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Alexion Pharmaceuticals, Inc.
today announced that researchers
have presented preliminary data from a single-arm Phase 2 study of eculizumab
(Soliris^®) as an investigational therapy to prevent acute antibody-mediated
rejection (AMR) in sensitized deceased-donor kidney transplant recipients. The
composite primary endpoint was the nine-week occurrence of
post-transplantation treatment failure, which occurred in 10.6% of the 47
patients reported today, including a 6.4% rate of AMR^1 compared to an
expected 30% rate of AMR^2 in this highly sensitized population of kidney
transplant recipients. The data were presented today in an oral presentation
at the 2013 annual congress of the European Society for Organ Transplantation
(ESOT) in Vienna, Austria.
Acute AMR can lead to severe kidney allograft damage resulting in rapid loss
of function and possible loss of the transplanted kidney, which makes AMR a
significant clinical barrier to transplantation in sensitized patients.^3
Research suggests that uncontrolled activation of complement, triggered by the
binding of donor-specific antibodies (DSAs) to their target proteins
(antigens) of the donor kidney, may be the primary reason for acute AMR in
kidney transplant recipients who are sensitized, or have DSAs, to their
donors.^3,4 Prophylaxis with a terminal complement inhibitor, such as
eculizumab, is thus considered a potential strategy to prevent acute AMR.
There are no approved treatments for the prevention of acute AMR.
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