ViroPharma Incorporated 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(TM) (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."

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.

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency. Cinryze is not currently approved in the European Union or any of its member states.

The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. 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. The risk has been reduced by screening plasma donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.

Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.

For more information visit: http://www.viropharma.com/.

 

Source: web of pharmoutsourcing