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Celiac.com 08/21/2015 - Here's every celiac disease treatment currently in development in a single list: ALV003, by Alvine Pharmaceuticals, is a combination of two enzymes that break down gluten before it can provoke an immune reaction. The drug is a powder to be dissolved in water and taken before meals. ALV003 most recently passed a phase 2 clinical trial, results of which appeared in the June 2014 issue of Gastroenterology. Post-trial biopsies showed that ALV003 prevented intestinal damage in 34 volunteers with celiac disease who ate 2 grams of gluten each day for six weeks and also took the drug. Phase 2b, a 12-week trial, is now underway. AN-PEP, by DSM Food Specialties, is another enzyme that degrades gluten. AN-PEP is believed to work best when taken while gluten is still in the stomach. Results from a small 2013 study showing AN-PEP to be safe, appeared in the World Journal of Gastroenterology. For the study, 16 people ate 7 grams of gluten every day for two weeks and half of them also ate AN-PEP, and half took a placebo. However, the placebo group did not get sick enough during the course of the study to show that the enzyme had any effect, so further study is under way. ActoBiotics by ActoGenX uses Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc. Early pre-clinical work with a genetically altered L. lactis secreting a peptide derived from gliadin demonstrated an in vivo suppression of gluten sensitization. Specifically, Huigbregtse et al. engineered L. lactis to secrete a deamidated DQ8 gliadin epitope (LL-eDQ8d) and studied the induction of Ag-specific tolerance in NOD ABo DQ8 transgenic mice . Although apparently not part of the ActoGenX development program, recent work by Galipeau et al. also deserves mention in this context. The group treated gluten-sensitive mice with elafin, a serine protease inhibitor, delivered by the L. lactis vector, and found normalization of inflammation, improved permeability, and maintained ZO-1 expression. There is speculation that this is due to reduced deamidation of gliadin peptide. AVX176 by Avaxia Biologics, is an investigational oral antibody drug patented to provide "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. BL-7010, by BioLineRx, is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten. This drug has been shown in mice to reduce the immune system response that leads to intestinal damage and villous atrophy in celiac disease. BL-7010 actually binds to the gluten protein, reducing the protein's toxicity.The drug, with the gluten molecule attached, then passes harmlessly through the digestive system to be expelled as stool. BL-7010 has undergone safety testing in humans and was found to be well tolerated. According to BioLineRx, testing will begin in mid-2015 to see if the drug works as expected to diminish gluten's effects on the body. However, BL-7010 is designed to protect only against gluten cross-contamination; it won't allow people with celiac disease to eat large amounts of gluten. CCR9, by Chemocentryx, is a drug called vercirnon, which is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn's disease. CCR9 has completed one Phase 2 trial in 67 patients with celiac disease. However, despite the completion of the trial several years ago, no results relating to celiac disease have been made public or published. Egg Yolk Enzyme. Little is known about efforts to develop a celiac treatment that uses egg yolk to coat gluten and allow it to pass through the body undetected, thus preventing an adverse gluten reaction in sensitive individuals. Like most other drugs being developed, this treatment would work to prevent reactions to small amounts of gluten, rather than as a cure. Larazotide Acetate by Alba Therapeutics. How it works: Larazotide acetate blocks a protein that carries pieces of gluten across the gut, where immune cells can see them. Fasano and his colleagues found that this carrier protein, called zonulin, is overproduced by celiac patients after they eat gluten. Results of the most recent phase 2 trial of larazotide acetate, published in February 2015 in Gastroenterology. The volunteers who took the drug experienced fewer days with disease symptoms during the 12 week-long study. Nexvax2, by ImmusanT, works much like an allergy shot. Nexvax2 exposes the immune system to gluten in a controlled way so that immune cells that are usually activated get turned off or eliminated. So far, Nexvax2 has completed a phase 1 trial showing it to be safe. More research is being done to test whether it is effective. Designed to work as a vaccine, Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Similar to allergy shots, the vaccine is designed to reprogram gluten-specific T cells triggered by the patient's immune response to the protein. ZED1227 by 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. Stay tuned for updates and progress reports as these drugs work their way through their various trial phases. Finally, share your thoughts on all these celiac drugs in the development pipeline. Are you excited, wary, both? Let us know by commenting below. Source: Gastroenterology Report
Celiac.com 07/07/2011 - With diagnosis for celiac disease and gluten intolerance growing by leaps and bounds, it's no wonder that the list of celebrities who eat gluten-free continues to grow as well. Like anyone else with celiac disease and gluten-intolerance, for celebrities and athletes who suffer from either condition, consuming gluten damages the lining of the small intestine and reduces absorption of important nutrients. People with celiac disease are more likely to have autoimmune disorders, Addison’s disease, Down syndrome, intestinal cancer, intestinal lymphoma, lactose intolerance, thyroid disease, and type-1 diabetes. In the United States, approximately 1 out of 133 people are diagnosed with celiac disease. A partial list of some noteworthy celebrities and athletes who reportedly follow a gluten-free diet due to celiac disease, gluten-intolerance, or other reasons include: news host Keith Olbermann, actor Billy Bob Thornton, Elizabeth Hasselback Katherine, Dutchess of Kent, news anchor Heidi Collins, actresses Gwyneth Paltrow, Jennifer Esposito, Goldie Hahn, Rachel Weisz, Zooey Deschanel, Susie Essman, Emmy Rossum, and Heidi Collins. Chelsea Clinton featured a noteworthy gluten-free offering at her wedding reception. Athletes include tennis stars Novic Djokovic, who attributes an unbeaten string of wins in part to a switch to a gluten-free diet. German tennis star Sabine Lisicki looks to bounce back after collapsing on the verge of a major upset at the French Open; a collapse she attributes to an undiagnosed gluten-sensitivity.
