The poster entitled 'Phase 1 Evaluation of an Oral Suspension of VP 20621, Spores of a Non-Toxigenic C. difficile Strain (NTCD), in Healthy Older Subjects Pretreated With Oral Vancomycin' is being presented today at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in poster session F1-2127b by Stephen Villano, M.D., ViroPharma's vice president of clinical research and development.
The Phase 1 study was designed to determine the safety and tolerability of VP20621 dosed orally as single and repeat escalating doses in healthy young (18 to 45 years of age) and older (60 years of age and older) adults. Because VP20621 was shown to be well tolerated following single and repeat doses in younger and older healthy subjects, the company also performed repeat dosing in older adults following exposure to oral antibiotic. The new data presented today was from healthy subjects above 60 years of age who were pre-dosed with oral vancomycin to disrupt their gastrointestinal flora and render them potentially susceptible to C. difficile colonization. Subjects were subsequently given either placebo or VP20621 doses of 10(4),10(6), or 10(8) spores (once daily for 14 days). Conclusions from the study include:
-- Multiple doses of VP20621 were generally 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. Our goal with VP20621 is to provide a novel, non antibiotic therapy to protect patients from colonization by virulent toxin producing bacteria until their normal, protective GI flora returns, thereby significantly reducing the incidence of recurrent disease for patients with CDI."
About VP20621
Antibiotics including those used to treat acute C. difficile infection (CDI) disrupt the normal gastrointestinal flora which renders individuals susceptible to C. difficile colonization. Orally-dosed liquid VP20621 utilizes non-toxigenic spore-based technology as a potential means of recolonization and protection. The goal of VP20621 dosing following antibiotic exposure is to colonize with this non-toxigenic strain of C. difficile and to prevent colonization by toxigenic strains, thereby preventing disease. VP20621 may have therapeutic utility in the prevention of recurrence following treatment of acute CDI and in the primary prevention of CDI. The most common side effects observed following multiple doses of VP20621 were mild loose or watery stools on a single study day that resolved despite continued dosing, mild burning sensation on the tongue, and mild dyspepsia.
About Vancocin® (vancomycin hydrochloride capsules, USP)
Vancocin® Capsules (vancomycin hydrochloride capsules, USP) is the only antibiotic approved to treat two significant bacterial infections of the lower digestive tract. It may be administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Vancocin Capsules are contraindicated in patients with known hypersensitivity to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin Capsules and other antibacterial drugs, Vancocin Capsules should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Adverse events include nephrotoxicity, ototoxicity, reversible neutropenia and "Red Man's Syndrome." Infrequently, allergic reactions have been reported. Clinically significant serum concentrations have been reported in some patients treated with Vancocin Capsules for pseudomembranous colitis caused by C. difficile. It is noteworthy that total systemic and renal clearance of vancomycin are reduced in the elderly. Monitoring of serum concentrations may be appropriate in patients with renal insufficiency and/or colitis.
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