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Aeterna Zentaris Inc. Message Board

  • noidlikemine noidlikemine Feb 6, 2014 6:35 PM Flag

    P2 prostate study delayed

    clinicaltrials dot gov was updated today. The 108 p2 trial for prostate cancer which used to have a preliminary data date of 11/2014 has been changed to 11/2015.

    Another year of delay and slow enrollment...

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    • I think AEZS has little control over this trial. In any case they are not spending any money over this. From their website "Phase 2 portion of the trial is supported by a three-year US$1.6 million grant from the National Institutes of Health to the lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center".

      • 1 Reply to sprypoke
      • It isn't that AEZS made a decision. It is more the trend. The bladder cancer study was being run by Miami. Both the bladder cancer and the triple negative breast were halted due to slow recruitment... now the prostate study is being delayed a year for the second time, also presumably due to slow recruitment.
        It is just a bit concerning that they cannot find recruits for any of these studies if 108 is so hopeful.

        Granted, they were all small studies with minimal funding and only running in one or two centers... but still. At least endometrial is in over 80 centers already...

    • ...old news that was posted on this MB back on Jan 16....

      Sentiment: Hold

    • I am not sure it matters anymore. They would not move the trial forward to phase III anyway. Everything depends on the Phase III trial in endometrial now. They will have a good handle on how it is proceeding internally.

      The interesting thing is that they are presenting at the upcoming conference on the role of AEZS-108 in triple negative breast cancer.

      Sentiment: Strong Buy

      • 1 Reply to doxconjugator
      • I agree that if endo fails it is over. But... if the prostate cancer study completed in November (ie 9 months from now) and had positive results, it would have been a good boost and perhaps allowed for dilution at higher prices.

        They presented a paper late last year on the bladder cancer study and then halted it... I'm not sure I would attach much significance to them presenting papers/conferences. (I believe the paper was just a case study of Chambers, but it was odd to present years after the fact and not have any other data...)

        82 sites are now open for the endometrial trial. If they have 80+ patients (averaging just one per site... I assume some that have been open for a while might have more, while some of the newer ones might not have any), then in a few months they should have a decent idea. It is open label...

        If there isn't any serious upwards price movement by the end of the summer, I would get worried (of course, there could be upward movement in the summer in anticipation of the FDA's response to the NDA in November...)

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