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Possible Celiac Disease Drug Treatment ALV003 Fast Tracked by FDA

Celiac.com 10/15/2012 - The drug ALV003, a potentially promising treatment celiac disease, made by Alvine Pharmaceuticals, Inc., has received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Photo: Jefferson AdamsALV003 is an orally administered mix of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP).

ALV003 works by targeting gluten and breaking it down into tiny fragments, which, in tests has been show to greatly reduce its ability to trigger immune responded in people with celiac disease. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development.

The Fast Track status is important for ALV003, because there are currently no approved therapeutic treatment options available to patients and their physicians," said Abhay Joshi, Ph.D., Alvine's President and Chief Executive Officer.

Fast Track is part of the FDA Modernization Act, passed in 1997. It is designed to streamline the development and review of drugs that treat serious or life-threatening conditions, and which address unmet medical needs.

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20 Responses:

 
Donnie
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said this on
15 Oct 2012 11:21:16 AM PST
I won't be a lab rat for this fast tracked drug. I will stay on my gluten free diet without taking it. Obviously, people who do take the drug will still have to eat gluten free, so why take a risk on having adverse reactions to it. Recombinent sounds like it might be genetically engineered, too. I really do hope the new drug is safe and effective. I will wait a few years, and see how other people who take the drug fare with it. Then decide if I want to try it myself.

 
Lori
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said this on
22 Oct 2012 7:30:34 PM PST
Same approach I've chosen to take with the gluten-free oats. I would still prefer to maintain a gluten-free diet, than contend with 'side effects' of a drug. That's the elegance of treating a disease by removing something, rather than adding complications by taking drugs.

 
David
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said this on
15 Oct 2012 6:25:41 PM PST
Sounds like it may help at least with those of us who are highly sensitive, and react to slight cross-contamination. It's almost impossible to eliminate gluten completely, even by eating only foods labelled gluten-free.

 
Edgar Dq
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said this on
16 Oct 2012 7:59:10 AM PST
Totally agree!

 
Christina
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said this on
22 Oct 2012 7:15:29 AM PST
Very interesting that this drug is on the fast track. I feel as though people will be under the impression that they'll be able to eat gluten while taking it, but, what does the drug do for the long term effects of celiac disease? Does it work on all forms of gluten intolerance? If not, the testing, screening, and diagnosing of different forms of gluten intolerance must be refined. I have been on a 100% gluten-free diet for 4 years now and I am in the best health that I have ever been in. After much research and reading I have come to my own opinions about gluten and feel as though my body was not designed to ingest it. That said, if a drug ever did exist that would allow me to eat gluten with no consequences whatever, I would probably not take it. I think the FDA is ahead of themselves: there are other aspects of gluten intolerance that must be refined before we start to manufacture drugs.

 
lvm
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said this on
22 Oct 2012 6:03:50 PM PST
Why must we refine other aspects of gluten intolerance? This is a potential treatment for celiac disease. The article plainly says "in conjunction with a gluten-free diet". Seeing as you wouldn't utilize a medication that would enable you to live a normal life even if there were no consequences whatsoever, why discourage others who want to?

 
Lori
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said this on
22 Oct 2012 7:44:05 PM PST
My thoughts exactly. The good side of this new 'drug'... there will be a huge increase in the diagnosing of this terribly under-diagnosed disorder. New tests to identify potential 'customers' !!

 
Johnnie Talley
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said this on
22 Oct 2012 8:03:28 AM PST
I too question taking medication when staying on a gluten-free diet. The recalls of medications after the damage is done happens too many times for me to risk my health on a basically unproven medication. The gluten-free diet is a healthy one and medication free.

 
Robert Geddes
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said this on
22 Oct 2012 12:11:10 PM PST
As a Coeliac, I can say from the look of the comments already posted - you all seem quite smug that you manage to stay on 100% gluten-free diets at all times. I strive to stay 100% gluten-free as well - but do sometimes have to eat outside the safety of my own house and surrender food preparation to others that don't take gluten-free as seriously or just plain don't understand.

