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  • Jefferson Adams
    Jefferson Adams

    Possible Celiac Disease Drug Treatment ALV003 Fast Tracked by FDA

    Reviewed and edited by a celiac disease expert.

    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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    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.

    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' !!

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    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.

    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?

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    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.

    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.

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    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.

    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.

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    Always gluten-free 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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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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