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new to the gluten free journey?
Phase 2a Trial Design and Results In the double-blind, placebo-controlled Phase 2a clinical trial, 41 well-controlled, well-characterized adult celiac disease patients were randomized to receive ALV003 or placebo daily for six weeks at the time of ingestion of 2g of gluten (bread crumbs). Study participants underwent small bowel biopsy at the beginning of the trial and after being given the daily gluten challenge for six weeks. The primary endpoint was intestinal villus morphometry (villus height:Crypt depth)(or vh:Cd) measured at baseline and at six weeks. Secondary endpoints included intraepithelial lymphocyte (IEL) density, gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability. Biopsy results from 34 evaluable patients with celiac disease showed that there was significantly less small intestinal mucosal injury in patients treated with ALV003 than in placebo-treated patients at six weeks (p=0.013). In addition, the data showed statistically significant differences in changes in IEL and both alpha/beta and gamma/delta T-lymphocyte subsets. GSRS scores were directionally consistent with the morphologic changes in the intestinal mucosa (i.e., with less intestinal mucosal injury there was a directionally consistent lower GSRS score). No significant changes were observed in the celiac serology tests. Adverse events consistently occurred more frequently in the placebo-treated patients. Adverse events that occurred in 10 percent or more patients included abdominal distension, 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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6 Responses
Yes I and my children would! It would be no different than taking a lactose enzyme. We would still eat gluten free but it would help in those time of cross contamination and when my kids are at school etc. Since they are stunted on growth due to this problem it would help to know there was something else working to make sure she is not effected. As good as the school and teacher do she occasionally gets cross contaminated and has to live with that side effect until it clears her system.
“Can only be used with a strict Gluten Free Diet” OMG how funny is that. We’re already doing that! Sometimes I question the intelligence of the human race.
Oh please. The drug industry is lamely trying to cash in on the fact that many people are gluten intolerant. There are many high quality enzyme supplements already available that are beneficial to the body, and I’m sure much cheaper than any ‘drug’ would be.
If a change in diet resolved the problems of celiac disease, I would have found out about it. I could not have been more committed or more disciplined, yet I still had symptoms. I found that when I take ‘Lectin Lock’ I have fewer symptoms, & the cataract that I developed 4 years ago has disappeared. ‘Lectin Lock’ escorts lectins (kian & gliadin are my particular problem)out of the body. I shall not be taking this drug.
no i would NOT
SEE NO REASON TO TAKE THIS DRUG AS I HAVE BEEN GF FOR 4 MO- FEEL 100% BETTER AND HAVE NOT MADE ONE MISTAKE BY EATING GLUTEN- THE DIET IS EASY TO FOLLOW AS LONG AS YOU DON’T EAT A LOT OF JUNK FOOD/ DESSERTS THAT WOULD CAUSE YOU TO GAIN WEIGHT- EASY FOR ME TO FOLLOW AS I NEVER WAS A FAST FOOD EATER OR EATER OF SNACK FOODS/SWEETS- i ATE EVERYTHING WHEAT AS WE WERE LED TO BELIEVE IT WAS GOOD FOR US- GUESS THEY ARE WRONG-