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    BioLineRx Clears Latest Hurdle for Celiac Treatment Drug


    Jefferson Adams
    Image Caption: Photo: Wikimedia Commons--CitrusZest

    Celiac.com 12/09/2014 - Biopharmaceutical company BioLineRx Ltd., has announced successful final results from its Phase 1/2 study for BL-7010, a novel co-polymer for the treatment of celiac disease.


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    Photo: Wikimedia Commons--CitrusZestBL-7010 is a new, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. The drug works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat.

    This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood.

    The trial results showed BL-7010 to be safe and well tolerated in both single- and repeated-doses, and pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples.

    The company has also settled on a one gram, three times per day regimen of BL-7010 as the optimal repeated dose for an upcoming randomized, placebo-controlled efficacy study set to begin in the last half of 2015.

    The absence of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe.


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    That's nice, however, I will not use it. Why should I pay to take a drug for the rest of my life just so I can eat gluten-containing foods which really aren't good for you anyway and cause more health problems. Sounds like a lose-lose situation to me.

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    Guest Carol August

    Posted

    Article worth the time/effort to read it. Perhaps a bit more thorough explanation of the chemistry of this new drug could be helpful to the lay person.

    Thank you.

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    Guest Angela Thompson

    Posted

    How long will it be before BL-7010 is approved by the FDA in the US? I need relief from the celiac symptoms. I am ultra sensitive even to a lot of the gluten free products. I have lost down to 112lbs. I weighed 122 almost 9 months ago.

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    Guest Phyllis Smoker

    Posted

    How long will it be before BL-7010 is approved by the FDA in the US? I need relief from the celiac symptoms. I am ultra sensitive even to a lot of the gluten free products. I have lost down to 112lbs. I weighed 122 almost 9 months ago.

    I also am sensitive to a lot of gluten-free foods. I have found out it is the mono and diglicerides that are used in manufacturing. Mono glicerides are OK, but eliminate foods with mono and diglicerides, see if that helps you. It has helped me.

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    That's nice, however, I will not use it. Why should I pay to take a drug for the rest of my life just so I can eat gluten-containing foods which really aren't good for you anyway and cause more health problems. Sounds like a lose-lose situation to me.

    Wrong! - every time you don't prepare everything you eat from scratch you risk a gluten exposure. The amount for a Coeliac reaction is so tiny (one breadcrumb) and the time to repair (6 to 12 months) so long this would help ensure you keep yourself safe. No matter how careful a Coeliac is - this is a very useful product. Cant wait...

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    Guest Wayne Boswell

    Posted

    I might be interested in such a drug, if it is performing a function that the normal (non-celiac) body performs. I've never read anything as to how the non-celiacs body handles gluten (gliadin). I did appreciate the comment on digicerides, and plan to attempt that. Still looking for answers 20 years after celiac diagnosis.

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    The celiac situation is so complex and there is so much that remains unknown. The danger with a drug to treat part of a problem doesn't allow intelligent consumer choices. For instance for a great many celiacs, the casein in dairy products causes similar symptoms. There is too great a similarity between the proteins in casein, corn even other grains originally thought to be safe for celiacs. So lets say you take a drug that handles gliadin and you think, "Great" now I can eat anything. Not really. You may take chances with wheat because of the drug and never know that you are causing damage because of the other proteins. You are also ingesting a chemical which needs years of trials and after market testing to show the real side effects. There is so much great whole food to eat, why stay so heavily focused on wheat induced happiness?

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    Guest Peter Olins

    Posted

    How long will it be before BL-7010 is approved by the FDA in the US? I need relief from the celiac symptoms. I am ultra sensitive even to a lot of the gluten free products. I have lost down to 112lbs. I weighed 122 almost 9 months ago.

    Hi Angela. This drug is still in the early stages of clinical development. The latest study was simply to test for safety at different doses, and to measure if the drug was absorbed by the body. It did not address whether the drug actually works. Sadly, a large majority of drugs that reach this stage of development never reach the market, due to safety or efficacy problems. In other words, while this work is exciting, we are still a long way from being able to celebrate.

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    Destiny Stone
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    Destiny Stone
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    Source:

    MedScape Today

    Diana Gitig Ph.D.
    Celiac.com 05/23/2011 - ImmusanT, Inc., a biotechnology start up based in Cambridge, Massachusetts, is testing a vaccine to desensitize celiac patients to gluten. It is called Nexvax2, and it has already passed Phase I clinical trials, which means that it is safe and tolerable to humans. Nexvax2 is slated to begin Phase II trials, which address efficacy, within the next year.
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    http://www.sciencedaily.com/releases/2011/05/110509091559.htm

