SciClone Pharmaceuticals, Inc. (SCLN) said that Rome-based development partner Sigma-Tau, S.p.A. has initiated a pilot study in Italy to evaluate ZADAXIN's ability to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine Focetria from Novartis.
The study, being conducted in hemodialysis patients, is now completely enrolled, having reached full enrollment after two days. Top-line clinical results are expected by late 2009 or early 2010.
SciClone and Sigma-Tau conducted preclinical studies earlier this year to demonstrate the potential of ZADAXIN to enhance the immune response to H1N1 pandemic flu vaccines. Preclinical studies including one with ferrets demonstrated the feasibility of ZADAXIN to fit into the one or two dosing regimens of such vaccines.
The randomized, three-arm open study is being conducted in about 120 patients with end-stage renal disease who are on chronic dialysis.
The primary efficacy endpoint is the proportion of patients who achieve seroconversion. Additionally, patients will be followed for six months to assess the durability of the protective titers.
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