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Alvine Pharmaceuticals: ALV003 Shows Promise in Celiac Disease Patients

Celiac.com 11/14/2011 - Alvine Pharmaceuticals claims that Phase 2a clinical trial of ALV003 demonstrates the drug's ability to mitigate gluten-triggered intestinal mucosal damage in serologically negative celiac disease patients who followed a gluten-free diet for one or more years.

Alvine Pharmaceuticals: ALV003 Shows Promise in Celiac Disease PatientsThe company presented findings from the study at the 19th United European Gastroenterology Week (UEGW) in Stockholm. Alvine will present their data in an abstract, titled "ALV003, a Novel Glutenase, Attenuates Gluten-Induced Small Intestinal Mucosal Injury in Celiac Disease Patients: A Randomized Controlled Phase 2A Clinical Trial,"

The results are important because "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal inflammation despite adhering to a strict gluten-free diet," says Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, and coordinating investigator of the ALV003 Phase 2a trial.

Finding a treatment that can help eliminate gut damage in celiacs who are following a gluten-free diet is an important step in improving long-term treatment of celiac disease.

Doctor Peter Green, M.D., agrees. Dr. Green is director of The Celiac Disease Center and professor of clinical medicine at Columbia University College of Physicians and Surgeons. He says that a "gluten-free diet does not completely prevent exposure to gluten and does not affect the underlying cause of disease." This can potentially leave patients "vulnerable to gastrointestinal symptoms and serious long-term medical consequences," he says.

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Simply put, Dr. Green says, "there are currently no approved therapies for celiac disease.

For the trial, 41 adults with clinically proven celiac disease, and who followed on a gluten-free diet for one or more years, received ALV003 or a placebo each day for six weeks. Test subjects also received 2g of gluten in the form of bread crumbs.

Each subject received small bowel biopsy at the start of the trial, and again after six weeks of daily gluten challenge.

Researchers obtained biopsy results from 34 patients. Results showed significantly less small intestinal mucosal injury in patients treated with ALV003 than in placebo-treated patients after six weeks (p=0.013). 

Placebo-treated patients suffered more adverse events, most commonly including abdominal distention, flatulence, eructation, abdominal pain and diarrhea.

"Based on the results of this rigorously conducted trial, we believe that clinical proof-of-principle has been achieved. We are currently preparing for a Phase 2b trial of ALV003 in celiac disease patients targeted to begin in 2012," said Daniel Adelman, chief medical officer at Alvine Pharmaceuticals.

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1 Response:

 
Maudie wood
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
21 Nov 2011 12:40:07 PM PDT
I hope this works!!!




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Wish I could give you a hug. Unfortunately I know how that feels with Neurologists, Internists, Endocrinologists, Rheumatologists, GIs..... I got so tired of crying my drive home after refusing yet another script for Prozac. I do hope your GI can give you some answers even if it is just to rule out other possible issues. Keep on the gluten and we are here for you.

It is too bad that so often a full panel isn't done. Glad your appointment got moved up and hopefully you will get a clearer answer from the GI. Do keep eating gluten until the celiac testing is done. Once the testing is done do give the diet a good strict try. Hang in there.

That makes sense...I cried with relief when I got my diagnosis just because there was finally an answer. Please know that you are not weak or crazy. Keep pushing for testing. It could still be celiac, it could be Crohns. Push your Dr's to figure this out. Best wishes.

Thank you all very much. I actually cried when I got the answer. I wanted an explanation that I could "fix." Now I'm back to thinking I'm just weak and possibly crazy. I know I'm not crazy, but you know.

From what I have read online there is about a 1-3% chance of getting a false positive for celiac disease from a blood test. Was it a blood test that you got done? It may be worth your while to get a biopsy or more testing just to confirm it. I know being gluten free is a pain but it is better than getting cancer or other auto immune disorders.