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Flamel hepatitis C drug performs well in trial

A phase I/II study into Flamel Technologies' drug candidate IFN-alpha-XL, for the treatment of hepatitis C, suggests the drug possesses long-acting activity as well as a high degree of tolerability.

IFN-alpha-XL utilizes 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.

“Interferon therapy is a cornerstone in the treatment of chronic hepatitis C infection, but today its use is limited by the significant side effects associated with approved formulations of Interferon-alpha,” said lead investigator of the study, possesses, Hotel Dieu Hospital-Lyon.

“The results of this first study of IFN-alpha-XL are very promising, and suggest that this novel formulation of interferon alpha may provide equivalent and possibly better therapeutic benefit with fewer side effects in comparison to existing interferon-alpha therapies.”

The dose-escalating study was conducted in 53 patients 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 (12 – 14 patients per dose). 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.