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Immune Pharmaceuticals, Inc. Message Board

  • stockvet stockvet Sep 5, 2009 11:01 AM Flag

    AZIXA (3 of 3): Phase 2 Monotherapy Study in Glioblastoma Multiforme

     

    SMART MONEY STARTED TO MOVE INTO EPCT LAST WEEK.

    SMART RETAILS SHOULD FOLLOW SMART MONEY AND GET IN AT THESE BOTTOM PRICES FOR A RIDE OF ONCE IN A LIFETIME !!

    GLTA.

    Disclosure: EPCT long, please do your own DD.


    Status: Ongoing, Recruiting Patients

    This is an open-label, multiple-dose study in subjects with glioblastoma multiforme. The primary endpoint for this study is 6-month Progression Free Survival (PFS) compared against historical control. The secondary endpoints include overall response observed over a maximum of 18 months of follow-up and overall survival. This study is being conducted at 10 sites in the US.

    Visit clinicaltrials.gov for more information:

    http://www.clinicaltrials.gov/ct2/show/NCT00892931

    This topic is deleted.
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    • They've changed the protocol in a number of ways. Now it's not 6 mths pfs but a determination of the pfs. There have been a bunch of other modifications too which add up to the target sample having failed more treatments than previously. What to make of this? Maybe they were finding it difficult to get patients or maybe they had to angle for 2nd or 3rd line treatment because Azixa didn't stack up against the other treatments? Have a look and see what you think; here is the list of most recent changes:

      http://clinicaltrials.gov/archive/NCT00892931/2009_06_04/changes

      • 2 Replies to smithofborneo
      • Smith:

        The protocol specifically now mentions "Be HIV positive".

        The AIDS lobby is one of the strongest and if they get behind this drug then EPCT has a effective political ally.

      • I've just had a look at all the stuff on the Azixa trials on the myrx website. There is very little objective response reported among Azixa treated patients. Have a look and see if you can find anything significantly positive among the responses.

        I don't think the recent increase in interest in epct has to do with azixa. I think it is all about Ceplene. The endorsement in the article from the emea gives confidence that Ceplene will sell, if it hasn't already begun doing so. This will represent a fundamental change in epct. It will have a sustainable income stream and become a proper company paying its way with sales of a product.

    • DD done - strong buy!!

      Root

    • As for the efficacy in the phase I, I'll be back on that. (My memory, the nearly none existing, says that the efficacy were more than stable disease in the webcast I refered to.)

      Just logical resoning here:

      Add to that said in the earlier post the start up of a new phase II against primary tumors. Expensive if there is no effecacy in the ongoing trials.

    • By the way, I understand that Temozolomide is just about the only drug proven to work at all with brain cancer.

    • I listened to that one too and agree that Adrian Hobden, the CEO, did point to some positive things about the trials beyond stable disease, but from the posters on the Phase 1 trials stable disease is the best you can find. I'll try to listen to Hobden's presentation again to see if there is anything substantive there.

    • Hi Lars,

      Thanks. That is much more hopeful! It would be great to get some confirmation of that in the upcoming conferences. The real confirmation though would come in terms of a move in myrx's stock price which has not moved in recent weeks and is ridiculously low if Azixa really does work.

      For the benefit of others, here's the translation of your message:

      "Gunnar Mine 09-05-06 18:17:43 Report Post

      How have you there with the webcast from Myriad?

      I had not seen the change in Myriad's website. There is a presentation at AACR two weeks ago on Azixa and combination therapies against human brain tumor cells implanted in mice. Slides with images page after page. Do we get these results in Phase II, we are already rich. :-) The results show "complete inefficiancy of tumor growth", according to author lectures on webcast. Mice and humans, we have these results in humans?

      Our muttering rapporteur says, if you listen closely, the study of metastases in the brain (the major diagnosis with 170 000 patients per year), that patients' Stabel disease or partial response "in" over 50% "of patients. Temozolomide is the name of the combination medicine. Azixa allows the patient does not develop resistance to it and that it may appear more concentrated in only the brain. (Myriad, other techniques to reduce the side effects of medication, an area that streamlines dosgivningen.)

