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In the fourth quarter of 2009, SciClone announced the enrollment of its first patient in a phase 2 trial of SCV-07 for the treatment of hepatitis C (also known as 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. SciClone Pharmaceuticals is also enrolling patients in its phase 2, multi-center, randomized, double-blind, placebo-controlled study to examine the effect of SCV-07 in the delay to onset of oral mucositis (OM) in patients receiving radio-chemotherapy for the treatment of head and neck cancer. SCV-07 is an investigational drug given subcutaneously.
About SCV-07 SCV-07 is a small molecule which stimulates the immune system through inhibition of STAT3-dependant signaling and the resulting effects on T-helper 1 cells, which are essential for clearance of viral infections. SCV-07 has shown a good safety profile in several early stage clinical trials in healthy volunteers and subjects with HCV at various doses. SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has recently been approved for stimulation of depressed immune systems. |
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