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news.Biolex Therapeutics has revealed that the first cohort of subjects in the company's phase I study of investigational hepatitis C candidate, Locteron, have been dosed.
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Biolex is co-developing Locteron in collaboration with drug delivery and development company OctoPlus, initially for the treatment of patients with chronic hepatitis C.
Locteron combines BLX-883, a recombinant alfa interferon produced by Biolex in its patented LEX System, with PolyActive, an advanced controlled-release drug delivery technology developed by OctoPlus.
The phase I study is designed to evaluate the safety and pharmacology of Locteron in 27 healthy volunteers. The randomized, blinded, controlled study is being conducted in the Netherlands and will evaluate single administrations of three different doses of Locteron with comparison to controls consisting of the delivery vehicle, a placebo, and PEG-Intron (a currently marketed long- acting pegylated alfa interferon).
Locteron is intended to be administered only once every two weeks, as compared to the once-a-week administration of the currently licensed pegylated interferon products. Locteron will be evaluated in clinical studies in combination with either ribavirin or with any of the next-generation anti-viral drug candidates currently under development for the treatment of patients with chronic hepatitis C.
“We are very pleased to have moved into the clinic with a product candidate designed to address major areas of unmet clinical need in the treatment of chronic hepatitis C,” said Jan Turek, CEO of Biolex.