SAN DIEGO, Aug. 1, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that following discussions with the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration, ViroPharma will be discontinuing their Phase 2 study of subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) with recombinant human hyaluronidase (rHuPH20). The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. These antibodies have not been associated with any adverse clinical effects.
"Given the profile of this clinical formulation and the time required to enable ViroPharma to move forward with this formulation, we support ViroPharma's business decision," said
Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "We have accumulated a robust data set regarding the clinical use of rHuPH20 across many different programs and indications, and feel confident about the safety profile of the rHuPH20 platform that has emerged from this clinical use and its continued application in our other products and programs around the world."
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