Locteron completes Ph IIa HCV trial

OctoPlus NV, a Netherlands-based drug-delivery and development company, says that it has successfully completed a Phase IIa clinical study of its lead product candidate Locteron (controlled-release interferon alfa) in the treatment of chronic hepatitis C. The study examined four different doses of the drug (160mcg, 320mcg, 480mcg and 640mcg) in chronically infected patients.

The results showed that an average 4 log reduction in viral load was achieved with the three highest doses, while subjects in the lowest dose group saw a mean 1.8 log drop. In addition, an early virologic response, a minimum two log reduction in viral load, was seen in 38% of patients in the 160mcg dose cohort, 88% of those given the 320mcg dose, and all patients in each of higher dosage groups, respectively.

OctoPlus said that the findings were significant as they compare favorably with currently, marketed pegylated interferon alfa products. The firm added that it is on schedule to begin a Phase IIb trial in the first half of 2008.