EXTON, Pa., March 31 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze(TM) (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age 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. Cinryze is not approved in the US for acute treatment of attacks or in pediatric patients below the age of 12 years.
“Hereditary angioedema is an autosomal dominant disease, meaning that each child of a parent with HAE has a 50/50 chance of also being afflicted with the disease; so understanding pediatric dosing requirements is essential for such genetic diseases,” commented Colin Broom, M.D., ViroPharma’s chief scientific officer. “The Cinryze clinical development program includes a pediatric dataset that is among the largest for any HAE therapy. However, we want to further assess various pediatric dosing regimens, particularly for young children. This study will evaluate the efficacy and safety of a range of doses in children and measure plasma concentrations of C1 esterase inhibitor following administration of Cinryze as treatment of acute HAE attacks.”
About Cinryze(TM) (C1 esterase inhibitor [human])
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.
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 on HAE, visit the U.S. HAE Association’s website at: http://www.haea.org/.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company’s web site, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.
CONTACT: Media, Kristina M. Broadbelt, Associate Director, PR & Advocacy,
+1-610-321-2358, or Robert A. Doody Jr., Assistant Director, Investor
Relations, +1-610-321-6290, both of ViroPharma Incorporated
Web site: http://www.viropharma.com/
