Biolex Therapeutics, Inc. announced that the results from its United States Phase 2a clinical trial (the "PLUS" trial) of Locteron will be presented today at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. Locteron, 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, including flu-like symptoms, associated with pegylated interferons, the current standard of care. Biolex announced earlier this week the commencement of patient dosing in the SELECT-2, a Phase 2b trial of Locteron in the United States and Europe.
The PLUS Phase 2a clinical trial was conducted in 32 chronic hepatitis C patients in the United States who had failed prior treatment. The PLUS trial was designed to evaluate the safety and tolerability of Locteron, and to directly compare Locteron with pegylated interferon. Patients were randomized to receive either Locteron (administered once every two weeks) or PEG-Intron (administered once per week). The Locteron doses evaluated in the PLUS trial include 320 μg, the lowest dose to be evaluated in the SELECT-2 trial, and 640 μg, the highest dose of Locteron evaluated to date. All patients also received oral, weight-based ribavirin. Patients were treated for four weeks with an additional two weeks of follow up evaluation.
Flu-like symptoms were reported to be less frequent and milder in both of the Locteron cohorts of the PLUS trial. The total severity score for flu-like symptoms for patients in the 320 g cohort of Locteron was 80 percent lower than the severity score for the PEG-Intron control cohort (severity score was based on number of occurrences adjusted for severity rating of adverse event). The total severity score for patients in the 640 g cohort of Locteron was 30 percent lower than the severity score for the PEG-Intron cohort.
|Contact: Michelle Linn|