OncoGenex falls on Phase III CRPC miss
OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI) fell $5.85 (60%) to $3.85 on Monday after the company and partner Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said first-line treatment with IV custirsen ( OGX-011) plus docetaxel and prednisone missed the primary endpoint in the Phase III SYNERGY trial to treat metastatic castration-resistant prostate cancer (CRPC). Once-weekly IV custirsen plus docetaxel and prednisone did not improve median overall survival (OS) vs. docetaxel and prednisone alone (23.4 vs. 22.2 months, p=0.207) in the 1,022-patient, open-label trial.
Next half, OncoGenex and Teva plan to complete enrollment of about 630 patients in the Phase III AFFINITY trial of custirsen as second-line treatment of CRPC. The first interim futility analysis of the Phase III ENSPIRIT trial of custirsen as second-line treatment of non-small cell lung cancer (NSCLC) is expected by year end. The product is a second-generation antisense inhibitor of serum clusterin mRNA. ...