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OctoPlus publishes Phase I Locteron results

14 Mar 2008 - OctoPlus N.V. announced the publication of results from its Phase I study with LocteronŽ, its controlled-release formulation of alfa interferon for the treatment of chronic hepatitis C, in the current issue of the Journal of Interferon & Cytokine Research. In the randomised Phase I trial, the administration of Locteron demonstrated bioactivity over a two-week period and resulted in flu-like symptoms that were less frequent, milder and of a shorter duration in a head-to-head comparison with PEG-IntronŽ, the standard of care used as the control arm in the study.
 
The Phase I results were reported in the Journal of Interferon & Cytokine Research under the title "Novel Controlled-Release Lemna-Derived IFN-alfa 2b (Locteron): Pharmacokinetics, Pharmacodynamics, and Tolerability in a Phase 1 Clinical Trial" (28:113-122 (2008) by De Leede et al.).
 
The Phase I dose escalation study was designed to evaluate safety, pharmacokinetics and biomarker response of Locteron in comparison with PEG-Intron in healthy volunteers. The results show that Locteron, given as single doses to healthy volunteers, was well tolerated and safe. They confirm a gradual release of alfa interferon after injection, thus avoiding both high peak and low trough plasma levels. Flu-like symptoms among the groups receiving Locteron in the study were reported to be less frequent, less severe and of shorter duration than in the subjects receiving PEG-Intron. The pharmacokinetics and biomarker response profile of Locteron support the once-every-two-weeks dosing regimen of this product.