Biolex Therapeutics, a biopharmaceutical company, has started patient dosing in the Select-2 Phase IIb trial of its lead product candidate Locteron for the treatment of chronic hepatitis C.
The Phase IIb trial is being conducted in the US and Europe in 100 treatment-naive, genotype-1, chronic hepatitis C patients. Patients will be randomized into one of four dosing cohorts, the 320, 480 or 640mcg dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron (administered every week), with all patients receiving weight-based ribavirin.
Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response rate. The interim results after 12 weeks of treatment are expected to be used as the basis for the selection of the Locteron dose(s) for Phase III trials.
Locteron, a controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects associated with pegylated interferons, the current standard of care, including flu-like symptoms, said Biolex.
Jan Turek, president and CEO of Biolex, said: The primary objective of the Select-2 Phase IIb trial is to identify one or more doses of Locteron for advancement to Phase III trials based on an evaluation of viral response and safety and tolerability, including reductions in flu-like symptoms.