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Showing results for tags 'protects'.
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Celiac.com 06/02/2014 - Despite following a gluten-free diet, many people with celiac disease continue to have symptoms, and to suffer from ongoing small intestinal inflammation. Can a drug be created to alleviate such symptoms and inflammation, and protect celiacs on a gluten-free diet against small amounts of gluten contamination? San Carlos California-based Alvine Pharmaceuticals is conducting a phase 2 trial to determine whether their drug, ALV003, an orally administered mixture of 2 recombinant gluten-specific proteases can protect celiac disease patients from gluten-induced mucosal damage. For this trial, Alvine is working with researchers Marja-Leena Lähdeaho, Katri Kaukinen, Kaija Laurila, Pekka Vuotikka, Olli-Pekka Koivurova, Tiina Kärjä-Lahdensuu, Annette Marcantonio, Daniel C. Adelman, and Markku Mäki. They are affiliated with the School of Medicine and Tampere University Hospital at the University of Tampere; the Department of Gastroenterology and Alimentary Tract Surgery at Tampere University Hospital and School of Medicine at the University of Tampere, and FinnMedi Oy in Tampere, Finland; the Department of Medicine at Seinäjoki Central Hospital in Seinäjoki, Finland; Liikuntaklinikka, Oulu Diakonissalaitos; and Terveys, Oulu Diakonissalaitos, Oulu, Finland. For their Phase 2 trial, the research team first established two grams of gluten per day as the optimal challenge dose for their 6-week gluten study. They then randomly assigned 20 adults with biopsy-proven celiac disease to receive ALV003, and twenty-one to receive a placebo. Both groups also received 2 grams of gluten each day. The team conducted duodenal biopsies at baseline, and after gluten challenge, focusing on the ratio of villus height to crypt depth and densities of intraepithelial lymphocytes. A total of seven patients dropped out due to adverse reactions. Four were receiving ALV003, and three were receiving the placebo. Sixteen patients given ALV003 and 18 given placebo were eligible for efficacy evaluation. Biopsies from subjects in the placebo group showed evidence of mucosal injury after gluten challenge, with average villus height to crypt depth ratio changed from 2.8 before challenge to 2.0 afterward. (P = .0007; density of CD3þ intraepithelial lymphocytes changed from 61 to 91 cells/mm after challenge; P = .0003). However, the team saw no significant mucosal deterioration in biopsies from the ALV003 group. The two groups showed no significant differences in symptoms, though they did show substantial differences in morphologic changes, and CD3þ intraepithelial lymphocyte counts differed significantly from baseline to week 6 (P = .0133 and P = .0123, respectively). This small, but important, step means that ALV003 did provide significant protection against gluten-induced gut damage for people with celiac disease on an otherwise gluten-free diet, which means that Alvine can continue to the next phases in the development process. If successful, glutenase ALV003 will be the first drug to protect people with celiac disease against gut damage from small amounts of gluten. Source: Clinicaltrial.gov, Numbers: NCT00959114 and NCT0125569
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Celiac.com 03/11/2013 - People with celiac disease must follow a gluten-free diet if they want to remain healthy, but a 200-patient study conducted by Alvine Pharmaceuticals show that 90 percent of celiac patients who followed a gluten-free diet still reported symptoms of the disease. That reality is helping to drive an effort by Alvine to develop a drug that would help those people to avoid symptoms and damage that come with accidental exposure to gluten. According to a recent press release, Alvine had already raised at least $42 million for its celiac disease drug, and now has $6 million more as it works through a second phase 2 trial. The company's top drug prospect is ALV003, a mix of two recombinant gluten-specific proteases that’s designed to be used along with a gluten-free diet to prevent immune reactions associated with celiac disease. As disclosed in a recently filed U.S. Securities and Exchange Commission document, the company has raised at least $6 million in debt and other non-equity securities, and could raise up to $500K more. ALV003 is designed to be taken orally by people with celiac disease at the time of a meal. It mixes with and breaks down the gluten in food before it can reach the small intestine, where it would cause inflammatory responses. The drug is designed to prevent accidental gluten contamination, not to allow celiac sufferers to freely and safely consume large amounts of gluten. In a phase 2a study, ALV003 met its goals and reduced gluten-induced intestinal injury in celiac patients who were already following a gluten-free diet. According to clinicaltrial.gov, ALV003 is presently in a study phase with a March 2013 completion date. In the fall of 2012, Alvine received permission from the U.S. Food and Drug Administration to fast-track ALV003, which means the company can work more closely with the FDA during clinical trials, and may get a faster review if they file a New Drug Application. Alvine is a San Carlos, California-based biopharmaceutical company founded in 2006 on technology from Stanford University. Its investors include Abbott Biotech Ventures, Panorama Capital, InterWest Partners, Prospect Venture Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures. Read more here.
