Novel Fully Human Antibody


The Massachusetts Biologic Laboratory (MBL) of the University of Massachusetts Medical School (UMMS) and Medarex, Inc announced the allowance of an Investigational New Drug (IND) application filed with the US Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of CDA - 1 (also referred to as MSX-066), a novel fully human monoclonal antibody designed to treat a serious and sometimes deadly form of diarrhea called Clostridium difficile associated diarrhea (CDAD), which can complicate the stays of hospitalized patients and residents of long-term care facilities. The dose-escalation Phase 1 trial of CDA - 1 is expected to enroll up to 30 healthy volunteers. The participants will be monitored for any adverse side effects, and their blood will be tested to measure the concentration of the antibody in their systems.

CDAD is typically treated with antibiotics alone. However, approximately 20% of those affected by CDAD suffer a relapse of the disease after treatment, and approximately two percent of those afflicted with CDAD die of the disease. CDA - 1, which would be used in conjunction with antibiotic treatment, is believed to work by binding to a toxin released by C difficile, thereby forestalling the disease state that arises from the toxin's effect on the intestinal tract.

It is a expected that this antibody will help shorten the duration of disease in people, reduce their length of stay in hospital and/or prevent recurrence.


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