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


 
06-06-2016, 04:46 PM   #841
JMC
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That's great JMC - thank you! Are you involved in the process? Is it still looking good for July testing? I worked in a lab for 3 years as a biochemist - if I lived there, I would volunteer like its nobody's business!
I am one of the people listed here: http://crohnsmapvaccine.com/about/team/

Regular update are available through the news letters which are here or via subscribing:
http://crohnsmapvaccine.com/category/news/newsletters/

I believe the vaccine trial has been delayed by a manufacturing hiccup at IDT in Germany, but the impact will only be clear when the timeline is updated.
06-06-2016, 05:10 PM   #842
Scared1
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I am one of the people listed here: http://crohnsmapvaccine.com/about/team/

Regular update are available through the news letters which are here or via subscribing:
http://crohnsmapvaccine.com/category/news/newsletters/

I believe the vaccine trial has been delayed by a manufacturing hiccup at IDT in Germany, but the impact will only be clear when the timeline is updated.
Oh that's so great you are a part of it! Is the hiccup going to cause a major delay? Thank you - and I do subscribe to the newsletters:-)
06-06-2016, 08:21 PM   #843
xeridea
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I am one of the people listed here: http://crohnsmapvaccine.com/about/team/

Regular update are available through the news letters which are here or via subscribing:
http://crohnsmapvaccine.com/category/news/newsletters/

I believe the vaccine trial has been delayed by a manufacturing hiccup at IDT in Germany, but the impact will only be clear when the timeline is updated.
Ooh, bummer! Hopefully they'll resolve the manufacturing hiccup soon.

Does this mean that they've moved manufacturing from Jenner Institute? I thought that's where the vaccine was being produced for the trial.
06-06-2016, 08:34 PM   #844
Scared1
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Ooh, bummer! Hopefully they'll resolve the manufacturing hiccup soon.

Does this mean that they've moved manufacturing from Jenner Institute? I thought that's where the vaccine was being produced for the trial.
Good point! I haven't thought of that - I looked up IDT:
IDT Biologika is a German biopharmaceutical company with headquarters in Dessau-Rosslau. It develops and produces biotechnology-based vaccines and pharmaceuticals.

So are they the new producers as opposed to Jenner institute? Do you know JMC why they changed it by any chance?
06-06-2016, 08:36 PM   #845
Scared1
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Actually - just saw this might answer the question, it was always noted that it was produced by HAV Vaccines from when I started checking this a few months back, and here is an excerpt of their website:
News

JANUARY 2016

Share subscriptions reach 1.5 million
HVL has now raised a total of 1.5 million of subscription monies for new shares in HVL and has issued the relevant shares.

GMP manufacture

GMP manufacture of HVLs priming vector ChAdOx2 HAV began in November 2015 at the Clinical BioManufacturing Facility at Oxford University.

GMP manufacture of HVLs boost vector MVA HAV began in January 2016 at IDT Biologika GmbH in Germany. .
06-07-2016, 04:37 AM   #846
JMC
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GMP manufacture of HVLs boost vector MVA HAV began in January 2016 at IDT Biologika GmbH in Germany. .
I believe the above is incorrect, manufacture did not start until April 2016 due to IDT being oversubscribed.
06-07-2016, 05:30 PM   #847
Scared1
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I believe the above is incorrect, manufacture did not start until April 2016 due to IDT being oversubscribed.
Oh I see - so that would push the timeline then.

Thank you JMC - please keep us posted:-)
06-13-2016, 04:40 PM   #848
Scared1
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these new developments are really encouraging... wish Dr Taylor all the best for the new MAP TESTing tests
Hi Sid,
I was looking at your signature - you have been in remission since diagnosis without meds?
06-14-2016, 11:37 AM   #849
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Hi Sid,
I was looking at your signature - you have been in remission since diagnosis without meds?
Hi,

Even before I was offically diagnosed with Crohns,,when the symptoms first appeared, I visited a an Ayurvedic doctor who diagnosed it as 'Grahani Rog' (its a Sanskrit term for Crohns/Colitis). The gentleman told me in clear words that going forward, food and lifestyle was my only medicine for life. Though he prescribed me meds and general Ayurvedic guidelines for my diet. I just followed the diet plan but didnt take the aurvedic medicines as I was always worried about side effects. Later when I was dignosed with Crohns disease after biopsy at a modern clinic, I was prescribed Pentasa. I continued Pentasa for a month and stopped, primarily because the medicines were expensive and also because my condition already started improving due to diet and lifestyle changes. That was the only time I took any medicines for Crohns.

I did follow few things though, especially that I learnt from this great forum. Like taking my Vit D and B12 shots though I have not taken B12 for months now and still its sufficient as per my last two tests. The only symptom that I continue to get is the gas formation But that I guess is not limited to only us Crohnnies.
__________________
In remission since Diagnosis

Crohn's since Jan 2011.

