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OctoPlus presents positive Locteron Phase IIa study results at EASL conference

25 Apr 2008 - OctoPlus N.V. presented extended results from its successful SELECT-1 Phase IIa clinical trial of Locteron® for the treatment of chronic hepatitis C (HCV) at the 43rd Annual Meeting of the European Association for the Study of Liver Diseases (EASL).
 
The study results presented at EASL show a strong and statistically significant effect of Locteron on the amount of HCV virus particles, and this effect increased with higher doses. Patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for other interferons. Biomarker results demonstrate Locteron's biological activity with sustained presence of interferon alfa in the body, and showed improvement of liver function in terms of liver enzyme test results. SELECT-1 was a twelve-week trial in 32 treatment-naïve patients with the genotype 1 variant of the hepatitis C virus. The Phase IIa trial was designed to evaluate four doses of Locteron administered once-every-two-weeks in combination with the antiviral drug ribavirin. The SELECT-1 study was completed in October 2007. Viral kinetic modeling of the SELECT-1 results by Eva Herrmann, Ph.D. of Saarland University, Homburg/Saar, Germany and Stefan Zeuzem, M.D. of J.W. Goethe-University Hospital, Frankfurt/Main, Germany, demonstrated a statistically significant dose response to Locteron. Extended results presented at the EASL meeting also included the effect of Locteron on the improvement of liver function in terms of ALT liver enzyme profiles, and on the biomarkers OAS and neopterin, each of which showed a dose-dependent response to Locteron.