn039s_Disease
02-16-2014, 03:20 PM   #82
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In September 2013 RedHill initiated a first Phase III clinical trial with RHB-104 for Crohn’s Disease in North America and Israel. A second Phase III trial, in Europe, is planned to commence in the first half of 2014.

RedHill further acquired an exclusive license from the University of Central Florida Research Foundation, Inc. to a patent-protected diagnostic test for the detection of MAP (Mycobacterium avium paratuberculosis) bacterium, and is developing the diagnostic test with Quest Diagnostics.

http://www.redhillbio.com/product-pipeline/rhb-104/
So there is a test for it, and a vaccine, different sides of the coin?
02-16-2014, 03:23 PM   #83
Igor_Passau
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as I was posted for the 1 phase of the clinical trial ( on the people) you need about 10 -20 volunteers. But we need the criteria like age, etc. and restriction
02-16-2014, 04:41 PM   #84
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So there is a test for it, and a vaccine, different sides of the coin?
RedHill have their own treatment aimed at MAP as well, it's the 3 pronged antibiotic treatment created by Dr Borody that you may have heard of. i was unaware of the RedHill diagnostic test though, it'd be interesting to know how it compares to the one being created by Dr Hermon-Taylor.

It seems RedHill is doing better in the way of funding etc though. It's really frustrating watching this all unfold - in a way I wish i wasn't even aware of all of this research, knowing that there are treatments in the process of being developed but having no access to them is useless to me right now. Even if they work, it will be years before we can have access to them.
02-16-2014, 04:43 PM   #85
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Have you heard of the online sites where you can sign up to be a trial? Kind of scary, but a great thing if you are suffering and this could save you.
02-17-2014, 04:55 AM   #86
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I got a reply from my Prof:

Me: This story (MAP vaccine) appeared in the press recently and is getting a lot of attention from Crohn’s sufferers in on-line forums. I believe I have spoken to you before about whether you thought MAP was the root cause of Crohn’s and you said no. Is that still your view?

Prof: Thanks. My view is unchanged (as is that of most other gastroenterologists), but would be more easily amplified by talking than by typing! If you'd like to give me a ring, I'd be happy to have a chat tomorrow. What we need to see are the results of a clinical trial......
02-17-2014, 06:03 PM   #87
AJC - Australia
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Some people have MAP and dont get Crohns…….so, his vaccine works towards allowing someone with Crohns to get their immune system making the 'hunter cells' that can go and kill the MAP bacteria. People with crohns have an odd immune response to the bacteria i guess, while healthy people don't?
02-17-2014, 06:35 PM   #88
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Some people have MAP and dont get Crohns…….so, his vaccine works towards allowing someone with Crohns to get their immune system making the 'hunter cells' that can go and kill the MAP bacteria. People with crohns have an odd immune response to the bacteria i guess, while healthy people don't?

No, according to Herman-Taylors new test ALL people with Crohns are infected with MAP. Previous tests just weren't effective enough. MAP is a difficult bacterium to test/cultivate.
02-17-2014, 10:07 PM   #89
AJC - Australia
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Sorry Electrichead….

read again…

some people have MAP, but dont get Crohns…..ie healthy people.

cheers
02-18-2014, 01:12 AM   #90
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The rational behind selective susceptibility comes from the immune deficiency present in people with crohn's disease. "We" have considerable deficiencies of the innate immune system which would leave us vulnerable to intracellular pathogens.

Healthy people have no issues clearing MAP from macrophages, people with crohn's disease do:
https://www.ecco-ibd.eu/publications...atients-2.html

(doesn't mean MAP is therefore directly involved in the disease, they find more MAP in some (not all) ppl with CD, and the reason is probably because people with CD have issues clearing the bacteria)

Personally I don't think everyone with CD would have a MAP infection, simply because people with immune deficiencies tend to not all get the same infections. HIV patients are very susceptible to multiple different mycobacteria for example (interestingly, they have low rates of crohn's disease). I did get tested for MAP specifically with a DNA test and culture (which takes months and multiple reading over a time period of 3 then 6 months, then a year), which both turned out negative, but as ppl mentioned, tests are not accurate, and testing blood isn't as ideal as being able to test tissue.

The interest in MAP is justified I feel, because:
A: it's in the human food chain
B: it causes disease in many animals, including non-human primates
C: it's a mycobacteria and almost all mycobacteria cause disease

Last edited by kiny; 02-18-2014 at 01:43 AM.
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