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news.Biopharmaceutical firm OctoPlus has reported the commencement of a phase IIa study with Locteron, its controlled release formulation of alfa interferon for the treatment of hepatitis C.
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OctoPlus believes that Locteron has the potential to induce fewer side effects, improve patient compliance and provide a more convenient once every two weeks dosing schedule compared with current therapies.
Locteron combines OctoPlus' PolyActive drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus' co-development partner Biolex Therapeutics.
Results from the phase I study showed that Locteron is both safe and successful in producing a gradual release over two weeks of alfa interferon after a single injection.
The phase IIa study is designed to evaluate Locteron in combination with the anti-viral drug ribavirin in previously untreated chronic hepatitis C patients. The trial will evaluate a range of up to four doses of Locteron administered every two weeks in combination with ribavirin. Viral response, safety and tolerability of Locteron will be assessed.
Results from this study are expected mid-2007 and will be used to select the optimal dose range to be tested in a subsequent phase IIb study.