ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

Apr 27 2010

ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze™ (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema (HAE).  Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.

"The experience with intravenous delivery of Cinryze has been exceptional, with many patients taking advantage of our unique labeling option of self-administration and dosing themselves in their homes or wherever their schedule takes them," commented Judy Johnson, ViroPharma's vice president of clinical pharmacology and non-clinical development. "Based on encouraging data from a previous single-dose Phase 1 study in healthy subjects, we believe that subcutaneous administration of Cinryze may become a viable alternative mode of administration for routine prophylaxis of HAE attacks."

Clinical Study Design

This multi-center, open-label multiple dose study will be conducted in 24 adolescent and adult HAE patients in the US and Europe. All eligible subjects will be randomized into one of two treatment groups:  Patients will receive Cinryze via IV infusion two times per week for two weeks.  Then, following a 14-day washout period, patients will receive Cinryze via subcutaneous administration at one of two dose levels (either 1000U or 2000U) two times per week for two weeks.  Safety and PK/PD assessments will be evaluated throughout each treatment period.