Celiac.com 02/05/2010 - Collagenous sprue is classically understood as a disorder of the small intestinal mucosa marked by persistent diarrhea, severe malabsorption with multiple nutrient deficiencies, and progressive weight loss. H. J. Freeman of the Department of Medicine, University of British Columbia Hospital, Vancouver, BC, Canada offers an update on collagenous sprue. Patients with collagenous sprue typically show a severe to variably severe "flattened" mucosal biopsy lesion with distinctive sub-epithelial deposits in the lamina propria region. These deposits contain collagens, as demonstrated by both histochemical stains and ultrastructural studies. Moreover, permanent disappearance of these deposits after resection of a localized colon cancer suggests that this disorder might actually involve a para-neoplastic morphologic marker of an occult malignancy. In collagenous sprue cases, physicians often first consider a diagnosis of simple celiac disease, until the patient fails to respond to a gluten-free diet. Recent studies portray a close association between collagenous sprue and celiac disease, sometimes with concomitant T-cell enteropathy. A number of studies demonstrate gastric and/or colonic associations with the unusual inflammatory mucosal process in collagenous sprue, which suggests that the condition may be more complex and have more varied contributing causes than presently understood. Source: World Journal of Gastroenterology. 2010 Jan 21; 16(3):296-8
Center for Celiac Research Multi-Center Serological Study Update As of September 1, 1998. The University of Marylands Center For Celiac Research has received approximately $190,000 in contributions and pledges. Thanks to those of you who have made pledges and gifts, we have been able to purchase and install a dedicated computer system. The six (6) regional centers have begun minimal screening of study participants. Thanks to a partial grant provided by the University of Trieste, we now have one of the leading international experts in entiendomysium celiac disease assisting us full time in our lab. We have tested 1178 samples as part of the Study for the Prevalence of Celiac Disease in the United States. Our preliminary findings indicate a 6% positive finding of first-degree relatives and 3.4% positive finding of second-degree relatives of Celiacs. These findings are in the same range as were found in most of the European studies done in previous years. As we initially stated in our protocol, we will need to test a total of 45,000 blood samples. All the tools and players are in place - now we need the necessary dollars to put the study into full operation. Blood testing and shipping charges will increase significantly in direct proportion to the samples processed. We thank all of you who have made gifts and pledges. The Celiac community has been very supportive of our grass-roots fund-raising effort. When we began this effort back in May 1997, we suggested that if 1000 Celiacs, relatives or friends would make a commitment to pledge $200 per year for three (3) years we would be on our way to funding this extremely important study. To date we have received ONLY 122 pledges in the amount of $70,335. We have also received a significant number of cash contributions, and as previously announced we were blessed to receive a generous gift of $50,000 from the Oberkotter Foundation. For now, we cannot count on any financial assistance from the NIH. So once again asking YOU to please help us. Remember we are not asking you to make a contribution, but to make an investment in the well being of every Celiac - now and in the future. HOW? If you have not made a pledge or contribution, please consider making one at this time. If possible, increase your current pledge or make an additional gift. Discuss the importance of this study with fellow Celiacs, relatives, friends or whoever might be in a position to help. Ask them to contribute. Organize discussions and/or fund-raising efforts with your local support group. Help us to identify possible organizations, companies, trusts or foundations that might be in a position to help. Contact Pam King, Call (410) 706-8021 for any questions or assistance. All donations and pledges should be made payable to the UM Foundation, Inc. - Center for Celiac Research, Attention: Pamela King, Director of External Affairs, 700 W. Lombard Street, Baltimore, Maryland 21201. These funds are being managed by the UM Foundation, Inc. Thank you again for your commitment to this invaluable research.