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OncoGenex Pharmaceuticals, Inc. Message Board

  • mr_ssssamsa mr_ssssamsa Nov 4, 2010 10:54 PM Flag

    Phase 2 bladder trial for 427

    This was the main news today. Does anyone know if this trial could, if the results are strongly positive, suffice for registration? It's randomized, involves 180 patients in 3 arms (using 2 different doses of 427 alongside the control arm), and unlike the 72-patient prostate trial for 427, is multi-center, with planned trial sites in the U.S., Canada, and Europe. I've noticed that ONXX plans to submit Carfilzomib for approval in myeloma based on the results of a phase 2 trial that wasn't even randomized.

    Maybe the above is just wishful thinking, but if true it would mean OGXI could potentially bring 427 to market on its own. They would still have to pay ISIS a modest royalty and would probably have to get a distributor, at least ex-US, but they'd keep the lion's share of the profits. If that's the plan or hope, then it might explain why they made no mention today, as they did previously, of seeking a partner for 427. It could also explain why they did the financing now instead of waiting -- it allows them to start this trial sooner.

    Of course, it would still mean that meaningful trial results are a long way off, and who knows what the pps will do in the meantime. The start of the P3 lung trial for 011 is now slated for "2011" instead of "early 2011," although Cormack said they'll provide more specifics as soon as they agree on the protocol with Teva. And they seem to be holding off on advancing their other pipeline products, though he did say they're in talks with potential licensees for SN-2310.

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    • I doubt it. This is a first-line treatment for metastatic bladder cancer. Not all options are exhausted yet. I did a little bit of research. Assuming that this will be against a cisplatin-based regimen in the first-line setting, I dont see how FDA can approve this over other single agents (vinflunine, pemetrexed) and combos such as trastuzumab and bevacizumab through a single P2 trial.

      However, if OGX-011 succeeds, they will have enough money for a P3 trial for 427 without a partner anyway.

      If OGX-011 fails, 427 will need to be partnered. However, it would cushion the fall somewhat as the co will have $20-30M in the bank and probably $20-$30M for 427 as an asset in a P2 trial. So maybe a 60% fall vs a 80% fall which reduces the risks.

      http://clinicaltrials.gov/ct2/show/NCT01188187 still not recruiting.

      • 1 Reply to summer2762
      • Summer, you are probably right, but since this trial will involve 427 in combination with "standard chemotherapy" (according to the PR -- I don't think he said in the CC which chemo agent it will be), isn't it possible that if one or both of the 427 + chemo arms significantly outperform the chemo alone arm they could approach the FDA about approval? Especially if, as Cormack said and I've heard elsewhere, the existing options for metastatic bladder cancer aren't very effective.

        With regard to the "SYNERGY" trial for 011, I wish one of the analysts had asked him whether there will be an interim analysis.

 
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