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news.Biolex Therapeutics, a biopharmaceutical company, has reported encouraging results from its US Phase IIa clinical trial of Locteron.
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The Plus Phase IIa clinical trial was conducted in 32 chronic hepatitis C patients in the US 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. The Locteron doses evaluated in the Plus trial include 320mcg, the lowest dose to be evaluated in the Select-2 trial, and 640mcg, 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.
According to Biolex, 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 320mcg cohort of Locteron was 80% lower than the severity score for the PEG-Intron control cohort. The total severity score for patients in the 640mcg cohort of Locteron was 30% lower than the severity score for the PEG-Intron cohort.
Injections site reactions and common hematological parameters among both of the Locteron cohorts and the PEG-Intron cohorts were comparable. Anti-viral effects were comparable among the Locteron and PEG-Intron cohorts, although three of the four patients achieving undetectable virus were in the 640mcg cohort, the company said.
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.
Eric Lawitz, lead author on the trial, said: “The Plus trial clearly met its objectives and sets the stage for extended evaluation of Locteron in larger patient populations. As the treatment for hepatitis C evolves there continues to be a need for a next-generation interferon that can improve patient compliance through a combination of improved tolerability and convenience.”