November 4, 2008
Medarex Reports Positive Top-Line Results From Phase II Diarrhea Trial
Medarex, a biopharmaceutical company, and The Massachusetts Biologic Laboratories of the University of Massachusetts Medical School have announced that a Phase II trial of an anti-C difficile antibody combination treatment in patients with C difficile associated diarrhea successfully met its primary objective.
The top-line results from the recently completed multi-center, randomized, double-blind, placebo-controlled Phase II trial indicated a statistically significant reduction in recurrences of C difficile associated diarrhea (CDAD) when compared with placebo.In the study, 200 patients symptomatic with CDAD receiving standard of care antibiotics were randomized to receive either intravenous placebo or intravenous administration of a combination of MDX-066 (CDA-1) and MDX-1388 (CDB-1), two fully human antibodies that neutralize C difficile toxins A and B, respectively.
Consistent with the published literature, the recurrence rate in the placebo-treated group exceeded 20% for patients following successful treatment with standard of care antibiotics. In comparison with placebo, MDX- 066/MDX-1388 treatment reduced recurrence rates by approximately 70% (p=0.0004 on the intent-to-treat population). The antibody combination treatment was generally safe and well-tolerated, the company said.
Howard Pien, president and CEO of Medarex, said: "These results highlight the exquisite specificity of monoclonal antibodies and their important role to save lives. 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."