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BioLineRX Announces Trial of New Celiac Drug

Celiac.com 01/31/2014 - Drug company BioLineRx has announced trials of BL-7010, a drug for treating celiac disease. BL-7010 is a new, non-absorbable, orally available polymer with a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease.

Image: Public Media--BioLineRXBL-7010 is intended to treat celiac disease by sequestering and effectively masking gliadins from enzymatic degradation and preventing the formation of immunogenic peptides that trigger the classic adverse immune reaction.

The BL-7010 is then excreted with gliadin from the digestive tract, preventing the absorption of gliadin into the blood.

The overall effect is to significantly reduce the immune response triggered by gluten. According to BioLineRX, pre-clinical studies have shown BL-7010 to be both safety and effective.

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BioLineRX's Phase 1/2 study is a two-part, both single and repeated, double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients.

The main goal is to gauge the safety of single and repeated increasing doses of BL-7010 in well-controlled celiac disease patients.

They also hope to assess the results of systemic exposure, if any, of BL-7010 in the study patients.

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6 Responses:

 
Jacqie
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
03 Feb 2014 4:45:21 PM PDT
Why in the world would I want to take a drug (which will definitely have side effects - they all do) to "treat" my celiac disease, when I have a proven, harmless, effective, inexpensive treatment already at my fingertips? I have no desire to EVER eat gluten again. I am perfectly happy being gluten free and I eat wholesome, delicious foods that nourish my body instead of destroying it. Recently, I was asked if I wanted to participate in clinical trials for a new "vaccine" for celiac disease. NO! Why would I take that kind of risk when I am already doing the best thing I can do for myself?

 
Kristen

said this on
04 Feb 2014 4:30:40 AM PDT
Why, you ask, Jacqie? Because this could change the lives of so many of us.

I know, for myself, this would not change my overall eating habits. I too am (mostly) happy with my current diet. I eat very well also, and was never a big bread person. The biggest loss for me was the dairy, but I've made my peace with it.

However, all that said I know there are a lot of people like me, who are so very limited in how they can function on a social level. For me, a cross-contamination event has a downtime of weeks to months. The pain and recovery are so intense and long lasting that eating out anywhere is simply not worth the risk. This is incredibly limiting. I cannot simply go out and order off the gluten free menu. There is no trust there. To get that freedom back, to be able to go (anywhere, vacations etc) with my spouse and not have to worry about how we are going to feed me, would be life changing. To order out and not worry about cross contamination. Amazing.
Yes, there will likely be side effects, but until we know more, I would not completely discount the idea.

 
Peggy Worley
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said this on
04 Feb 2014 6:48:45 AM PDT
I totally agree with you. When I first started "gluten free" it was really hard to do--now two years later I realize it's the way you are supposed to eat anyway!! Just go with fresh meat, fruits and veggies. I have kept my weight down to perfect for 2 years. I wouldn't change a thing.

 
Heather
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said this on
06 Feb 2014 10:09:21 AM PDT
I wouldn't want to participate in a trial, either. But, if the drug is eventually proven safe and effective and could be taken to eliminate cross-contamination risks (like when eating out), I'm all for it!

 
Gus
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said this on
17 Feb 2014 9:59:10 AM PDT
Because the gluten free diet is much more expensive than a regular diet there are so many people around the world with not enough economic resources to achieve a complete gluten free diet.

 
kwix
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said this on
04 Feb 2014 5:57:49 AM PDT
I have a very different opinion than Jacqie above. I spent the first 50 years of my life avoiding bread, pasta and such...anyway, I have no desire to ever eat that stuff again.

But I long for a time I can just eat out with others without poring over every detail of a menu and interrogating waiters for ten minutes. Or get some occasional Chinese carry-out. Or travel without constant planning, worrying and a carry-on full of GF food. Or just walk into any hole-in the wall ethnic restaurant and order something (obviously non-wheaty) I've never heard of, like I used to when I was a food blogger...




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The reason they set the limit at 20ppms is that through scientific study, they have proven that the vast majority of people with Celiac Disease do not have an autoimmune reaction to amounts below that......it is a safe limit for most. Also, just because that limit is set at 20ppms, does not mean that gluten-free products contain that amount of gluten. Testing for lower levels becomes more expensive with each increment down closer to 0-5ppms, which translates into higher priced products. Unless you eat a lot of processed gluten-free food, which can have a cumulative affect for some, most people do well with the 20ppm limit.

I'm in the Houston area so I'm assuming there are plenty of specialists around, though finding one that accepts my insurance might be hard. This might sound dumb, but do I search for a celiac specialist?? I'm so new to this and want to feel confident in what is/isn't wrong with my daughter. I'm with you on trusting the specialist to know the current research.

Hi VB Thats sounds like a good plan. Would it help to know that a frustrating experience in seeking diagnosis isn't unusual With your IGG result I'm sure a part of you is still wondering if they are right to exclude celiac. I know just how you feel as I too had a negative biopsy, but by then a gluten challenge had already established how severely it affected me. So I was convinced I would be found to be celiac and in a funny way disappointed not to get the 'official' stamp of approval. Testing isnt perfect, you've already learned of the incomplete celiac tests offered by some organisations and the biopsy itself can only see so much. If you react positively to the gluten free diet it may mean you're celiac but not yet showing damage in a place they've checked, or it may be that you're non celiac gluten sensitive, which is a label that for a different but perhaps related condition which has only recently been recognised and for which research is still very much underway. We may not be able to say which but the good news is all of your symptoms: were also mine and they all resolved with the gluten free diet. So don't despair, you may still have found your answer, it just may be a bit wordier than celiac! Keep a journal when you're on the diet, it may help you track down your own answers. Best of luck!

Run to the nearest celiac disease specialty center if you can. Especially with conflicting doc opinions. Where do you live? Honestly, I test positive to only the DGP and the newest research on its specificity is a mixed bag. My recent scope did not show "active" celiac disease but only a slight increase in IELs. I am waiting for my post biopsy appointment with the Celiac specialist next month. But I've been through a couple of GI'S locally and honestly I feel it was definitely worth going to a specialist. Especially when you have some positive blood work but a normal biopsy the doctors really go back and Forth on diagnosis and never really know for certain. Unfortunately given the above I just said I probably still do not know for certain. Sigh. But I trust the specialist to be at the top of his game on the research and at least I can feel confident and comfortable in what his opinion may be next month.

That's a great list with such great info! Do you eat at Shucks?