No meds.
Diet as per ayurveda.
Vitamin D and B12 shots.
Currently experimenting with Probiotics, starting 2016.
And a large joint mad family, thus stress cant touch me.
06-14-2016, 01:29 PM   #850
Scared1
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Hi Sid,
That is very interesting - if you don't me asking, have you had a scope at all to check how things are progressing? What kind of diet did the doctor put you on that has helped?
06-15-2016, 10:57 AM   #851
sid
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Hi Sid,
That is very interesting - if you don't me asking, have you had a scope at all to check how things are progressing? What kind of diet did the doctor put you on that has helped?
The last colonoscopy in 2015 had showed no signs of Crohns. The biopsy was not done. No inflammation detected through blood work either. I plan to go for a colonoscopy by the end of this year or may be the beginning of next year where I will also ask to get a biopsy done. The diet plan consisted of mainly select vegetable (and avoiding many of them), fruits, Morning intakes of curd, Avoiding non veg totally including eggs (although I cheated sometimes, but no red meat at all), I also stuck to khichdi, which is a special Indian preparation of rice and lentils for two weeks at a stretch then slowed down to once a week. apart from this changes in time and quantity of food intake and avoiding certain food after sunset, for example curd, etc. I keep following it even today though I cheat sometimes with chicken but I know my limits. The list of changes is long,,will PM you if you want..I think it would be inappropriate to hijack this lovely thread.
06-16-2016, 08:29 PM   #852
Scared1
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The last colonoscopy in 2015 had showed no signs of Crohns. The biopsy was not done. No inflammation detected through blood work either. I plan to go for a colonoscopy by the end of this year or may be the beginning of next year where I will also ask to get a biopsy done. The diet plan consisted of mainly select vegetable (and avoiding many of them), fruits, Morning intakes of curd, Avoiding non veg totally including eggs (although I cheated sometimes, but no red meat at all), I also stuck to khichdi, which is a special Indian preparation of rice and lentils for two weeks at a stretch then slowed down to once a week. apart from this changes in time and quantity of food intake and avoiding certain food after sunset, for example curd, etc. I keep following it even today though I cheat sometimes with chicken but I know my limits. The list of changes is long,,will PM you if you want..I think it would be inappropriate to hijack this lovely thread.
Thanks - that is very interesting! Yes, if you can please PM me details, I would like to encourage my husband to follow this if possible!
08-02-2016, 09:21 PM   #853
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Super late to this forum .... Is anyone on Stellara? I am suppose to go see a doctor this month that can get me approved through insurance for the med. just curious how many people are already trying it.
08-07-2016, 04:42 PM   #854
Scared1
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Nice article - talks about dysbiosis seen in MAP infected cows. I wonder if they can look at the dysbiosis seen and compare to see if there is a similar "pattern" seen in human's by comparing each profile?

http://www.ncbi.nlm.nih.gov/pubmed/27494144

Abstract:
PLoS One. 2016 Aug 5;11(8):e0160353. doi: 10.1371/journal.pone.0160353.
Dysbiosis of the Fecal Microbiota in Cattle Infected with Mycobacterium avium subsp. paratuberculosis.
Fecteau ME1, Pitta DW1, Vecchiarelli B1, Indugu N1, Kumar S1, Gallagher SC1, Fyock TL1, Sweeney RW1.
Author information
Abstract
Johne's disease (JD) is a chronic, intestinal infection of cattle, caused by Mycobacterium avium subsp. paratuberculosis (MAP). It results in granulomatous inflammation of the intestinal lining, leading to malabsorption, diarrhea, and weight loss. Crohn's disease (CD), a chronic, inflammatory gastrointestinal disease of humans, has many clinical and pathologic similarities to JD. Dysbiosis of the enteric microbiota has been demonstrated in CD patients. It is speculated that this dysbiosis may contribute to the intestinal inflammation observed in those patients. The purpose of this study was to investigate the diversity patterns of fecal bacterial populations in cattle infected with MAP, compared to those of uninfected control cattle, using phylogenomic analysis. Fecal samples were selected to include samples from 20 MAP-positive cows; 25 MAP-negative herdmates; and 25 MAP-negative cows from a MAP-free herd. The genomic DNA was extracted; PCR amplified sequenced on a 454 Roche platform, and analyzed using QIIME. Approximately 199,077 reads were analyzed from 70 bacterial communities (average of 2,843 reads/sample). The composition of bacterial communities differed between the 3 treatment groups (P < 0.001; Permanova test). Taxonomic assignment of the operational taxonomic units (OTUs) identified 17 bacterial phyla across all samples. Bacteroidetes and Firmicutes constituted more than 95% of the bacterial population in the negative and exposed groups. In the positive group, lineages of Actinobacteria and Proteobacteria increased and those of Bacteroidetes and Firmicutes decreased (P < 0.001). Actinobacteria was highly abundant (30% of the total bacteria) in the positive group compared to exposed and negative groups (0.1-0.2%). Notably, the genus Arthrobacter was found to predominate Actinobacteria in the positive group. This study indicates that MAP-infected cattle have a different composition of their fecal microbiota than MAP-negative cattle.
08-25-2016, 08:15 PM   #855
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Hi everyone! I'm new to the forum (and newly diagnosed) and trying to get my head around all the currently available and future treatment options for Crohns. As I read about meds in Phase II/III, I couldnt help but notice that more often than not promising drugs are bought by bigger pharmaceuticals or bio companies and I cant help but wonder: if anti-MAP or a MAP vaccine is a credible way forward in managing Crohns, why arent there any big pharmas working on this as well or attempting to buy the technology? At the very least, why isnt this getting market attention from the big players or other research groups around the globe? Thoughts?
08-25-2016, 08:59 PM   #856
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Julia - RedHill is a BioPharma doing a Stage 3 trial (which is almost done) on AMAT. Prior to RedHill, there was nothing to patent because the MAP theory uses generic drugs. Big Pharma wouldn't be interested, plus it would knock out their billions of immunosuppressants if Crohn's was shown to be pathogenic.

