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    Jefferson Adams 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 biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as 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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    Jefferson Adams
    Celiac.com 03/30/2012 - A company called Microtest Laboratories is manufacturing doses of what they claim may be the first effective vaccine treatment for celiac disease. At this point, the only treatment for celiac disease is to avoid gluten in the diet.
    Other companies are working on vaccines for celiac disease, and several working trials are underway. However, this new drug's creator, ImmusanT, based in Cambridge says that, unlike other vaccines, which prevent an infection, their drug, Nexvax2 works by changing the immune system so it no longer attacks gluten.
    Production on Nexvax2, began last week, Steven G. Richter, Microtest’s president and science director, told a local reporter. So far, ImmusanT has raised $20 million in investor capital to bring the vaccine to market.
    Regarding the path from concept to manufacturing for Nexvax2, Richter says that the process has been anything but straightforward. "It's arty process," he told a local reporter, "you have to develop protocols for all the manufacturing and plans to do all of the work aseptically. You have to get all those protocols and plans approved through the regulatory process. Then you have to do the work.”
    Microtest is initially manufacturing 9,000 vials for ImmusanT: two 3,000-dose batches of vaccine and a 3,000-dose batch of inert placebo to be used in the clinical trial. Richter says that the control group contains everything except the active vaccine.
    ImmusanT is looking to start the first clinical trials in the second quarter of this year by testing the doses on people with celiac disease. The full article, in Massliveonline.com quotes Leslie J. Williams, president and CEO of ImmusanT, as saying that “The test will be if it [the vaccine] induces a tolerance for gluten in the diet."
    The report says that Williams and the company hope to get the vaccine commercially available by 2017. Will the company succeed? Will they have a successful vaccine available in just five short years? Let us know what you think.


    Jefferson Adams
    Celiac.com 04/10/2015 - Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease. However, new drugs in development, some of which are currently being tested on humans, might allow people with celiac disease to safely eat gluten again, at least in small amounts.
    To be fair, even if all goes smoothly, it will be a few years at least before we see such treatments on the market. Moreover, even though many early results have been encouraging, none have yet entered safety trials, the final step before Food and Drug Administration approval and commercial availability.
    Drugs currently under trial include an enzyme that splits the protein in wheat that triggers adverse reactions, into smaller harmless products, and another which promises to make the gut less leaky, and thus block potentially toxic substances from triggering inflammation.
    There are several other drugs in earlier stages of development aimed at suppressing the immune response to gluten and preventing intestinal inflammation:
    ALV003, which will protect people with celiac disease against gut damage from small amounts of gluten. BL-7010 is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten. ImmusanT’s therapeutic vaccine Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Larazotide acetate (AT-1001) is Alba Therapeutics Corporation’s investigational product, a first-in-class tight junction regulator, intended for the treatment of patients with celiac disease. AVX176, from Avaxia Biologics, is an investigational oral antibody drug that is the subject of U.S. composition of matter patent 8,071,101, “Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance.” The patent, which expires on May 27 2029, provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia’s proprietary platform technology [32]. ActoGenX is carrying out discovery research in celiac disease with its range of ActoBiotics™, which use Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc. Chemocentryx’s CCR9, is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn’s disease. It has completed one Phase 2 trial in 67 patients with celiac disease. Meanwhile, in Europe, Dr. Falk Pharma and Zedira recently announced the start of phase I clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. The small molecule targets the dysregulated transglutaminase within the small intestine in order to dampen the immune response to gluten which drives the disease process.
    Some of these drugs may be taken right before eating gluten, while others might be more effective when taken on a regular schedule. If approved for use as intended, these drugs will likely allow people with celiac disease to eat gluten in small amounts. To my knowledge, there is no drug in current trial phases that is designed to permit unrestricted gluten consumption.
    So, the good news is that the next few years may see commercially available treatments that might actual help people manage celiac disease. The downside for people with celiac disease, at least for now, is that there is no treatment on the horizon that will allow safe, unlimited gluten-consumption. Moreover, there is no hint that a cure is coming anytime soon.
    Still, it’s good to know that researchers are working on providing helpful tools for treating celiac disease.
    Are you looking forward to seeing new treatment options for celiac disease? What kind of benefits should such treatments offer?
    Source:
    Gastroenterology Report

    Jefferson Adams
    Celiac.com 02/04/2016 - BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.
    This designation clears path for BioLine’s BL-7010 program, and allows the company to plan the next steps in the development of a commercial version of BL-7010.
    BL-7010 shows a high affinity for gliadins, the proteins in gluten that trigger celiac disease. BL-710 works by sequestering gliadins, effectively masking them from enzymatic breakdown, and blocks the formation of immunogenic peptides that trigger the adverse immune reactions in people with celiac disease. This results in a significantly reduced immune response triggered by gluten. Together with the gluten, BL-7010 passes harmlessly through the digestive tract and is not absorbed into the blood.
    The safety and efficacy of BL-7010 have been demonstrated in a number of pre-clinical studies, including a Phase 1/2 study completed in November 2014.
    In prepared comments, BioLineRX CEO Kinneret Savitsky, Ph.D., said that the company is "excited to receive confirmation for the medical device designation pathway in Europe for our BL-7010 program," and is now planning the next steps in the development of this product, including the next clinical efficacy study which we expect to commence in mid-2016."
    The company also continues to "evaluate the potential of BL-7010 as a food supplement," said Dr. Savitsky.
    Read more at: PRNewswire.

    Jefferson Adams
    Celiac.com 07/19/2016 - The world's first vaccine aimed at curing celiac disease is slated to begin full trials later this year, and residents of the Australian state of Victoria will be among the first humans to give it a try against celiac disease.
    The vaccine, called Nexvax2, was developed by Australian scientist Dr Bob Anderson, and is aimed at giving celiac patients a chance to overcome their immune reaction to the gluten found in products containing wheat, rye and barley. Nexvax2 aims to de-sensitise patients to three peptides contained in gluten that trigger a damaging reaction in their immune system.
    Previous trials on 150 patients from Melbourne, Perth, Adelaide, Brisbane and Auckland were aimed at finding a safe dosage rather than assessing its ability to beat celiac disease. Results from those favorable earlier trials were released in May, and Dr Anderson says that the larger phase II study, also being undertaken in the US and Europe, will assess how well the vaccine works against celiac disease.
    Dr Anderson first identified the peptides triggering coeliac disease and began developing the vaccine while working at Melbourne's Walter and Eliza Hall Institute, before travelling to Boston for six weeks as part of a sister city arrangement through the City of Melbourne, where he made contact with ImmusanT to further the discovery.
    This is certainly exciting news for people with celiac disease, many of whom may benefit from such treatment.
    Stay tuned for news on the progress of these trials.
    Source:
    dailysecrets.press

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