MEDAREX INITIATES TRIAL OF C. DIFFICILE ANTIBODIES
Medarex and the University of Massachusetts Medical School have begun a randomized, double-blind, placebo-controlled Phase II trial of CDA-1 and MDX-1388, two fully human monoclonal antibodies developed to Clostridium difficile (C. difficile) toxin A and toxin B, respectively, for the treatment of C. difficile associated diarrhea (CDAD).
The single-dose trial is expected to enroll up to 200 patients with CDAD and is designed to assess the efficacy of the combination of CDA-1 and MDX-1388 versus placebo as an addition to standard antibiotics to resolve CDAD more quickly and to prevent subsequent disease relapse.
A newly identified epidemic strain of C. difficile has been implicated in severe outbreaks of CDAD in the U.S., Canada and the UK, and has affected otherwise healthy individuals. The virulence of the new strain has been attributed, at least in part, to a markedly increased efficiency of production of toxins A and B. The epidemic strain appears to cause more severe illness initially and to result in a higher rate of relapse.
Previously released data showed that the CDA-1 and MDX- 1388 antibodies effectively neutralized the toxins from the epidemic strain of C. difficile in a preclinical study. In addition, published epidemiologic studies of hospitalized patients at risk for CDAD have shown a positive correlation between detectable levels of antibody in the blood to toxin A and protection from disease or relapse.
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