SciClone Pharmaceuticals, Inc. (SCLN) and its partner Sigma-Tau S.p.A., revealed additional topline results in a clinical study evaluating the potential of ZADAXIN to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis (NVS).
According to investigators, ZADAXIN treatment given with the H1N1 vaccine led to a statistically significant increase in the percentage of subjects who seroconverted, also when evaluated 42 days after vaccination, compared to those who received the H1N1 vaccine alone. In addition, the improvement in titers seen in ZADAXIN-treated patients was maintained at this later timepoint.
According to the company, findings showed that, when measured 42 days following vaccination, 93% of patients in the low-dose ZADAXIN arm and 94% of patients in the high-dose ZADAXIN arm achieved seroconversion, compared to only 77% of patients in the vaccine-only arm of the study. This increased seroconversion with ZADAXIN compares favorably with that seen at 21 days following vaccination, which the companies reported in January 2010 as being 89% and 88% in the two ZADAXIN groups, compared to only 56% in patients treated with the vaccine alone, which was a highly statistically significant increase.
The randomized, three-arm open label study is designed to evaluate efficacy based on the proportion of patients achieving seroconversion. The ongoing study, which has a planned duration of six months, is being conducted in patients with end-stage renal disease who are on chronic dialysis.
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