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Celiac.com 10/26/2011 - In vitro and in clinical studies have shown that oxidative stress plays a role in gluten-induced toxicity, but no studies have observed this activity in living tissue. A research team set out to examine the role of nuclear factor erythroid 2-related factor2 in gliadin-mediated toxicity in human Caco-2 intestinal cells and in gliadin-sensitive human leukocyte antigen-DQ8 transgenic mice (DQ8), along with assessing the protective activity of CLA. The research team included Paolo Bergamo, Marta Gogliettino, Gianna Palmieri, Ennio Cocca, Francesco Maurano, Rosita Stefanile, Marco Balestrieri, Giuseppe Mazzarella, Chella David, and Mauro Rossi. The team had previously observed the protective role played by conjugated linoleic acid (CLA), which works by the activation of nuclear factor erythroid 2-related factor2 (Nrf2), which serves as a crucial transcription factor for the synthesis of antioxidant and detoxifying enzymes (phase 2). To assess gliadin effects in differentiated Caco-2 cells and in DQ8 mice, they fed the mice a gliadin-containing diet with or without CLA supplementation, and then combined enzymatic, immunochemical, immunohistochemical, and quantitative real-time PCR (qRT-PCR) data. In both laboratory tests, and in living tissue tests, they found gliadin toxicity accompanied by downregulation of phase 2 and elevated proteasome-acylpeptide hydrolase activity. Interestingly, in DQ8 mice intestine, gliadin did not generate severe oxidative stress extent or pathological reactions like those found in celiac patients. Moreover, the reactions that did result were mitigated by CLA. From these results, the researchers conclude that CLA offers beneficial effects against the reduction of key intestinal cytoprotective defenses. This indicates a new nutritional approach for the treatment of intestinal disease associated with altered redox homeostasis. Source: Molecular Nutrition and Food Research; Vol 55 Issue S2. DOI: 10.1002/mnfr.201100295
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Cigarette Exposure Protects Against Adult Celiac Disease
Scott Adams posted an article in Latest Research
Eur J Gastroenterol Hepatol. 2003 Sep;15(9):995-1000. Celiac.com 08/27/2004 - Past studies have demonstrated an association, but not a causal connection, between cigarette smoking and celiac disease. Using the Bradford Hill criteria British researchers have now established a causal connection. In a matched case-control study, the researchers utilized a questionnaire to obtain the smoking histories of 138 celiacs and 276 age-matched and sex-matched controls. The subjects were then categorized according to their pre-diagnosis cigarette exposure, and it was found that 10% of celiacs, and 30% of the controls were smokers during this time. A biological gradient was demonstrated for total, recent and current cigarette exposure, and the greatest risk reduction related to current exposure. The researchers conclude: "This study strengthens the case for a causal relationship between smoking and coeliac disease by demonstrating a strong, temporally appropriate and dose-dependent effect, thus meeting the Bradford Hill criteria. This suggests that cigarette smoking truly protects against the development of adult coeliac disease."
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