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ImmunoCellular Therapeutics, Ltd. Message Board

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  • fansteman fansteman Nov 26, 2012 3:54 PM Flag

    IMUC vs. NWBio

    Yes, I have. Strangely, they only give information about the number of clinical trial sites involved (to date in the US and planned overseas). No patient numbers!

    I also went through their entire thesaurus of press releases related to the trial: In short, the trial posted first in Dec 2006 on clinicaltrialsdotgov, started as an open, randomized phase II with no placebo and a targeted sample size of 140 patients. In a press release dated Feb 13, 2007 they announce the first two patients enrolled undergoing surgery in Detroit. On March 7, 2007 UCLA was added as a second trial site, nine further sites pending. Then, sometime later (could not establish the exact time nor the number of patients enrolled until the trial was halted) the trial had to be stopped due to large number of patients dropping off who had been randomized to no active treatment. They went back to design a placebo process and redesigned the trial as a placebo-controlled phase II with n=240 pats, resuming activities in 2009. On Jan 24, 2011 (about 2 years after the trial had recommenced as a placebo trial) the company announced that "to date" 13 sites are open and active with a total of 33 patients enrolled. In May, four months later, in another press release NWBio announces the addition of further sites and reconfirms the 33 patients enrolled at that time. In a press release from May 25, 2011 NWBio announces the "acceleration" of the opening of new trial sites expecting to have "a total of 10 clinical trial sites for new (sic!) enrollment...within this calendar quarter" and "5 further sites are anticipated to be added in the 3rd quarter". On Aug 4, 2011 "Now 12 sites across the US open and active" (which appears to be in contradiction to the number given at the beginning of 2011, imho). Oct 6, 2011: 17 sites open and active, expecting to have 25 sites by year end. Jan 9, 2012 25 open and active sites, expecting to have at least 30 by end Q1/2012. Feb 23, 2012: 30 US sites open and active, expecting at least 40 open and enrolling by the end of Q2/2012. May 17, 2012: 41 US sites open and recruiting, expecting to have at least 60 by end Q3/2012. In this amendment they also report on the up-grade to a phase III trial with n=300 (up to) and an interim analysis for efficacy (no information as to what triggers this interim). Aug 23, 2012: Still 41 US sites, looking at Europe (particularly UK and Germany) for the addition of further trial sites.

    In an S1 SEC filing dated Oct 31, 2012 they still have 41 US centers open and active, do not give patient numbers and state the ambition to go up to "80 or more" centers in the US and Europe.

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