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Celsion Corp. Message Board

  • clsn_bounce_starts_now clsn_bounce_starts_now Jun 10, 2013 8:43 AM Flag

    In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients), Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only.

    In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients), Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only.

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    • trillium44@sbcglobal.net trillium44 Jun 11, 2013 2:48 PM Flag

      DC is in the HOUSE!!!!!!

    • Given continued validation of the results for the identified subgroup a couple of thoughts.

      1. CLSN moved to a Ph III trial with very little previous trial experience with their treatment. I do not believe a Ph II trial was ever initiated, and there wasn't much either in Ph I. Amongst other things, this would seem to have prevented a proper vetting of the best way to construct the Ph III trial. For example, I would equate the current identification of the perhaps meaningful positive results with the procedure lasting longer than 45 minutes to be similar, at least in a general conceptual way, with dose escalation trials that are usually worked out in the earlier trial phases. I realize the timing is not in itself dose escalation, but hopefully you get the point. So, if the 45 + minute treatment does in fact prove to be a consistent result, the fact that the Ph III trial "failed" is more a result of the strategy of their trial development, and not a result of their science. If true, although delayed and diluted, very positive treatment and financial results are still there.

      2. Having followed ACAD's recent experience with their drug I would note that they recently completed a very successful Ph III trial after two previous PhIII trial failures. It took them three times to design the trial correctly, but once they were able to do that the results were in fact spectacular. A year ago their PPS was in the $1s, yesterday it broke $20, and the drug is still yet to be approved by the FDA. Their previous Ph III trials failed not because of the drug, but because of the trial design. They learned from those failures and corrected the design. CLSN might (might) be similar.

      Purchased more than 40k shares of CLSN back when it was in the $1s before the last trial results. Rode it up to the $8s and back down to the $1s again. All along I was in it for a big hit as it wasn't a significant part of my portfolio. Recently back in, fewer shares & less upside, but still interesting.

      • 2 Replies to paladin_roams
      • Given continued validation of the results for the identified subgroup a couple of thoughts.

        1. CLSN moved to a Ph III trial with very little previous trial experience with their treatment. I do not believe a Ph II trial was ever initiated, and there wasn't much either in Ph I. Amongst other things, this would seem to have prevented a proper vetting of the best way to construct the Ph III trial. For example, I would equate the current identification of the perhaps meaningful positive results with the procedure lasting longer than 45 minutes to be similar, at least in a general conceptual way, with dose escalation trials that are usually worked out in the earlier trial phases. I realize the timing is not in itself dose escalation, but hopefully you get the point. So, if the 45 + minute treatment does in fact prove to be a consistent result, the fact that the Ph III trial "failed" is more a result of the strategy of their trial development, and not a result of their science. If true, although delayed and diluted, very positive treatment and financial results are still there.

        2. Having followed ACAD's recent experience with their drug I would note that they recently completed a very successful Ph III trial after two previous PhIII trial failures. It took them three times to design the trial correctly, but once they were able to do that the results were in fact spectacular. A year ago their PPS was in the $1s, yesterday it broke $20, and the drug is still yet to be approved by the FDA. Their previous Ph III trials failed not because of the drug, but because of the trial design. They learned from those failures and corrected the design. CLSN might (might) be similar.

        Thanks to paladin_roams for this post.

      • I'm bumping this to the top. It needs to be read to undeerstand what's going on...thanks to paladin_roams

    • Overall Survival improved by 66%

      There is no other Liver Cancer treatment that can make this claim. NONE.

      • 2 Replies to clsn_bounce_starts_now
      • So answer this. If 40% or 300 patients had a hazard ratio of .602 and OS improved by 66%, if the real stats were truly that good, then WHY IS IT NOT STATISTICALLY SIGNIFICANT. Essentially, this variation can be solely due to chance and not the "optimized RFA" at all!

        With 300 patients they should have been able to rule out chance and be able to claim significance.
        WHY CAN'T THEY?

        And to confound things further, the other 400 patients who had short RFA + TDOX actually had to have done much worse than the control group which further implicates that general randomness is behind the numbers CLSN is touting. There is a reason why CLSN can't show significance of their newly mined data. It's BS.

        Regardless, they will need to fund and run another large study using their "optimized RFA" process and again hope that this data holds and is actually statistically significant when it's done. Anything else is a non starter with the FDA.

      • Overall Survival improved by 66%

        There is no other Liver Cancer treatment that can make this claim. NONE.

 
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