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.
