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Medarex and Massachusetts Biologic Laboratories Announce Primary Objective Achieved in Phase 2 Trial of Monoclonal Antibody Combination for the Treatment of Clostridium difficile Associated Diarrhea (CDAD)
Date:11/3/2008

and B. The toxins cause damage to the GI tract lining in the colon, resulting in severe diarrhea, and may lead to perforations of the colon and/or death. Treatment of severe disease requires administration of additional antibiotics to kill the C. difficile bacteria, but because of the persistence of spores, as well as the difficulty for the intestinal flora to re-normalize in the setting of antibiotics, relapse/recurrence of CDAD is common, and is estimated to occur in 20 percent of cases, with post-therapy recurrence rates as high as 60 percent.(4) Recurrence can be difficult to manage and is a challenging complication of CDAD; however, the use of non- antibiotic based approaches to neutralization of C. difficile toxins may be important options needed to facilitate recovery of the GI flora.(5)

More information on CDAD can be accessed through the following websites:

Centers for Disease Control and Prevention website at http://www.cdc.gov/ncidod/dhqp/id_Cdiff.html

ICAAC/IDSA 2008 website for abstracts at http://www.icaacidsa2008.org/

About MDX-066 (CDA-1) and MDX-1388 (CDB-1)

MDX-066 (CDA-1) and MDX-1388 (CDB-1) are novel, fully human antibodies that were developed by MBL and Medarex to target and neutralize the effects of toxin A and toxin B, respectively, the toxins produced by the bacterium C. difficile and which are associated with a serious and sometimes deadly form of diarrhea called C. difficile associated diarrhea. Published epidemiologic studies of hospitalized patients at risk for CDAD have shown a positive correlation between detectable levels of antibody in the blood to both toxins A and B and protection from disease or relapse.

In a presentation at the recent joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Socie
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SOURCE Medarex, Inc.
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