FLAMEL TECHNOLOGIES ANNOUNCES RESULTS OF HEPATITIS C STUDY

Flamel Technologies has announced preliminary Phase I/II data from a trial demonstrating the safety, tolerability, and long-acting activity of IFN-alpha-XL in patients with chronic hepatitis C virus (HCV) infection. Data also show that IFN-alpha-XL had positive effects on viral load and interferon activity biomarkers. IFN-alpha-XL utilizes Flamel's proprietary Medusa nanoparticle technology to provide a long-acting formulation of interferon alpha that may have enhanced efficacy and reduced toxicity compared with unmodified or PEG-modified interferon formulations.

The dose-escalating study was conducted in 53 subjects with chronic hepatitis C. Thirty-nine participants were assigned to receive a single subcutaneous injection of one of three escalating doses of IFN-alpha-XL. The three IFN-alpha-XL groups received an injection of 9 million international units (MIU), 18 MIU, and 27 MIU, respectively. A cohort of 14 patients received three subcutaneous injections of a standard dose of Viraferon over one week as a comparator. All patients completed the study, and no serious adverse events were reported.