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Immune Pharmaceuticals, Inc. Message Board

  • alvin_s60 alvin_s60 Jun 16, 2009 3:53 PM Flag

    Azixa phase II results

    Phase 2 Combination Study in Metastatic Melanoma
    Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
    http://clinicaltrials.gov/ct2/show/NCT00609011

    Phase 2 Combination Study in Glioblastoma Multiforme
    Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
    http://clinicaltrials.gov/ct2/show/NCT00635557

    Myriad Genetics is currently conducting Phase II trials for Azixa. If successful these results could lead to Phase III registration trials for the compound, which would trigger a milestone payment for EpiCept.

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    • Good post - do you by chance know the amount of the milestone?

    • ACTUALLY, do you know the TRUE intent of most Phase I studies?

      While a necessary scientific and regulatory step, the primary purpose of most phase I's is to raise money.

    • I wish I could understand that stuff. I need to get a book on understanding pharma...I laughed my ass off when you wrote that phase I is really just a fund raiser, still laughing at that one.

      Jon - I think you should give me an idea of pharma's that you think have promising technologies so I can run numbers on them :)

      Strange day today, seems like we are coming down to more intermediate support, there's no reason for it to move again until there is more news - hopefully the news that emerges won't come from the meeting on 07/02, this will be a scary day for EPCT longs if nothing is released before then.

    • Please do that. If it bucks the odds and indeed holds promise in brain cancer, there is a chance an interesting chain of events could occur.

      Once MYRX trades "regularly" in July then later (perhaps Aug) the melanoma data comes out and in likelihood hammers the stock down, which would be a good buy in point in anticipation of the late 09 brain cancer data.

      Sorry, but as you probably know, the biotech landscape is littered with the bones of failed melanoma candidates.

      Just recently, SNTA failed miserably, the CRGN data was underwhelming (disappointing because its a IMGN ADC compound), and I expect the best shot may be ipi from MEDX due out later this year, but again, low odds.

      The first super solid mab or other to treat late stage melanoma will take the world by storm.

    • OT: Jonaustin and others, I was curious about your thoughts on Celegene (CELG) and Seattle Genetics (SGEN) as far as biotech/oncology companies go?

      If EPCT ever gets its act together, should they emulate these two companies, especially the former, it terms of operations, product development, marketing, partnerships, etc? Celegene is quite successful in this space.

      Thanks in advance!

    • I don't want to get into a detailed discussion of azixa technically, because its inconsequential at this stage in my opinion.

      But previously, I had noted that I was not sanguine as to its prospects. Briefly, in addition to being a VDA, it acts within the AKT pathway to disrupt the microtubule stabilization process (an "MDA") that cells need to multiply. There are similar compounds that utilize this approach in various oncology applications, most notably the EXEL-BMS XL184 reported disappointing PII results in glioblastoma.

      The EXEL preliminary data was also very promising initially, but has begun to fade in terms of response rate. Admittedly, their study had some dosing issues thus one can't compare across trials with much success. My only point is that EXEL is much further along in that pathway (AKT) in glioblastoma and is encountering difficulties.

      Axiza supposedly has "dual" activity as a VDA as well, though that supposed superiority in combination with a MDA approach isn't entirely clear.

      Just getting that out there, I just wanted to offer a grossly oversimplified explanation of why I'm not overly optimistic in its application to glioblastoma and even less so its potential in melanoma.

      Also, in general, you see more success in the acc app/PR path with liquid tumors as compared to tough to treat solid tumors.

    • That's interesting, I will look into it more thoroughly. Some comments:

      1 - More specifically, I believe what you describe, to be more accurate, is accelerated approval which may or may not include priority review. It will depend on the design of the phase II study and the strength of the results as to whether it is eligible.

      2 - While glioblastoma is an unmet need, it isn't totally unmet, given that DNA/Roche just received acc. app. of Avastin for that indication. Whether or not that may mean that azixa would be precluded, or be required to demonstrate non-inferiority, I am not sure at this point.

      3 - I would not assume that the market cap for the new entity MYRX once it actively trades in July will be a billion. They are shares as dividend. Though I did notice that the new entity is being funded with 188 Mill, a significant fact I had missed.

      Thanks for the heads-up, I scanned the MYGN-MYRX info only minimally. It is still too early to determine the net effect to EPCT at this point in time.

    • Thanks Jon!

      I will look into it, but I think Azixa has one big advantage over the other compounds that is its highly brain penetrant cytotoxin which also selectively disrupts tumor vasculature.

      They are both targeting patients with and without CNS metastatis.

    • jon

      If the phase II data is positive then they will file for a NDA at the FDA with a fast track status to speed the review process and it could hit the market as early as late 2010. Let's see the outcome of the phase II data first and so far the data looks really promising.

      By the way it's interesting to see that the market cap for Myriad Pharmaceuticals ("new company") with just three compounds in clinical trials in their product portfolio Azixa phase II, MPC-4326 phase II,MPC-3100 phase I is a billion dollar.

      "Shareholders of record of Myriad Genetics will receive a pro-rata dividend of 1/4 share of Myriad Pharmaceuticals common stock for each share of Myriad Genetics common stock,The common stock is expected to begin "regular way" trading under the ticker symbol MYRX at the start of trading on July 1, 2009"


      Link to their "new" homepage
      http://www.myriadpharma.com/public/about.html

    • correction: CRGN's melanoma drug is a SGEN compound, not IMGN.

      For those interested, today's announcement by IMGN of a share offering is not surprising and perhaps a good buy point post the dilution dip tomorrow, if you are looking for long picks.

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