Also, the MAP theory could never be conclusively proven because the diagnostic techniques were not available. But now there are labs working on these successfully, and I'm guessing down the road a lot more companies are going to either offer to purchase these smaller, successful ones (like Otakaro) or begin their own R&D on these methods. RedHill is the key. Once AMAT is approved by the FDA for the treatment of CD, companies will jump in. I've noticed that in the veterinary sector, there is a huge interest in techniques and diagnostics to deal with MAP in food and cattle. Even Nestle jumped in with a new method to purify their infant formula.

I'm sorry you have CD. It's a rocky road sometimes, but you got it at the perfect time, when the science is blowing wide open. Hopefully you won't have the decades of stories like many of us, and your case can be managed to give you the best quality of life. And who knows, I've never given up hope for a cure, and the new research really makes me think that I'll see it in my lifetime. I hope you are well, and please reach out if you need anything.
__________________
Currently on: Anti-MAP therapy and loving life! Full remission since Jan 2015. Clarithromycin, rifampin and low dose naltrexone. (Levofloxicin had too many side effects so discontinued after 5 months.) Resources on human MAP and Crohn's here: HumanPara.org.

Past (failed) Treatments: Remicade, Humira, Prednisone, Pentasa, Azulfadine, Lialda, No gluten/dairy/sugar/coffee or processed food in general. Flagyl worked but not long term.
09-02-2016, 11:52 AM   #857
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Any news on the MAP vaccine?
09-02-2016, 04:21 PM   #858
xeridea
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Any news on the MAP vaccine?
The source: http://crohnsmapvaccine.com/news/

But last I heard Phase 1 trials pushed back to end of this year. If that goes well, phase 2 usually follows 18 months later. And if good results there, there will be big cash infusion to catapult into phase 3. If all goes well, maybe something to general patient population in 2020 timeframe?
09-07-2016, 08:47 PM   #859
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Any news on the MAP vaccine?
I want to revise my estimate to mid-2020's at earliest for when I think the vaccine might become available as I have thought about this some more.

There has been some recent research in immuno-oncology that uses a heat-killed whole cell Mycobacterium vaccine to augment pancreatic cancer treatment. This vaccine is used to fire up the immune system (T-Cells) to augment the effects of a chemotherapy drug targeting pancreatic cancer.

The company behind it, Immodulon Therapeutics, is also a UK company. From 2010-2015, their cash position ranged from 2M-5Million, likely sufficient to comfortably fund clinical trials.

They started and completed their Phase 1 (safety) trial in 2010. They then went on to Phase 2 in 2011, and though wrapped up in 2015, are still working on final results. Work is being done on initiating Phase 3 but nothing yet. The upshot is that Phase 1 and 2 took about 6 years to complete. Phase 3 may tack on another 3 or 4 years to process, so a decade from the start of Phase 1 to completion of Phase 3 is not unfathomable.

So if MAP Vaccine goes into trials end of this year, and all the data between now and the end of phase 2 trials show promise, then a vaccine may become available by mid-2020s.

The wrench in the works though is at what pace and with what vigor can development continue to be driven forward? Prof. Hermon-Taylor's bio says he became a doctor in 1960. Wikipedia says it takes 7-9 years to become a doctor in the UK. So it's likely he was 25-30 years old at the time. Fast-forward 56 years to today, that puts the professor at about 80 Y.O. Though I'm sure the professor is as healthy as an ox, he is getting up there in years. And how well is their effort funded? They continue to push for crowd-funding their efforts, though I know the entity that owns the intellectual rights to the vaccine may have more capital at hand.

