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Positive results in Phase 2 trial of treatment of C-difficile-associated diarrhea
Date:11/3/2008

owing and serious epidemic, with twenty to fifty percent of hospitalized patients relapsing after receiving antibiotic treatment," said Donna Ambrosino, MD, Executive Director of the MBL and Professor of Pediatrics at UMMS. "The demonstration of significant protection from relapse indicates that treatment with monoclonal antibodies against the toxins could reduce this significant and costly public health problem."

"These results highlight the exquisite specificity of monoclonal antibodies and their important role to save lives," said Howard H. Pien, President and CEO of Medarex. "We believe that the strength of our antibody technology platform for generating potentially important treatment options, such as the C. difficile program antibodies, will continue to shape the future of medicine. Furthermore, Medarex's strategy of proving the utility of potentially promising candidates for development by well-designed and well-executed studies is amply demonstrated."

About Clostridium difficile Acquired Diarrhea (CDAD)

C. difficile is a spore forming bacterium that is common in the environment and can colonize the gastrointestinal (GI) tract. It can be easily spread among hospitalized patients and residents of long term care facilities, but also can be found in otherwise healthy individuals in the community. The origin of disease is believed to develop in the presence of antibiotics administered for other infections, in which the complex microbial make up of the GI tract is altered, and C. difficile spores may germinate, grow, and produce toxins A 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
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Contact: Michael Cohen
michael.cohen@umassmed.edu
508-868-4778
University of Massachusetts Medical School
Source:Eurekalert

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