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ViroPharma and Halozyme Therapeutics Announce Positive Data From Initial Phase 2 Assessment of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Hyaluronidase (rHuPH20)
Date:12/6/2011

believe that utilization of this cutting edge technology sets the combination apart from subcutaneous delivery of Cinryze without rHuPH20, and increases the likelihood of successful clinical development. It could improve flexibility and convenience, and potentially allow prevention-minded patients living with HAE to self administer every three or four days, just as they do today with the current IV formulation, but with a single subcutaneous injection."  

This open-label multiple-dose study was conducted in 12 subjects with HAE who previously participated in the ViroPharma Phase 2 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 1000 U or 2000 U dose of Cinryze in combination with rHuPH20 was administered as a single subcutaneous injection, two times weekly, allowing within-subject comparison across the different methods of administration.  Additional information about this Phase 2 subcutaneous Cinryze clinical trial can be found at clinicaltrials.gov.

Halozyme's proprietary rHuPH20 enzyme facilitates the absorption and dispersion of drugs or fluids that are injected under the skin. When injected under the skin, rHuPH20 transiently generates channels in tissues underlying the outer layers of the skin to increase the absorption and spread of injected drugs. 

About Cinryze® (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product.  In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.  In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedem
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SOURCE ViroPharma Incorporated
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