Biolex Therapeutics, of Pittsboro, and Octo-Plus, of Leiden, the Netherlands announced preliminary top-line results from the Phase IIa trial, a 12-week study designed to evaluate a range of four doses of Locteron administered once every two weeks in combination with the antiviral drug ribavirin.
"We are pleased to have successfully completed this Phase 2a Locteron clinical trial, and have achieved our objective of identifying multiple doses with an appropriate combination of early viral reduction and favorable tolerability," said Jan Turek, Biolex president and CEO. "We are preparing to advance the product into Phase 2b clinical trials, expected to begin in the first half of 2008."
In each of the two highest dose cohorts of the trial, the combination of Locteron and ribavirin resulted in an early virologic response (EVR) in 100 percent (16/16) of the hepatitis C patients treated. Study results also suggested patients receiving Locteron experienced less frequent and less severe side effects than those previously reported in clinical trials for competitive products.