New Drug Shows Promise in Celiac Disease Clinical Trials
http://www.celiac.com/articles/22753/1/New-Drug-Shows-Promise-in-Celiac-Disease-Clinical-Trials/Page1.html
Tina Turbin
Tina Turbin www.GlutenFreeHelp.info became extremely interested and involved in the subjects of celiac disease, gluten sensitivity and gluten issues a number of years ago, after being diagnosed as celiac after many years of unresolved troubles. Since then, she has engaged in diligent research and writing about these topics, many weekly radio guest spots, developing gluten-free recipes and reviewing companies for celiac consumer safety, and writes monthly for NFCA's Newsletter (www.celiaccentral.org). Tina is an award-winning children's book author and donates her current children's audio book profits to Dr. Peter Green’s Celiac Disease Center at Columbia University Medical Center. To stay updated on her projects and activities and to sign up for her newsletter, visit www.TinaTurbin.com. Tina resides in both her East and West Coast studios and kitchens continuing her writing, promoting and working within the celiac and gluten-free arena, and always writing more children's books to entertain the world.By Tina Turbin
Published on 11/30/2011
A drug to help relieve us from the harmful effects of gluten exposure. Celiac patients are closer than ever to having such a drug on the market.
Celiac.com 11/30/2011 - Researchers have been talking about it for some time, raising the
hopes of the celiac community: a drug to help relieve us from the
harmful effects of gluten exposure. Celiac patients are closer than ever
to having such a drug on the market, as Alvine Pharmaceuticals has
announced that their drug ALV003 has shown promise in a clinical trial
by reducing gluten-triggered harm in people with celiac disease.
Celiac disease is an autoimmune reaction triggered by exposure to gluten, a protein found in wheat, barley, and rye, that causes the immune system to attack the small intestine, interfering with the absorption of nutrients and leading to malnutrition and a variety of other symptoms. The disease currently has only one treatment, which is non-drug: the gluten-free diet. By eliminating gluten completely from the diet, most celiac patients can heal their small intestine. There is currently no other drug on the market that can help relieve the symptoms of celiac disease or the intestinal damage it can cause.
Now
Alvine Pharmaceuticals, which is focused on developing
biopharmaceuticals for autoimmune inflammatory diseases such as celiac
disease, has reported favorable results for a trial with their drug
ALV003, which was developed to lessen mucosal injury in the intestine
caused by gluten exposure in well-controlled celiac patients.
A control group study was conducted that collected data from 34 celiac patients. After both the active drug group and placebo group ingested two grams of gluten on a daily basis for six weeks, "The group with the placebo reported higher incidence of 'non-serious adverse events' (code for GI symptoms)," Triumph Dining reported. "They also had significantly more mucosal injury in their small intestines, as measured by biopsy data."
ALV003 works by breaking down the gluten molecule into nontoxic parts. (Alvine Pharmaceuticals explains more specifically how the drug works on their website, AlvinePharma.com.) The drug is intended to help alleviate the gastrointestinal and other symptoms associated with cross-contamination, incorrect or misleading "gluten-free" labeling, and exposure to gluten caused by carelessness or imprudence. Even when celiac patients take care to maintain a strict gluten-free, it's difficult to stay completely away from gluten. That's why, according to coordinating investigator of the latest ALV003, Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, "New non-dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed."
Currently celiacs have no drug options to help alleviate their symptoms. "These results are groundbreaking," said Professor Maeki, "as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients."
According to Triumph Dining, "After Phase 3 trials, so long as results remain promising, ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval." The release of ALV003, should results remain favorable, will no doubt bring relief to many members of the celiac community.
Celiac disease is an autoimmune reaction triggered by exposure to gluten, a protein found in wheat, barley, and rye, that causes the immune system to attack the small intestine, interfering with the absorption of nutrients and leading to malnutrition and a variety of other symptoms. The disease currently has only one treatment, which is non-drug: the gluten-free diet. By eliminating gluten completely from the diet, most celiac patients can heal their small intestine. There is currently no other drug on the market that can help relieve the symptoms of celiac disease or the intestinal damage it can cause.
Now
Alvine Pharmaceuticals, which is focused on developing
biopharmaceuticals for autoimmune inflammatory diseases such as celiac
disease, has reported favorable results for a trial with their drug
ALV003, which was developed to lessen mucosal injury in the intestine
caused by gluten exposure in well-controlled celiac patients.A control group study was conducted that collected data from 34 celiac patients. After both the active drug group and placebo group ingested two grams of gluten on a daily basis for six weeks, "The group with the placebo reported higher incidence of 'non-serious adverse events' (code for GI symptoms)," Triumph Dining reported. "They also had significantly more mucosal injury in their small intestines, as measured by biopsy data."
ALV003 works by breaking down the gluten molecule into nontoxic parts. (Alvine Pharmaceuticals explains more specifically how the drug works on their website, AlvinePharma.com.) The drug is intended to help alleviate the gastrointestinal and other symptoms associated with cross-contamination, incorrect or misleading "gluten-free" labeling, and exposure to gluten caused by carelessness or imprudence. Even when celiac patients take care to maintain a strict gluten-free, it's difficult to stay completely away from gluten. That's why, according to coordinating investigator of the latest ALV003, Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, "New non-dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed."
Currently celiacs have no drug options to help alleviate their symptoms. "These results are groundbreaking," said Professor Maeki, "as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients."
According to Triumph Dining, "After Phase 3 trials, so long as results remain promising, ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval." The release of ALV003, should results remain favorable, will no doubt bring relief to many members of the celiac community.