If someone can produce a drug that can help with an accidental contamination, especially when away from my 'safe place', then I for one will gladly take it.

 
Cindy
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said this on
22 Oct 2012 3:59:22 PM PST
I would love to have something to help me when I am out and away from home. Yes, I totally agree.

 
Frances
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said this on
22 Oct 2012 7:17:50 PM PST
I agree with you. No need for people to act condescending about their choice. My son has celiac disease and myasthenia Ggravis. It's important for us to keep him 100% gluten-free but it is also just as important to let him be a kid! We have well meaning friends that make accommodations for him and at birthday parties, etc. they make gluten-free cupcakes, cookies, etc. just for him. I love it! However, I'm worried about cross contamination from utensils, non certified foods, etc. I have even seen my mother in law excitedly preparing my son some gluten-free garlic bread but I had to explain that we would have to redo it with a clean pan and spatula because she had used them right before for regular bread. In cases like this, when we can't be 100% positive that our food is gluten-free then it would be a godsend to have a medication as back up!

 
Lori
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said this on
22 Oct 2012 7:41:23 PM PST
There are some over the counter enzymes you can take that target the gluten. You might want to look into taking those when you eat out. That's what we do, and we are all highly sensitive (3 of us).

 
Sharon
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said this on
22 Oct 2012 8:39:47 PM PST
I agree. It is very easy to accidentally consume gluten. More detail in the article about exactly how this is supposed to work would be good. Is it to be taken after accidental known or suspected exposure, or all the time?

 
Jeff Cutler
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said this on
30 Oct 2012 6:05:46 PM PST
Robert, I completely agree with everything you said. I strive to stay on a 100% gluten-free diet but it is almost impossible because others just don't understand it. It's not like your meal is being watched every single second from when it starts to when it gets to your table. If there is a pill that will help with the effects of cross-contamination, I certainly welcome it.

 
Jamie
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said this on
21 Feb 2013 11:53:34 AM PST
Totally agree with you there... In conjunction with a gluten-free diet, it would greatly help those of us who occasionally get glutened by household members who just don't understand cross contamination even though you tell them a billion times not to use your butter for their toast. It would be a HUGE help when travelling or having to eat out in public when you can't be 100% sure that what you are getting is truly gluten-free.

 
Derya
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said this on
22 Oct 2012 6:57:13 PM PST
I was recently diagnosed with celiac disease. I am having a hard time trying to figure out what to eat. I ate at a lot of restaurants and now have trouble picking the right ones that are actually 100% gluten-free. So yes, I will take this pill only when I eat outside to protect myself and not on a daily basis.

 
Efrat
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said this on
23 Oct 2012 12:46:20 AM PST
Isn't the whole point of taking a drug so that you can EAT gluten again? What's the point if I still need to keep the diet??

 
Irv
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said this on
24 Oct 2012 4:44:47 AM PST
Think twice, act once. Let's watch first, this drug might be all it claims to be, then again...

 
Cindy Purdy
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said this on
24 Oct 2012 11:25:06 AM PST
I participated in a clinical trial 5 years ago for a drug Alba was developing on the "fast track." It's STILL in trials, so the fast track is really not that fast.

 
Marsha
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said this on
28 Oct 2013 9:48:27 PM PST
Always GF but know I am fooling myself thinking that some exposure is not there. Just have one awful attack of ingestion and ask yourself after much suffering if it is not a God Send for us celiacs to have something to help us along the journey and for goodness sakes, all, be happy that a drug company is looking into this no matter why. I am sick of those surprise attacks and the suffering and pain it brings. And to ignore anything that may be offered to us suffers for relief...WHY? After 18 years of knowing, yes, finally knowing what my problem was upon diagnosis - I have to look back at the years and remember a time when looking for gluten-free food was a big problem, period! Now we have so many wonderful products to help us along but they are allowed to put in a small amount of gluten and sometimes it can get yah, you know what I mean? I love progress and look forward for what the future will hold for our celiac condition.




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