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ImmunoCellular Therapeutics, Ltd. Message Board

  • phishes3 phishes3 Jun 20, 2013 10:10 PM Flag

    mgmt status in P1

    The MGMT status was known in 10 of the newly diagnosed patients in the P1 trial...
    4 were unmet and their Median OS was 27.3, average OS was 34.5 (patients number 2, 4, 11, and 12)
    6 were met and their Median OS was 44.7, average OS was 44.7 (patients number 6, 7, 9, 16, 19 and 20)
    Info in table 3 in the abstract on the SpringerLink
    60% met which is higher than normal per the other abstracts...
    One could say that this explains part of the reason for the higher OS in the P1... I need to absorb this better...

    Daweasl - we think alike...

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    • Please remember that although one of the numbes I gave was the average OS (because I find this very valuable) - the Fda is focused on the Median and this is where the real difference is...

    • Do we know the occurrence of the promoter over the general GBM population? I'm "guessing" that 60% of those who's status is known in PI is rather high - even if those were the only ones in the 16 total for PI. The quick enrollment for the PII trial, might indicate a presentation that's closer to the average(?).
      I must admit, as I run down the list of pro's and con's with my position here, I'm taking this new revelation rather badly...

      • 2 Replies to evsworld
      • I bought more today. You have a product that is demonstrating efficacy, an Exec who has recently bought shares since the announcement, a product that will be life-changing if proven, and a thumbs-up to continue to proceed with a Phase II trial after interim analysis. A little more on GBM...many patients are not allowed to participate in trials with GBM experimental treatments due to the severity of their disease and/or comorbidities. Such patients normally are not expected to live longer than 6 months. How ICT-107 impacts these patients will be of interest as these patients have few options. Generally, for me, the 13 and 21 month survival advantages depicted in the multiple messages here, are demonstrative of several different trials for patients with GBM treated with Temozolomide pending dosing, patient selection, etc. Results from ICT-107 in the Phase I are extremely high compared to expectations even with active methylation in my opinion.

      • Dec. '06:
        Results The MGMT promoter was methylated in 45 percent of 206 assessable cases. Irrespective of treatment, MGMT promoter methylation was an independent favorable prognostic factor (P

    • At least that rules out them loading PI with MGMT indicators....I think average OS of 34.5 months for non MGMT patients is still a marked improvement, by anybodies measurements.

    • So, based on those stats--if the PI were 50/50 on MGMT methylation (which eliminates it as a factor), you would expect a 36 month average OS instead of the approx 38 month average OS reported.

      That doesn't change my view of the PI data efficacy. It's still a huge benefit.

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