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Immune Pharmaceuticals, Inc. Message Board

  • OneBattery OneBattery Feb 22, 2008 9:46 AM Flag

    one pivotal study

    during the last conference call, jack said that the main issue as to whether ceplene will be approved by the emea is whether we meet the guidelines for approval based on one pivotal study. he then said that they have laid out a case for the emea showing them that we fully meet those guidelines, and hence he is expecting a positive opinion.

    in case you are interested in seeing what those guidelines are, click on the below link and scroll down to section III.2 "prerequisites for one pivotal study applications" on the bottom of page 5.

    http://www.emea.europa.eu/pdfs/human/ewp/233099fen.pdf

    i would have loved to have seen the case that jack laid out, but he seemed pretty confident that we "fully met" those guidelines.

    time will tell.

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    • yeah cheers to that they should have a decent quarter with all those diluted shares they srew us on .we shall be rewarded god help us

    • btw, many thanks to everyone who took the time to contribute to this thread...there are some really excellent posters on this board...soon we'll know whether we met those guidelines or not...

    • I think it is a misprint. Two figures are give for the significance of the phase 3 trial effect: p=0.02 or p=0.01 (more or less!). It achieved much greater than the required degree of significance (p=0.05). In ordinary terms, the probability that the findings of the trials were real and not a fluke was 98% or 99% vs. the required probability of 95%. The findings of the trial were that there was an almost 50% greater number of leukemia free patients in the treated group than in the untreated group by the end of the trial.

      This corresponds to one of the emea's single pivotal study requirements that efficacy be considerably or much more certain than the minimum required.

    • from the epicept website:

      Phase II Clinical Trial
      A Phase II investigator trial was conducted in Sweden in which 39 AML patients in complete remission were treated with various combinations of Ceplene and low-dose IL-2. The objective of the study was to determine a Ceplene plus IL-2 treatment regimen that would have the least negative impact on normal living for patients in remission, and to determine the feasibility of using that regimen in a larger study of AML patients in complete remission in a long-term, at-home, self-administration clinical trial. Some patients were treated with chemotherapy as well as Ceplene and IL-2 therapy.

      Results of the first 29 patients enrolled from this investigator trial were encouraging: of the 18 patients in their first complete remission 67% remained in complete remission (median 23 months follow-up), and of the 11 patients in their second or later complete remission, 36% remained in complete remission (median 32 months follow-up). The trial results also demonstrated that the regimen of Ceplene 0.5 mg and IL-2 1 µg/kg administered subcutaneously at home was safe and well tolerated by most subjects. The results of this study led to the development of the Phase III protocol MP-MMA-0201.

    • Will do. I also e-mailed Robert and asked him on any info in previous ceplene trials for aml. Will post it if i get a reply.

      What was the outcome of the 39 patient pII? Anything that might be concerning to the EMEA?

      TIA

    • must be a mis-print, I only know of 2 trials in AML 39 patient ph2 and 360 patient ph3

      I had found many similar comments in my digging related to the Melanoma trial.

      Please dig and let me know!!

      Thanks!!

    • "Ceplene’s failure to meet the primary endpoint in the earlier AML clinical trial threw in the first significant monkey wrench to launch plans, noted analyst Kate Winkler with Merriman Curhan Ford & Co. in a recent report on the company. "

    • I don't see what you are saying...the verbage is tricky, but it refers to the Melanoma trial

      The first signs of trouble for the drug surfaced last year. Results announced in September 2004 showed Ceplene failed to meet its primary endpoint in a Phase III clinical study that tested the drug in combination therapy with interleukin-2 (IL-2) antibody.

      I do not see where it says AML

      To the best of my knowledge, there was only 1 Phase 3 AML trial conducted. They were asked for another confimatory inregard to the IL2 issue.

      Please correct me if I am wrong about this.

    • Thanks to you too.

      I agree with what you say. It's a wacky world where a govt. body doesn't allow a harmless drug which effectively treats an otherwise untreatable and deadly condition.

    • Just found an interesting article which says Ceplene failed to meet the primary endpoint in previous AML trials:

      www.icis.com/Articles/2005/02/18/653166/maxim-faces-further-obstacles.html

      Has anyone seen any data from PII trials?

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