OctoPlus Announces Results for Locteron Phase IIa Trial
OctoPlus and Biolex Therapeutics announced positive initial results of the ongoing Safety and Efficacy of Locteron: European Clinical Trial 1 (SELECT-1) Phase IIa study with Locteron, a controlled release interferon alfa for the treatment of chronic hepatitis C (HCV).
According to OctoPlus and Biolex, the 12-week, multicenter, randomized, open-label Phase IIa study was designed to evaluate Locteron in combination with the antiviral drug ribavirin in previously untreated HCV patients.
Locteron was administered once every two weeks in subcutaneous doses of 160, 320, 480 or 640 micrograms in combination with ribavirin, the companies said.
Dosing of the first three eight-patient groups commenced in January. Based on a favorable safety review of the results from the first three groups, dosing of patients in the 640-microgram group commenced in May, the companies added.
The study reported an overall strong antiviral response at 12 weeks, and an adverse event profile that shows substantial tolerability improvement compared with other interferons, the companies said.
According to the companies, side effects were confined to the regular flu-like symptoms and other side effects that are associated with interferon treatment
Treatment in 640-microgram group is ongoing. Final study results will be reported in the fourth quarter, the companies said.