Biolex Therapeutics, Inc. announced that interim results from two phase-2b clinical trials of its lead product candidate Locteron for the treatment of chronic hepatitis C have been accepted for oral and poster presentations at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) to be held in Vienna, Austria in April 2010. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care.
The objectives of the two phase-2b trials are to demonstrate viral kinetics and response that is at least equivalent to the PEG-Intron control while also achieving at least a 50 per cent reduction in flu-like adverse events.
The interim results to be presented at EASL are from two ongoing phase-2b clinical trials, the 'SELECT-2' dose-finding trial evaluating the 320, 480 and 640 µg doses of Locteron, and the '480 Study' which is further evaluating the 480 µg dose. Researchers will present the 12-week interim results from these two trials at the EASL conference. The company does not expect to release the results in advance of the presentations in accordance with the embargo requirements of EASL.
“We are pleased that the interim results from the SELECT-2 and 480 Phase 2b trials have beenselected for presentation at this prestigious conference,” said Jan Turek, Biolex’s president and chief executive officer. “These two trials serve to confirm each other, providing us with great confidence in the robustness of the results that have been attained to date. Locteron’s expected product profile was tested in extensive market research in the first half of 2009, and the research results suggested that the potential tolerability and dosing convenience advantages of Locteron supported a substantial commercial opportunity.”
Locteron is a controlled-release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favourable side-effect profile and dosing convenience compared to existing pegylated interferon products.
Biolex is a biopharmaceutical company that uses its patented LEX SystemSM to develop follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies.