Locteron achieves 100% EVR in SELECT-1 trial

Encouraging results from USA-based Biolex Therapeutics' SELECT-1 Phase IIa trial of Locteron (interferon alpha controlled-release) were presented at the annual meeting of the European Association for the Study of the Liver, in Milan, Italy. Patients on the drug achieved early virologic response, defined as at least a two-log reduction in hepatitis C virus, which was 100% in the 640mcg and 480mcg dose cohorts and 88% in the 320mcg dose cohort, compared to 37.5% in the 160mcg group.

In the trial, average viral reduction after 12 weeks of treatment ranged from 4.7 to 4.2 logs for the 640, 480 and 320mcg doses, compared to 1.8 logs for the lowest dose of 160mcg. Locteron was generally well tolerated at all doses. There were no serious adverse events in the 160mcg, 320mcg and 480mcg cohorts. There was one serious adverse event in the 640mcg arm, a case of inflammation of the ear, which resolved. According to Biolex, Locteron is designed to improve patient care through a more favorable side effect profile compared to existing pegylated interferon products and Albuferon (albumin-fused interferon), each of which lack a controlled-release mechanism. The agent utilizes PolyActive, a controlled-release drug delivery technology developed by Dutch firm OctoPlus, which is also the development partner for Locteron.