SciClone Pharmaceuticals, Inc. (SCLN) Tuesday said the company along with its partner Sigma-Tau S.p.A. achieved topline results in a clinical study to evaluate the potential of Zadaxin to increase immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis.
The company said Zadaxin treatment given with the H1N1 vaccine led to a highly statistically significant increase in the percentage of subjects who seroconverted at 21 days after vaccination, compared to those who received the H1N1 vaccine alone. Seroconversion is defined as a four fold or greater change in titers from baseline.
The study has a planned duration of 6 months and is still ongoing. It is being conducted in patients with end-stage renal disease who are on chronic dialysis in two different group of patients selected for two different dosage. Dosing regimens were based on preclinical results obtained in ferret and mouse models conducted in Europe and the U.S. earlier this year.
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. 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.
Zadaxin is currently approved in more than 30 countries worldwide to treat a variety of indications. In clinical studies, more than 4,000 patients being treated with vaccines or infected with viral hepatitis B or hepatitis C, primary immunodeficiency diseases, or various cancers have been treated with Zadaxin with virtually no drug-related side effects. About 100,000 patients worldwide have used Zadaxin in both clinical and commercial settings, alone and in combination with various antiviral and anticancer drugs.
Friedhelm Blobel, SciClone's President and Chief Executive Officer said, "We hope that this pilot study will be completed successfully and that we can proceed thereafter with applications for regulatory approval regarding the use of Zadaxin as an enhancer for vaccinations for H1N1 influenza using a one or two shot dosing regime. We have obtained regulatory approval for Zadaxin for use as an adjuvant for regular influenza in more than 10 countries using multiple injections."
SCLN is currently traded at $2.99 up $0.22 or 7.94% on the Nasdaq.
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