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news.OctoPlus has started patient dosing in a Phase IIa study in the US with Locteron, its controlled-release formulation of alfa interferon for treatment of chronic hepatitis C. The study is being conducted under an investigational new drug application filed with the FDA.
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The US Phase IIa ‘PLUS’ trial will evaluate up to 56 patients with chronic hepatitis C. The PLUS trial will evaluate safety, tolerability, pharmacokinetics and viral kinetics of Locteron and will provide US investigators first-hand experience with the product. Locteron doses to be evaluated in the trial include 320ug, the lowest dose in the SELECT-1 study to show favorable viral response, and 640ug, the highest dose of Locteron studied to date.
The first phase of the PLUS trial will involve four weeks of treatment and will compare the 320ug dose of Locteron to PEG-Intron, each in combination with daily ribavirin, in a total of 16 chronic hepatitis C patients who have failed prior treatment. The second phase of the trial will also include four weeks of treatment and will compare the 640ug dose of Locteron to PEG-Intron, each in combination with daily ribavirin, in a total of 16 patients who have failed prior treatment. The final phase will evaluate 12 weeks of treatment of 24 treatment-naive patients with the genotype-1 variant of the virus, with patients randomized to receive either the 320ug dose of Locteron, the 640ug dose of Locteron, or PEG-Intron, each in combination with daily ribavirin.
OctoPlus and its co-development partner Biolex Therapeutics plan to commence SELECT-2, a Phase IIb trial with Locteron, in the fourth quarter of 2008. The 12-week results of the Phase IIb trial will be used as the basis for dose selection for the commencement of the Phase III development program.