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Immune Pharmaceuticals, Inc. Message Board

  • larshansson18 larshansson18 Oct 6, 2011 4:24 AM Flag

    Triggers for Q4

    There are some news to prevail under Q4, most of them depending on other actors than Epicept alone:

    The investigators publication of the results from the phase IIb trial in CIPN, pain in cancer and cancertreatment, especially breast cancer.

    The end of phase II-meeting with FDA concerning the future Amiket trial design for phase III. The basic ground for the deal with one of the Big Pharmas interested in a deal for the BUSD market of neuropathic pain.

    The meeting with FDA concerning the SPA for the phase III trial of Ceplene in the USA. (Here I am interested in knowing how many test there have to be to let LFS replace / constitute OS.) The SPA c o u l d be a condition for an alternative way of financing Epicept. I'll be back on the issue of the possibillity for a positive outcome of the trial. It seems very good, acctually.

    Crolibulin will present phase I-results on safty and a quick glance at the efficacy from the investigators. Will we see a trend change for the VDA's. Positive results here will impact many of the biotechs having this kind of molecules. We know Crolibulin is special, but h o w special, time for some results giving impact not just on the tumors, but for the patients helth. Time will tell, if we have some stable diseases here.

    Meda continues the work in the EU for reimbursement and after that launch of Ceplene in the rest of the countries in the EU. National guidance for AML will be changed in this process.

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    • Today we got this example on the board on my last paragraph, the Meda work on Ceplene in the EU. In Sweden we have just changed the ownership balance between the private and stateowned Pharmacies. Most are still publicly owned, this is there take on the new treatment for maintainance ("Underhållsbehandling") for AML:

      ""Terapirekommendationer – Akut leukemi


      AML Daunorubicin (idarubicin) + cytarabin (vid akut promyelocytleukemi tillägg av tretinoin)
      ALL Olika protokoll till barn och vuxna, beroende på sjukdomens fenotyp och riskgrupp. CNS-profylax.


      AML 2–3 behandlingar med samma beståndsdelar som vid induktion, med minst en innehållande
      cytarabin i högdos (inte vid APL)
      ALL Olika protokoll – se även underhållsbehandling

      (ej APL)

      Immunterapi med histamin/IL-2 (efter fulldos konsolidering) kan övervägas

      APL 2 års behandling med merkaptopurin (dagligen), metotrexat (1 gång i veckan) och
      tretinoin (14 dagar var 3:e månad)
      ALL 2 års kombinerad underhålls- och konsolideringsbehandling (olika protokoll). Merkaptopurin och
      metotrexat ingår oftast enligt ovan. Här används även s k sen intensifiering med parenterala cytostatika."

      This is after price regulation and reimbursement, but before a definit change of the national guidelines. :-)

    • "
      27-Oct-09 05:25 am

      I am open with my business plan here. I have got quite a big investment here. Some million SEK.

      You are a big loser, 2 years ago the swedish share price was about 17 SEK, today 2 SEK,
      that's - 88 %

      Why not change your swedish nickname to Ceplene ??

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