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news.Medarex and The Massachusetts Biologic Laboratories of the University of Massachusetts Medical School have initiated a phase II clinical trial of CDA-1, a novel fully human monoclonal antibody developed for the treatment of hospitalized patients diagnosed with C difficile associated diarrhea.
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The single-dose phase II clinical trial will be conducted at hospitals in Massachusetts and California and is expected to enroll up to 150 patients with C difficile associated diarrhea.
The study is designed to assess the safety and tolerability of CDA-1 when added to standard of care and to measure and compare the duration of C difficile associated diarrhea after treatment, the length of hospital stay and recurrence of the disease after treatment between the placebo and treatment arms.
“The number of people getting sick, and in some cases dying of this condition has increased dramatically. So we remain committed to this new approach and hope it will continue to show promise,” said Dr Donna Ambrosino, director of the MBL and a professor of pediatrics at the medical school.