Pharming and Swedish Orphan announce publication of randomized clinical trial results with recombinant human C1 inhibitor
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Pharming Group NV and Swedish Orphan Biovitrum announced the publication of the integrated analysis of Pharming's randomized placebo-controlled clinical trials with recombinant human C1 esterase inhibitor (rhC1INH; conestat alfa; Ruconest(TM) in Europe; Rhucin® in other countries) for treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) in the October issue of the peer-reviewed Journal of Allergy and Clinical immunology.
In the publication, Zuraw et al report the results of two similar but independent, randomized, placebo-controlled studies that were conducted in 70 HAE patients in total to evaluate the efficacy and safety of 50 and 100 U/Kg of rhC1INH for the treatment of acute angioedema attacks. In the European study, 32 patients were randomized (16 patients received rhC1INH 100U/kg and 16 patients saline) and 38 patients in the North American study (13 patients received 100 U/kg rhC1INH, 12 patients 50 U/kg and 13 patients saline).
Both doses of rhC1INH (50U/kg and 100U/kg) significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied (abdominal, genitourinary, facial-laryngeal or peripheral) compared to placebo and resulted in high response rate for rhC1INH (>90%). Adverse events occurred less frequently in the rhC1INH arm than in the placebo arm. No antibody responses against rhC1INH or host-related impurities were observed. The authors conclude that rhC1INH constitutes a highly effective alternative to plasma derived C1INH for the treatment of acute angioedema attacks in HAE patients.
Lead author Bruce Zuraw, MD, said: "The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema." Dr. Zuraw is a leading authority on HAE and is Professor of Medicine and Chief, Section of Allergy & Immunology in the Department of Medicine, University of California, San Diego and Research Scientist at the San Diego VA Healthcare, La Jolla, CA.
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