SciClone Pharmaceuticals Inc. (SCLN) said the company and its partner Sigma-Tau S.p.A. received initial topline results in a clinical study evaluating the potential of ZADAXIN to improve immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis.
ZADAXIN is SciClone's synthetic preparation of thymalfasin, a peptide produced by the thymus gland that circulates in the blood naturally and is instrumental in immune responses.
The randomized, 3-arm open label study has a planned duration of 6 months and hence is still ongoing and is being conducted in patients with end-stage renal disease who are on chronic dialysis. SciClone Pharma stated that this ongoing study is designed to evaluate efficacy based on the proportion of patients achieving seroconversion, a significant rise in specific antibody titers against H1N1 influenza.
According to investigators, at 21 days following vaccination, 89% of patients in the low-dose ZADAXIN arm achieved seroconversion as did 88% of patients in the high-dose ZADAXIN arm, compared to only 56% of patients in the vaccine-only arm of the study, the company noted.
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