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OncoGenex Pharmaceuticals, Inc. Message Board

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  • mr_ssssamsa mr_ssssamsa Feb 12, 2013 10:00 AM Flag

    Metastatic bladder trial for 427

    Agree. Today's PR says "If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 study of OGX-427 in bladder cancer as part of the ORCA program. " Cormack has gone back and forth on whether if the other P2 bladder trial (the first-line trial now called "Borealis-1") succeeds they'd go on to a P3 or just try to file for approval. Obviously it all depends on what the FDA will say, and Cormack has to be careful not to presume they'll give their okay to skipping P3. But this new Boralis-2 trial is a randomized 200-patient trial with participation by Sloan Kettering and Dana Farber so I have to think if the results are positive OGXI's goal will be to file.

    And maybe best of all, unlike Borealis-1 it seems to be fully sponsored (by the Hoosier Oncology Group), so it shouldn't cost OGXI much or change their projection that they have enough cash to last into 2015. (I think that projection assumes they'll launch additional P2 trials for 427 in lung and pancreatic.)

    Definitely a nice, unexpected development that should take the focus away from l'affaire Burris. As Dr. K has said, it's the clinical program and its success that will drive OGXI's pps.

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