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surf1944

11/04/11 8:54 AM

#198 RE: surf1944 #197

2:07AM Santarus and Pharming presents retrospective analyses of data from clinical studies of RHUCIN (SNTS) 2.99 : Co and Pharming Group present data of a retrospective analysis of integrated efficacy data from patients with Hereditary Angioedema undergoing treatment with the investigational drug RHUCIN. A second abstract Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema. Data from 155 patients in the RHUCIN acute treatment studies with 424 administrations of RHUCIN were analyzed. The frequency of anti-C1INH antibodies was low and similar in pre- and post-exposure samples (1.7% and 1.8%, respectively). Occurrence of anti-C1INH antibodies did not correlate with repeated treatment or time since last treatment. No neutralizing antibodies were detected. A total of 5/155 (3%) RHUCIN-treated patients had confirmed anti-host-related impurities (HRI) antibodies, which included one patient with anti-HRI antibodies prior to exposure to RHUCIN. The presence of anti-C1INH and anti-HRI antibodies was not associated with clinical symptoms.