Halozyme Therapeutics, Inc. 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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