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Replidyne's Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
Date:9/19/2007

1 ug/mL) for all C. difficile strains tested. In contrast, widely used agents such as vancomycin and metronidazole did not reduce toxin production in these high density cultures even at drug concentrations well above those required to inhibit growth of the bacteria. The levels of toxins were monitored by immunoassays using antibodies that specifically recognize two disease-causing factors, toxin A and toxin B. The dramatic reduction in the deleterious effects of the toxins was directly demonstrated by the gold standard cytotoxicity assay, which uses human fibroblasts to confirm the ability of REP3123 to block toxin production. The FDA has not approved REP3123 for marketing in this or any other indication.

"CDAD is a challenging disease because of the difficulty in managing patients with severe manifestations as well as the problem of recurrence in those patients who recover from the initial episode. As the disease is primarily toxin-mediated, new therapies that act by means other than simply eradicating the bacteria may be very helpful and should be studied," stated Stuart Johnson, M.D., Associate Professor of Medicine, Stritch School of Medicine, Loyola University and the Hines VA Medical Center in Chicago. "The finding that REP3123 has a direct impact on inhibiting toxin production of C. difficile bacteria is very important and equally as exciting."

"C. difficile-associated diseases have become a serious health matter in both the hospital and community settings," stated Kenneth J. Collins, Replidyne President & CEO. "These results, along with the sporulation-inhibition findings also reported today, are very encouraging and we look forward to the further development of REP3123."

About Clostridium difficile

C. difficile is a Gram-positive anaerobic bacterium that causes C. difficile-associated disease (CDAD). CDAD is on the rise worldwide, both in terms of number of cases and severity of the disease. Most cases of CDAD occur in a hospital se
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SOURCE Replidyne, Inc.
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