      You read about this study:

      http://www.myriad.com/research/azixa-cli ...

      The study was extended in December -08:
      http://clinicaltrials.gov/archive/NCT006 ...
      "This trail is continuing," according to the rapporteur of the Myriad.

      The change of dosage - more Azixa and less temozolomide-occurred in September -08:
      http://clinicaltrials.gov/archive/NCT006 ...

      Testing has rolled in three quarters of new doses. Looking at trends? Yes, as above: "Stabel disease" and, even better, "partial response". Over time, this may provide even stronger response as a given graph of the patient population. "

    • Can't find it - it's gone of the website. We might have to wait till the Rodman and Renshaw conference late this week.

    • It would be wonderful if Azixa really did work synergistically with Temozolomide, enabling it to be more effective by preventing resistance. This is implied in the translation but I don't think it can be correct. Is this what you meant to say? We do know that Azixa seems to thwart the cancer's ability to develop a resistance to Azixa, but I've never heard that it prevents the cancer from developing resistance to other drugs too.

      Exciting ideas but without confirmation just flights of fancy.

    • "It would be wonderful if Azixa really did work synergistically with Temozolomide, enabling it to be more effective by preventing resistance. This is implied in the translation but I don't think it can be correct. Is this what you meant to say?"


      Yes, that's what I am saying.

      Our 100% own Crinobulin is another VDA. It enhaces the efficacy of the combination drug. Same story. By the way you have the same outcome (but not process) with Ceplene: IL-2 gives side-effect but do not have efficacy after a while. Together with Ceplene at a 10% dosage IL-2 will have efficacy - again.

    • I wrote this att www.di.se after relistening to the webcast:

      "Gruvgunnar 09-05-06 18:17:43 Anmäl inlägget

      Hur har ni det med webcasten från Myriad?

      Jag hade inte sett förändringen på Myriads hemsida. Det finns en presentation på AACR för två veckor sedan om Azixa och kombinationspreparat mot inplanterade mänskliga hjärntumörceller i möss. Slides med bilder sida upp och sida ner. Får vi dessa resultat under fas II är vi redan rika. :-) Resultaten visar "complete inefficiancy of tumor growth", enligt föredragaren på webcasten. Möss och människor, har vi dessa resultaten på människor?

      Vår muttrande föredragande säger, om man lyssnar noga, att studien mot metastaser i hjärnan (den stora diagnosen med 170 000 patienter per år) har patienterna "stabel disease or partial respons" i "over 50%" av patienterna. Temozolomide är namnet på kombinationsmedicinen. Azixa gör att patienten inte utvecklar resistens mot den samt att den kan verka mer koncentrerat i bara hjärnan. (Myriad har andra tekniker för att minska sidoeffekterna av medicinering, ett område som effektiviserar dosgivningen.)

      Man läsa om studien här:

      http://www.myriad.com/research/azixa-clinical-trial.php

      Studien förlängdes i december -08:
      http://clinicaltrials.gov/archive/NCT00635557
      "This trail is continuing", enligt föredraganden från Myriad.

      Förändringen av doseringen - mer Azixa och mindre temozolomide -skedde i september -08:
      http://clinicaltrials.gov/archive/NCT00635557/2008_09_08/changes

      Testerna har rullat i tre kvartal med nya doser. Ser man tendenser? Ja, enligt ovan: "Stabel disease" och, än bättre, "partial response". Över tiden kan detta ge än starkare svar enligt en given kurva över patientgruppen."

      The translation of the essential part ( " har patienterna "stabel disease or partial respons" i "over 50%" av patienterna.")...is that patients with stabel disease or partial respons (=better) is together over 50%.

      I remember that I was relistening several times. This is of course to be taken for what it is worth. It's my writing the same day as the webcast was held. You can find it May 6th at the adress above, "börssnack", "gruvgunnar".

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