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OncoGenex Pharmaceuticals, Inc. Message Board

  • summer2762 summer2762 Jan 31, 2012 8:48 PM Flag

    P2 Results

    Comparison of OGX427 & Abi & MDV3100 using their p1 & P2 trials in

    [1] http://jco.ascopubs.org/content/26/28
    [2] http://jco.ascopubs.org/content/28/9/1496.full
    /4563.full
    [3] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2948179/
    3a: Prechemo patients in [3]
    3b: All patients in [3]
    [4] http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=116&abstractID=89350


    Patients:
    Patients with CTC >=5
    [1] Zytiga trial prechemo: ?
    [2] Zytiga trial postchemo: 69%
    [3a] MDV3100 trial prechemo: 26%
    [3b] MDV3100 trial postchemo: 40%
    [4] P&OGX427+P trial: 91%

    (Which kinda indicates that patients in Zytiga & MDV3100 trials might have been healthier compared to the patients in OGX427 trial)

    PSA median
    [1] 51
    [2] 189
    [3a] ? (<50 most probably)
    [3b] 50
    [4] 89


    Results:
    >0% decline at 12week
    P: 40%
    Zytiga+P: ? [1]
    Zytiga+P: 58% [2]
    MDV3100: 77% [3a]
    MDV3100: 72% [3b]
    OGX427+P: 82%

    >30% PSA decline at 12week:
    P: 20%
    Zytiga+P: 66% [1: Max; not at 12week]
    Zytiga+P: 47% [2]
    MDV3100: 71% [3a]
    MDV3100: 42% [3b]
    OGX427+P: 55% [4]

    CTC Conversion:
    P: 20%
    Zytiga: ? [1]
    Zytiga+P: 34% [2]
    MDV3100: 75% [3a]
    MDV3100: 51% [3b]
    OGX427+P: 60% [4]

    Notes:
    OGX427 study needs more patients. 1 patient making 10% difference is not something to be proud of.

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    • Thanks for pulling that together. Clearly they need more patients but the differences between the 11 in the 427 + prednisone group and the 11 in the prednisone only group are pretty substantial and would appear not to be due to chance, even if it will take a larger sample to show that statistically. The small sample also makes it hard to meaningfully compare the results to the Zytiga and MDV 3100 trials but at least so far 427 seems to be in the ballpark with them, which is better than I was expecting. The panel discussion should be interesting.

      • 2 Replies to mr_ssssamsa
      • Bottom line is this is as good a signal someone can get from 22 patients considering that for the primary endpoint, ogx427's 82% is numerically better mdv3100's 77% which is now $61.75 in AH (market cap > $2B). Especially important fact is that the patients in the ogx427 trial were sicker than those in MDV3100 trial.

        Will Mr. Scott Cormack be able to convince a partner spend $$$ to run a P3 using 22 (or soon 32) patients. I dont know. Does he have another choice (like running a proper P2)? I dont know.

        Lets see how good he is (no pressure) :)

        Sometimes, it's good to be just investors.

      • BTW the P1 bladder results were nothing to sneer at either, with 5 of 13 patients achieving complete responses. Further evidence that 427 is an active drug, which now has to be viewed IMO as a significant part of OGXI's product portfolio.

        And it's a drug that has shown the potential to treat a host of cancers, including ovarian, pancreatic, and lung, so if OGXI wants to maximize its value it's probably going to have to partner.

        The other possibility, which I hesitate to mention since it's such a staple of biotech board posts yet so rarely happens, is a buyout. That was unlikely as long as all the focus was on 011 because Teva stands to collect most of the 011 profits but when you factor in the unpartnered 427 franchise it's less farfetched. It was mostly rumors of a possible buyout that propelled the stock over $40 in 2009. Since it seems to be buyout season in biotechland, maybe it's time to start those rumors again. With 011 advancing towards the finish line and 427 beginning to prove its mettle, I would think the company is worth a lot more now than it was in 2009. Just a thought.

 
OGXI
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