OctoPlus hepatitis C treatment found to be effective

The study results showed that patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for the currently marketed pegylated interferons and for a development-stage product, Albuferon.

SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial-1) was designed to evaluate four different doses of Locteron, 160, 320, 480 and 640 micrograms (ug), administered once-every-two-weeks in combination with ribavirin administered orally twice per day in 32 treatment-naive hepatitis C patients with the genotype-1 variant of the virus.

The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus, was 100% in the 640 and 480ug dose cohorts and 88% in the 320ug dose cohort, compared to 37.5% in the 160ug dose cohort. The results compare favorably with results previously reported in clinical trials for the currently marketed pegylated interferon alfa products and for Albuferon for which EVR rates ranging from approximately 74% to 90% in clinical trials have been reported.

SELECT-1 results demonstrated that Locteron was well tolerated at all doses. Approximately 90% of adverse events were rated as mild. There were no serious adverse events in the 160, 320, and 480ug dose cohorts. Injection site reactions were reported in 41% of the patients in SELECT-1.

OctoPlus is co-developing Locteron with its partner Biolex Therapeutics.