BioCentury
ARTICLE | Clinical News

MDX-066: Final Phase II data

February 1, 2010 8:00 AM UTC

Final data from the double-blind, U.S. and Canadian Phase II CA-GCDX-06-02 trial in 200 patients receiving standard of care antibiotics metronidazole or vancomycin showed that a single IV infusion of 10 mg/kg MDX-066 plus 10 mg/kg of Medarex's MDX-1388, a mAb against C. difficile toxin B, met the primary endpoint of a significantly lower rate of recurrence of C. difficile infection vs. placebo (7% vs. 25%, p<0.001). The antibody combination missed the secondary endpoints of significantly reducing the severity of diarrhea during the initial episode, reducing the median or mean time to resolution of the initial episode and reducing the proportion of patients who experienced treatment failure vs. placebo. The rate of recurrence in patients with the epidemic BI/NAP1/027 strain of C. difficile was 8% for the antibody combination vs. 32% for placebo (p=0.06). Data were published in the New England Journal of Medicine. Medarex, a subsidiary of Bristol-Myers, reported top-line data from the trial in 2008 (see BioCentury, Nov. 10, 2008). ...