    Tina Turbin
    Celiac.com 10/12/2011 - According to recent estimates, three million Americans suffer from celiac disease—approximately 1% of the population, and only three percent of them have to this writing been correctly diagnosed. As startling as that sounds to us all, according to a news article on Medscape Today, the incidence of celiac disease has increased markedly over the last three decades, perhaps even as fourfold, and studies are suggesting the incidence may actually be higher than 1% of the population.
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    Celiac.com 06/16/2018 - Summer is the time for chips and salsa. This fresh salsa recipe relies on cabbage, yes, cabbage, as a secret ingredient. The cabbage brings a delicious flavor and helps the salsa hold together nicely for scooping with your favorite chips. The result is a fresh, tasty salsa that goes great with guacamole.
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    Sources:
    1. Toft M, Dietrichs E. Aggravated stuttering following subthalamic deep brain stimulation in Parkinson’s disease--two cases. BMC Neurol. 2011 Apr 8;11:44.
    2. Tani T, Sakai Y. Stuttering after right cerebellar infarction: a case study. J Fluency Disord. 2010 Jun;35(2):141-5. Epub 2010 Mar 15.
    3. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    4. Jäncke L, Hänggi J, Steinmetz H. Morphological brain differences between adult stutterers and non-stutterers. BMC Neurol. 2004 Dec 10;4(1):23.
    5. Kell CA, Neumann K, von Kriegstein K, Posenenske C, von Gudenberg AW, Euler H, Giraud AL. How the brain repairs stuttering. Brain. 2009 Oct;132(Pt 10):2747-60. Epub 2009 Aug 26.
    6. Galantucci S, Tartaglia MC, Wilson SM, Henry ML, Filippi M, Agosta F, Dronkers NF, Henry RG, Ogar JM, Miller BL, Gorno-Tempini ML. White matter damage in primary progressive aphasias: a diffusion tensor tractography study. Brain. 2011 Jun 11.
    7. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    8. [No authors listed] Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 43-1988. A 52-year-old man with persistent watery diarrhea and aphasia. N Engl J Med. 1988 Oct 27;319(17):1139-48
    9. Molteni N, Bardella MT, Baldassarri AR, Bianchi PA. Celiac disease associated with epilepsy and intracranial calcifications: report of two patients. Am J Gastroenterol. 1988 Sep;83(9):992-4.
    10. http://ezinearticles.com/?Food-Allergy-and-Stuttering-Link&id=1235725 
    11. http://www.craig.copperleife.com/health/stuttering_allergies.htm 
    12. https://www.celiac.com/forums/topic/73362-any-help-is-appreciated/
    13. Ford RP. The gluten syndrome: a neurological disease. Med Hypotheses. 2009 Sep;73(3):438-40. Epub 2009 Apr 29.
    14. Hadjivassiliou M, Gibson A, Davies-Jones GA, Lobo AJ, Stephenson TJ, Milford-Ward A. Does cryptic gluten sensitivity play a part in neurological illness? Lancet. 1996 Feb 10;347(8998):369-71.

    Jefferson Adams
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    They also noted a higher frequency of surface CD3(−) IELs in cases with clonal TCR-GR, but the PCP pattern showed no associations with any clinical or pathological feature. 
    Repeat biopsy showed that the clonal or PCP pattern persisted for up to 2 years with no evidence of RCDII. The study indicates that better understanding of clonal T cell receptor gene rearrangements may help researchers improve refractory celiac diagnosis. 
    Source:
    Journal of Clinical Pathologyhttp://dx.doi.org/10.1136/jclinpath-2018-205023

    Jefferson Adams
    Celiac.com 06/13/2018 - There have been numerous reports that olmesartan, aka Benicar, seems to trigger sprue‐like enteropathy in many patients, but so far, studies have produced mixed results, and there really hasn’t been a rigorous study of the issue. A team of researchers recently set out to assess whether olmesartan is associated with a higher rate of enteropathy compared with other angiotensin II receptor blockers (ARBs).
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    To get solid data on the issue, the team conducted a cohort study among ARB initiators in 5 US claims databases covering numerous health insurers. They used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy. In all, they found nearly two million eligible patients. 
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    After PS matching comparing olmesartan to other ARBs, hazard ratios were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. Patients aged 65 years and older showed greater hazard ratios for celiac disease, as did patients receiving treatment for more than 1 year, and patients receiving higher cumulative olmesartan doses.
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    Source:
    Alimentary Pharmacology & Therapeutics

    Jefferson Adams
    Celiac.com 06/12/2018 - A life-long gluten-free diet is the only proven treatment for celiac disease. However, current methods for assessing gluten-free diet compliance are lack the sensitivity to detect occasional dietary transgressions that may cause gut mucosal damage. So, basically, there’s currently no good way to tell if celiac patients are suffering gut damage from low-level gluten contamination.
    A team of researchers recently set out to develop a method to determine gluten intake and monitor gluten-free dietary compliance in patients with celiac disease, and to determine its correlation with mucosal damage. The research team included ML Moreno, Á Cebolla, A Muñoz-Suano, C Carrillo-Carrion, I Comino, Á Pizarro, F León, A Rodríguez-Herrera, and C Sousa. They are variously affiliated with Facultad de Farmacia, Departamento de Microbiología y Parasitología, Universidad de Sevilla, Sevilla, Spain; Biomedal S.L., Sevilla, Spain; Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain; Celimmune, Bethesda, Maryland, USA; and the Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría, Sevilla, Spain.
    For their study, the team collected urine samples from 76 healthy subjects and 58 patients with celiac disease subjected to different gluten dietary conditions. To quantify gluten immunogenic peptides in solid-phase extracted urines, the team used a lateral flow test (LFT) with the highly sensitive and specific G12 monoclonal antibody for the most dominant GIPs and an LFT reader. 
    They detected GIPs in concentrated urines from healthy individuals previously subjected to gluten-free diet as early as 4-6 h after single gluten intake, and for 1-2 days afterward. The urine test showed gluten ingestion in about 50% of patients. Biopsy analysis showed that nearly 9 out of 10 celiac patients with no villous atrophy had no detectable GIP in urine, while all patients with quantifiable GIP in urine showed signs of gut damage.
    The ability to use GIP in urine to reveal gluten consumption will likely help lead to new and non-invasive methods for monitoring gluten-free diet compliance. The test is sensitive, specific and simple enough for clinical monitoring of celiac patients, as well as for basic and clinical research applications including drug development.
    Source:
    Gut. 2017 Feb;66(2):250-257.  doi: 10.1136/gutjnl-2015-310148.