Publications & Reports

The effects of ALV003 pre-digestion of gluten on immune response and symptoms in celiac disease in vivo.

Tye-Din JA, Anderson RP, Ffrench RA, Brown GJ, Hodsman P, Siegel M, Botwick W, Shreeniwas R
The Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia. [email protected]


Effective treatment of celiac disease is an unmet medical need. A glutenase that destroys immunogenic gluten peptides may be clinically valuable. Twenty patients with celiac disease were randomly assigned to ingest a large gluten meal (16 g daily for 3 days) pre-treated with ALV003, a mixture of highly specific glutenases (n=10), or pre-treated with placebo (n=10). Peripheral blood T-cell IFN-gamma ELISpot responses to gliadin and an immunogenic 33mer and symptoms were assessed. While baseline IFN-gamma ELISpot responses to gliadin and the 33mer were negative in all patients, a significant ELISpot response to gliadin or the 33mer was observed in 6 of 10 patients consuming placebo-treated gluten and 0 of 10 consuming ALV003 pre-treated gluten (p=0.011). Symptoms typically associated with gluten ingestion occurred in both groups and were not significantly reduced by ALV003 pre-treatment. ALV003 pre-treatment can abolish immune responses induced by gluten in patients with celiac disease.


  • Journal: Clinical Immunology
  • Published: 01/03/2010
  • Volume: 134
  • Issue: 3
  • Pagination: 289-295