Dec. 19, 2012
/PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics (Nasdaq: HALO) announced today that ViroPharma has initiated its Phase 2b double blind, multicenter, dose ranging study to evaluate the safety and efficacy of subcutaneous (SC) administration of Cinryze® (C1 esterase inhibitor [human)] in combination with Halozyme's Enhanze™ technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in adolescents and adults with hereditary angioedema (HAE) for prevention of HAE attacks. Cinryze is currently approved for intravenous (IV) administration.
"Routine prevention of attacks of hereditary angioedema is an important therapeutic option for many patients," commented Prof. Dr. med.
, Department of Dermatology, Venerology and Allergy, Charite – University Medicine
and principal investigator of the study in
. "While the current IV formulation of Cinryze is an important option for patients seeking to prevent their attacks, a subcutaneous formulation could represent a more convenient alternative for many."
This double blind, cross-over, dose ranging study will be conducted in approximately 40 adolescent and adult subjects in the U.S. and
. Qualified subjects will be randomized into one of two 8-week treatment sequences of either 1000 U Cinryze with 24,000 U rHuPH20 or 2000 U Cinryze with 48,000 U rHuPH20 as a twice weekly SC injection. Each subject will participate for approximately 6 months. The primary efficacy endpoint is the normalized number of angioedema attacks recorded during each treatment period. In addition, several secondary endpoints will be assessed, including attack severity, quality of life parameters using a novel angioedema tool, and number of angioedema attacks requiring acute treatment. Additional information about this Phase 2 subcutaneous Cinryze clinical trial can be found at clinicaltrials.gov.
"Our goal is to optimize the delivery and convenience of self administration of Cinryze, and we believe that the combination with rHuPH20 offers us the best opportunity to achieve that goal," commented
, MD, ViroPharma's vice president, clinical research. "The initiation of this important phase 2 study is an essential step toward continually enhancing the Cinryze experience for all patients who seek greater control over their disease through routine prevention."
(C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S. and
, Cinryze is approved for routine prophylaxis (prevention) 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 angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. 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 donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.