OncoGenex Pharmaceuticals Inc Announces Publication Of Phase I/II Custirsen (OGX-011/TV-1011) Data

OncoGenex Pharmaceuticals Inc announced data evaluating its investigational compound custirsen (OGX-011/TV-1011) in patients with advanced non-small cell lung cancer (NSCLC). These data provide additional clinical evidence for the potential of custirsen, a drug designed to block production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types. The single-arm trial, conducted at 15 sites in North America, evaluated treatment of custirsen in combination with a gemcitabine/platinum-based regimen in patients with previously untreated, advanced NSCLC. Eighty-one patients received at least one dose of custirsen and were included in primary analysis. Key study findings are as follows median overall survival was 14.1 months and progression-free survival was 4.3 months. The one- and two-year survival rates were 54% and 30%, respectively; 12% of patients were still alive at a median follow-up of 41 months (range 38-59 months). 69% of patients had a clinical response defined as objective response or stable disease and 31% of patients had tumor responses defined as complete or partial responses. Custirsen treatment decreased serum clusterin levels in 95% of patients evaluated. In addition, patients who achieved a threshold minimum serum clusterin level of < / = 45 mcg/mL had a median survival of 27.1 months compared to 15.6 months for patients who did not.