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ViroPharma Initiates Phase 2 Study of C1 Esterase Inhibitor [Human] for Treatment of Antibody-Mediated Rejection (AMR)
Date:3/29/2011

EXTON, Pa., March 29, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced initiation of a Phase 2 clinical study to evaluate the safety and efficacy of C1 Esterase Inhibitor [Human] for the treatment of acute antibody-mediated rejection (AMR) in recipients of donor-specific cross-match positive kidney transplants.

This randomized, double blind, placebo-controlled study will evaluate the safety, tolerability and clinical effect of C1 Esterase Inhibitor [Human] for the treatment of acute antibody-mediated rejection in recipients of donor-specific cross-match positive kidney transplants. The study will enroll 20 subjects (10 study drug/10 placebo), and will be conducted at up to four (4) transplant centers in the United States.  Subjects will be assessed after two weeks of treatment for safety, PK/PD, and clinical effect and again at six months post-transplant for graft function and patient survival.  

"Each year, thousands of kidney failure patients fail to receive a potentially life-saving transplant because of pre-existing antibodies to a prospective donor kidney," commented Marc E. Uknis, M.D., ViroPharma's medical director.  "These antibodies initiate complement-mediated inflammation and damage, better known as antibody mediated rejection, or AMR.  These patients, many of whom have a willing but incompatible live donor, are currently added to the deceased donor wait list and many will die waiting for a transplant. Current clinical therapies deal with removing antibodies from the circulation, but do not address the damage to the transplant caused by complement activation.  We have the potential with C1 esterase inhibitor - a complement inhibitor - to add to the treatment paradigms which could then permit broader access to transplantation for patients with such antibodies."

ViroPharma's C1 esterase inhibitor, com
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SOURCE ViroPharma Incorporated
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