The trial is designed to evaluate the therapeutic effect of its SCV-07 compound on patients with HCV.
The objective of the trial is to demonstrate SCV-07’s effect on hepatitis C viral load as well as on other measures of immune response. The company expects to report data in the first quarter of 2008.
“If we are able to determine that SCV-07 stimulates the immune system in a method similar to that of interferon alpha, but without side effects, this could be a significant treatment advance for patients suffering from HCV,” said Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals.
The randomized, placebo-controlled trial plans to enroll 30 patients infected with the genotype 1 strain of the HCV virus who previously responded to treatment with interferon alpha and ribavirin, but subsequently relapsed. Patients will be randomized into three cohorts of escalating doses, and will receive daily subcutaneous injections of SCV-07 or placebo.
After completing seven days of therapy, all patients will be monitored for 14 days. The primary endpoint of the trial will be a single-log reduction in the hepatitis C viral load.