Halozyme's Enhanze™ technology, a proprietary drug delivery platform using recombinant human hyaluronidase enzyme (rHuPH20) facilitates the absorption and dispersion of drugs or fluids that are injected under the skin. Recombinant HuPH20 transiently generates channels in subcutaneous tissues to increase the absorption and spread of injected drugs.About the StudyThis open-label, multiple-dose Phase 2 study was conducted in 12 subjects with HAE who previously participated in the ViroPharma trial evaluating the pharmacokinetics of subcutaneous injections of Cinryze when given alone relative to intravenous infusion. Qualified subjects participated in a single 18-day study period, followed by a 30-day post-treatment follow-up. A 1000U or 2000U dose of Cinryze in combination with rHuPH20 was administered as a single subcutaneous injection, twice weekly, allowing within-subject comparison across the different methods of administration. Plasma C1 INH functional activity was assessed by chromogenic assay and plasma C1 inhibitor antigenic concentration and C4 complement levels were assessed by ELISA.
ViroPharma And Halozyme Announce Positive Data Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [human]) With Recombinant Human Hyaluronidase (rHuPH20)
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