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ViroPharma Announces Presentation of Data from Non-Toxigenic Clostridium difficile (VP20621) Phase 1 Study
Date:9/15/2010

nerally well tolerated at all dose levels; there were no serious or severe adverse events, and no discontinuations from study drug due to adverse events.
  • All 27 volunteers (100 percent) who were given VP20621 had positive non-toxigenic C. difficile stool cultures by day 6, suggesting that VP20621 rapidly colonizes the susceptible GI tract.
  • No patient dosed with VP20621 tested positive for toxin-producing strains of C. difficile during the 28-day study period.
  • By comparison, 5 of 9 subjects (56 percent) who received placebo (i.e. did not receive VP20621) tested positive for either toxin-negative or toxin-positive C. difficile during the study period.

  • "I am highly encouraged by the data from this Phase 1 study of VP20621, which for the first time support the tolerability and colonization effectiveness of non-toxigenic C. difficile, mimicking what we have inferred from observing colonization of patients with these organisms," commented Dale Gerding, M.D., Associate Chief of Staff for Research at the Hines VA Hospital.  "Colonization protection of VP20621 awaits demonstration in a Phase 2 clinical trial in CDI patients to confirm pre-clinical data and observational studies of natural colonization in humans that have demonstrated high levels of protection against CDI that approach 100%."

    "Previous animal and clinical observational studies have described the prevention of symptomatic CDI by colonization of the large bowel with non-toxin producing strains of C. difficile," commented Dr. Colin Broom, ViroPharma's chief scientific officer.  "We now know that VP20621 appears to behave similarly, rapidly colonizing the large bowel and potentially protecting it from colonization with dangerous toxin-producing strains of C. difficile. We are excited by these positive data and expect to move rapidly into Phase 2 studies with VP20621 in the coming months
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    SOURCE ViroPharma Incorporated
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