Back in 2013 when I learned about the MAP vaccine I was a much bigger cheerleader of their efforts. As time passes, I have gained a better appreciation for the difficulties of drug development and am scaling back my expectations.
09-17-2016, 04:35 PM   #860
Julia S
 
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Yea, reading about some of the biologics and other medications used for Crohns, it seems it usually takes 10 years between initial assessment and the drug hitting the market. And, in any case, we really have no idea if the vaccine will actually work It's frustrating to think that we might need to wait a couple more years just to find out if the vaccine is effective or not in humans. ...Sigh..
10-05-2016, 04:28 PM   #861
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https://penncurrent.upenn.edu/resear...rohn-s-disease
10-06-2016, 09:52 AM   #862
MarkB
 
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Any news on the MAP vaccine?
Some updates in this newsletter: http://thecrohnsinfection.org/the-ma...-october-2016/

In addition to the vaccine updates, there's other great reading on new Crohn's research.
10-06-2016, 12:04 PM   #863
Scared1
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Exciting stuff!
http://www.econotimes.com/RedHill-Bi...Q2-2017-336024
10-06-2016, 02:13 PM   #864
Julia S
 
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Any update on the phase I trials for the vaccine, JMC?

As for the redhill news, I'm not sure if it's good or bad news that interim results will now only be released in Q2 2017...
10-07-2016, 08:13 AM   #865
Scared1
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Any update on the phase I trials for the vaccine, JMC?

As for the redhill news, I'm not sure if it's good or bad news that interim results will now only be released in Q2 2017...
Hi Julia,
On the contrary - very good news if you tuned into their webcast (I did). By increasing their length of the trial - they are able to show greater efficiency because they have a larger sample size, and they are introducing an early stop process for very success results as an option. The interim results are very good and a new paper was published:

"A single capsule formulation of RHB-104 demonstrates higher anti-microbial growth potency for effective treatment of Crohns disease associated with Mycobacterium avium subspecies paratuberculosis"
10-07-2016, 08:59 AM   #866
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Thanks for the update Scared1. Did they say anything about the current trial? Around 200 people completed half the trial, correct? Was anything mentioned about their progress?
10-07-2016, 09:55 AM   #867
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Replay of RHB's webcast is available here: http://edge.media-server.com/m/p/mfnetkpw You can enter any name and email in the registration form in order to gain access to the replay.

The interim results are very good
But in both webcast (around 13:00 timestamp) and in their press-release from October 6 2016 ( http://ir.redhillbio.com/releasedeta...leaseID=992371 ) they state that "RedHill will remain blinded to the interim and ongoing results from the Phase III study". In webcast it was said "of course we'll remain blinded on results until independent interim analysis in q2 2017". So something is misunderstood.

a new paper was published:

"A single capsule formulation of RHB-104 demonstrates higher anti-microbial growth potency for effective treatment of Crohns disease associated with Mycobacterium avium subspecies paratuberculosis"
Link to the paper itself: http://gutpathogens.biomedcentral.co...099-016-0127-z

I don't understand why they are so arrogant to make statements about efficacy of RHB-104 in theatment of Crohn's Disease based solely on in vitro studies..

Did they say anything about the current trial? Around 200 people completed half the trial, correct? Was anything mentioned about their progress?
Progress of these 200 will be independently analyzed in q2 2017. In the case of overwhelming success study will be finished, otherwise recruitment will continue until the end of 2017 in order to recruit all four hundred something participants. So no info about progress until q2 2017.
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10-07-2016, 08:57 PM   #868
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I don't understand why they are so arrogant to make statements about efficacy of RHB-104 in theatment of Crohn's Disease based solely on in vitro studies..
The study you are referring to was not done by RedHill. A different lab used the RHB104 generic forumulation and tested it's effectiveness in vitro. They are not affiliated with RedHill. RedHill is still blinded.

It doesn't seem like RedHill is making arrogant statements to me. My guess is that of course RedHill thinks this is going to work though. They've had a positive Phase 2 study and keep in mind, this is the basic formulation that Prof. Borody's been using for years with success, and then it was licensed to RedHill for the Phase 3 trial.
10-11-2016, 08:11 AM   #869
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I don't understand why they are so arrogant to make statements about efficacy of RHB-104 in theatment of Crohn's Disease based solely on in vitro studies..
It's not arrogance so much as it is "selling the dream." Small biotech and pharma wannabes do it all the time. It's part of the way to keep the enthusiasm up and hopefully attract investors.

We just have to be patient. Eventually the data will tell the real story. Data always wins in the end.
10-11-2016, 08:16 AM   #870
Julia S
 
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I would still very much like to know what's going on with the vaccine.

Phase I trials were supposed to start earlier this year and were delayed due to a manufacturing pickup. Id love to know what's the current news on this as the website hasn't been updated in a while...
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