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ImmunoCellular Therapeutics, Ltd. Message Board

  • fansteman fansteman Nov 27, 2012 2:36 PM Flag

    DCVax-L phase III: The History

    "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer" - here is what I could gather from all press releases pertaining to this trial and from the 2012 S1 SEC filing 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.

    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 next year. NWBio keep everyone in the dark about the true performance of their trial. It seems fair, however, to infer from their public statements that they are far from completing recruitment. How else do you explain their stated ambition a month ago to double (!!) the number of active trial sites...

0.214-0.002(-0.93%)2:38 PMEST