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ImmunoCellular Therapeutics, Ltd. Message Board

  • fansteman fansteman Nov 24, 2013 2:43 PM Flag

    IMUC vs. NWBio

    "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer" - here is in short what I could gather from all press releases pertaining to this trial and from SEC filings by NWBio:

    Q4 2006: Trial starts as an open, randomized phase II, n=140; first IRB approval at Henry Ford Hospital, Detroit in Nov 2006. Study start date (acc. to clinicaltrialsdotgov): Dec 2006.
    Q1 2007: First two patients enrolled undergo surgery in Detroit; UCLA joins as the second trial center
    2008: Trial halted, because too many patients randomized to the control arm (no active treatment) withdraw. NWBio designs a placebo procedure in response.
    Q1 2009: Trial re-starts as a randomized, placebo-controlled phase II trial; n=240
    Q1 2011: 31 US sites open and active; 33 patients enrolled. May 2011: co re-confirms the number 33.
    May 2012: 41 US sites open and active; no new patient numbers. Trial is up-graded to a phase III, n increased to "up to" 300 patients. Planned expansion to Europe and an interim analysis for efficacy (no mention of the trigger for this analysis).
    Oct 31, 2012: S1 SEC filing, 41 US sites open and active, plan to open a total of "80 or more sites in both the US and Europe". No up-date of patient numbers.
    Feb, 2013: Still - only - 41 sites open, "poised to begin recruiting in the UK"… Finally, PAREXEL engaged as global CRO to manage the trial
    Sep, 2013: German authority (PEI) approves trial to start recruiting in Germany with substantial changes to the protocol.

    You may consider IMUC a speculative investment and I wouldn't argue against that. However, their randomized, placebo-controlled phase II trial is fully recruited since early Sept 2012 and we simply have to wait for it to mature and produce the overall survival data sometime soon (Q4'13, Q1'14). NWBio keep everyone in the dark about the true performance of their trial, true accrual numbers. It seems fair, however, to infer from their public statements that they are far from completing recruitment, left aside producing meaningful results….

    IMUC may be speculative, but, at least, we reach the value inflection point any day now. With NWBio, you don't know where they stand at present and results from this trial are out into indefinite future. IMUC, if positive, runs a fair chance even to go straight into filing.

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    • Their trial is #$%$. Primary endpoint of Progression Free Survival instead of gold standard used by IMUC of Overall Survival. Plus a crossover design allowing placebo group to cross over to DCVax potentially confounding the overall survival stats. No wonder why they don't want to update on trial enrollment. IMUC updated every few months on enrollment progress.

 
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