OctoPlus begins dosing in US Locteron study

OctoPlus NV, a Dutch drug delivery and development company, has begun dosing patients in a US Phase IIa trial of its controlled-release chronic hepatitis C treatment Locteron (interferon alfa). The program is designed to expand upon the favorable results achieved in the European SELECT 1 Phase IIa study (Marketletter November 12, 2007), and is being conducted under an Investigational New Drug application previously filed with the Food and Drug Administration.

The study will seek to evaluate Locteron in 56 chronically infected patients at dosages of 320mcg and 640mcg. The first four weeks of the trial will compare the low-dose formulation with Peg-Intron (pegylated interferon alfa-2a; made Schering-Plough), each one being administered in combination with daily ribavirin to patients who have failed to respond to prior therapy. The second phase of the assessment will make a similar comparison using the 640mcg Locteron dose.