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In the first half of 2008, we expect to report data from a proof-of-concept phase 2 hepatitis C virus (HCV) trial to investigate the potential antiviral effects of our proprietary compound SCV-07. This dose-escalating, randomized, placebo-controlled phase 2 trial includes 30 patients. All of the patients in this trial are HCV relapsers infected with the difficult to treat genotype 1 strain of the HCV virus. The primary endpoint of the trial will be a single-log reduction in the hepatitis C viral load though we will also assess many different aspects of the immune response. As HCV does not have an equivalent animal model for preclinical studies, our primary objective is to assess whether SCV-07 could be an effective replacement for interferon alpha in treating HCV patients. About SCV-07 SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects. SCV-07 has shown efficacy in treating various viral and bacterial infections. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections. SCV-07 has shown safety and varied single and multi-dose levels and is orally bioavailable. In addition, SCV-07 has strong intellectual property protection thru “composition of matter” patent claims and is approved already in Russia for tuberculosis. We have exclusive worldwide rights outside of Russia to SCV-07. |
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