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ViroPharma Announces Publication of Cinryze™ (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
Date:8/5/2010

ns.  With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent.  With Cinryze, the risk of transmission of infectious material has been reduced by screening patients for prior exposure to certain virus infections and by manufacturing steps designed to reduce the risk of viral transmission including pasteurization and nanofiltration.

"Due to the lack of awareness about HAE, which is a rare, debilitating and potentially-life threatening disease, patients are often misdiagnosed and undergo unnecessary exploratory surgeries before receiving an accurate diagnosis," said Zuraw, professor of medicine and program director of the Allergy and Immunology Fellowship Program at the University of California at San Diego, and lead author and principal investigator of the study.  "It is vital for healthcare providers to understand the disease and available prophylactic options so HAE patients can be effectively diagnosed and managed.  Our hope is that published data like these, showing the safety and efficacy of an FDA-approved therapy such as Cinryze, will educate physicians and patients about the options now available to help prevent HAE attacks."

Cinryze Prophylaxis Study

According to the authors, the prophylaxis study employed a cross-over design to compare Cinryze with placebo in preventing attacks of angioedema during a 24-week period.  The study consisted of two consecutive 12-week treatment periods during which subjects received prophylactic injections every 3 to 4 days.  Subjects were randomized to receive either Cinryze (1000 U) or placebo during the first period.  During the second period, each subject crossed over to receive whichever study medication he or she had not received during the firs
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SOURCE ViroPharma Incorporated
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