Oct 22, 2009 (Datamonitor via COMTEX) -- SciClone Pharmaceuticals, a biopharmaceutical company, has initiated enrollment in a Phase II trial of SCV-07 for the treatment of hepatitis C virus or HCV.

This multicenter, multidose, open-label study is designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy or in combination with ribavirin in non-cirrhotic patients with genotype 1 chronic HCV who have relapsed after at least 44 weeks of treatment with pegylated interferon and ribavirin.

The study, which will monitor biomarkers of immune activation and HCV viral load dynamics, will include two treatment cohorts of 20 patients each, who will receive SCV-07 at a dose of either 0.1mg/kg or 1mg/kg.

The treatment period will be approximately eight weeks long, including four weeks of SCV-07 monotherapy followed by four weeks of SCV-07 in combination with ribavirin. In addition, there will be three follow-up visits within seven weeks after the completion of treatment.

Friedhelm Blobel, president and CEO of SciClone, said: "During our previous Phase IIa clinical trial of SCV-07 as a monotherapy to treat patients with chronic hepatitis C infections, we were pleased by the safety data and were very encouraged by the efficacy signal, namely, a reduction of viral loads and a corresponding increase in neopterin concentration in some patients after only seven days of SCV-07 administration.

"SciClone is eager to investigate further SCV-07's potential to enhance the immune response against hepatitis C and to determine whether the compound is capable of improving the current standard of care treatment."

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