Passive Immune Therapy for Helicobacter Pylori Incection

Helicobacter pylori is a gastrointestinal pathogen that causes, or is a major risk factor for thedevelopment of a spectrum of diseases including chronic gastritis, peptic ulcer, and cancer of thestomach. Current therapies for these diseases are inadequate as they are plagued with high recurrencerates or adverse side effects. Orally administered passive antibodies targeting H. pylori virulence factorsare an attractive alternative to current treatments because they are inherently safe, pathogen-specificand should eradicate the organism from the host. Herein, Ophidian proposes to purify H. pylori virulencefactors (urease and bacterial cell-surface structures) and raise corresponding high-titer polyclonalantibodies in laying hens. Hen egg antibody has been shown to retain function during passage throughthe gastrointestinal tract and can be readily produce in large quantity. Antibodies will be isolated fromegg yolks, and assessed for urease neutralization activity and ability to prevent H. pylori adher-ence/colonization of CHO cells. A gerbil model will be used to show the effectiveness of theseantibodies in preventing H. pylori infection when orally delivered. The results of this Phase I study showthe feasibility of passive immune therapy to treat H. pylori infections and will provide a betterunderstanding of specific factors related to H. pylori virulence.