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. Interim data from the Phase III ENSPIRIT trial of the second-generation antisense inhibitor of serum clusterin mRNA as second-line treatment of non-small cell lung cancer (NSCLC) are expected by year end.
From here: http://www.biocentury.com/dailynews/clinical/2014-04-28/oncogenex-falls-on-phase-iii-crpc-miss
Athersys Inc. (NASDAQ:ATHX) fell $1.40 (51%) to $1.33 on Monday after reporting interim data from 88 patients showing a single IV infusion of MultiStem missed the co-primary endpoints in a Phase II trial to treat moderate to severe ulcerative colitis (UC). MultiStem did not improve endoscopic scores from baseline to week eight and did not improve Mayo rectal bleeding subscores from baseline to weeks four and eight vs. placebo. Partner Pfizer Inc. (NYSE:PFE) conducted the double-blind trial, which enrolled patients with moderate to severe active UC despite prior treatment with corticosteroids, immunosuppresants or tumor necrosis factor (TNF) inhibitors. Pfizer has rights to develop and commercialize MultiStem to treat inflammatory bowel disease (IBD), including UC.
MultiStem is also in Phase II testing to treat ischemic stroke and Phase I testing for acute myocardial infarction (MI) and graft-versus-host disease (GvHD). The product comprises allogeneic multipotent adult progenitor cells (MAPC) obtained from the bone marrow of healthy adult donors
From here: http://www.biocentury.com/dailynews/clinical/2014-04-28/athersys-falls-on-multistem-uc-miss
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