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Jefferson Adams posted an article in Celiac Disease Diagnosis, Testing & TreatmentCeliac.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.
Gryphon Myers posted an article in Additional Celiac Disease ConcernsCeliac.com 05/23/2012 - In April 2012, the National Foundation for Celiac Awareness debuted its Tiered Credentialing system, whereby restaurants can be awarded varying levels of a gluten-free designation. The system has spawned much controversy, as many sufferers of celiac disease argue that there should be no flexibility with the gluten-free term. Many argue that a food either contains gluten, or it does not: leading people to believe gluten-contaminated products are gluten-free could be harmful to celiacs. The issue came to a head when the NFCA awarded Domino's 'gluten-free pizza with an 'amber' gluten-free designation. The controversy is in the preparation: while Domino's may use gluten-free ingredients to make the crust, no extra effort is put forth to avoid contamination (hence, their 'amber' credential rather than 'green', which would be awarded to restaurants who take more care to avoid gluten contamination). Such contamination is almost assured given the volume of gluten flour present in a typical pizza restaurant kitchen, so many have argued that an 'amber' designation is really only useful to people who are gluten-conscious, but do not suffer from any form of gluten sensitivity. A number of celiac disease experts have come forth to denounce Domino's crust and the NFCA's endorsement of it. The NASSCD has even gone so far as to accuse Domino's of “exploitation”, given the gluten-free diet's recent surge in popularity. Domino's or the NFCA might argue that their crust was never intended for those with celiac disease, and that the 'amber' designation indicates that, but as Dr. Steven Guanalini, president of NASSCD argues,“there should be no need for disclaimers. The threshold has to be set at the same level for everybody for the term gluten-free to be meaninful.” In what may be viewed as something of a victory for the celiac community, the NFCA announced that in response to overwhelming public pressure, it is suspending use of its “amber” credential. According to their press release, they will "conduct a review to determine the most effective and clearest way to warn the community of the risk of cross-contamination and the use of the phrase 'Gluten Free'". It is still unclear what this means for Domino's. Sources: http://nrn.com/article/dominos-under-fire-labeling-crust-gluten-free?page=0,0 http://www.celiaccentral.org/nfca-statement-7937/
Celiac.com 10/28/2005 - Alba Therapeutics Corporation (Alba) today announced successful completion of its first Phase I trial for the drug candidate AT-1001, and that the FDA has granted Fast Track designation to AT-1001 for treatment of celiac disease. We are pleased to have concluded our first human study of oral AT-1001 and delighted that the FDA has granted fast track status to AT-1001. These two events are important additional milestones in our efforts to help those suffering from celiac disease, a disease for which there is no effective treatment, said Blake Paterson, MD, President and CEO of Alba. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001 in celiac patients within the next few months. Fast track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting Accelerated Approval. About Celiac Disease Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in common food grains such as wheat, rye and barley. According to the NIH, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Zonulin Zonulin is an endogenous signaling protein that transiently and reversibly opens the tight junctions (tj) between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Discovered by Alba co-founder Dr. Alessio Fasano, zonulin appears to be involved in many disease states in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of auto-immune diseases. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to commercializing disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway. Albas lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes. Contact: Dr. Blake Paterson Alba Therapeutics Corporation 410-522-8708