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Immune Pharmaceuticals, Inc. Message Board

  • myrxxx4u myrxxx4u Jan 21, 2010 7:49 AM Flag

    !!Great news: Epicept included in guidelines AML!!

    EpiCept's drug Ceplene is included in the AML group swedish guidelines for maintenance treatment of AML.

    Page 28

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    • Hey! Swedish is not as difficult as might be thought for us English speakers:

      "Tack för dina synpunkter. Låt oss hoppas på en positiv lösning."

      Indeed...Låt oss ALL hoppas på en positiv lösning!


    • It seems to me that Epicept should contact the group that publishes the guidelines and ask them for a clarification statement. The fact that we are discussing the guidelines both here and at Avanza indicates to me that the original statement is not clear and the group needs to issue a clarification. If we are confused, then the doctors and patients will also be confused.

    • Jag har egentligen inget nytt att tillägga i sak. Skulle jag kort sammanfatta min uppfattning ogillar jag såväl inledningen som avslutningen på detta citat:

      "...eventuell underhållsbehandling med Ceplene® +
      Proleukin® i första hand bör ske inom ramen för ovan nämnda fas IV studie."

      Tack för dina synpunkter. Låt oss hoppas på en positiv lösning.

    • There is a move south in Sthlm, because of these guidelines. The interpretation from different posts seems to be running in different directions: Those who are content that there is one page where Ceplene is mentioned and another one, stating that the use of Ceplene is more or less restricted to be used in the running phase 4 trial.

      Even if you are Swedish spoken it is hard to interpret the text in just one way. My own interpretation, just reading the text, is that the text signals that there will be new guidlines later, until then the phase 4 trail is the main path. That is, in Sweden.

      "Ingen konfirmerande fas III studie har genomförts, men en fas IV studie ägnad att närmare
      undersöka effekten av IL-2 + histamin på MRD och T-cellsfunktion pågår (2009-2011) i Europa
      och med svenskt deltagande (se sid 3).
      Baserat främst på ovan nämnda fas III studie godkändes Ceplene® våren 2009 av EMEA för
      underhållsbehandling (i kombination med IL-2) av patienter med AML i CR1 inte aktuella för
      allo-SCT. I Sverige är preparatet ännu inte prisförhandlat, men kan för närvarande erhållas
      via läkemedelsföretagets (EpiCept) ”named patient program”.
      Mot bakgrund av ovanstående anser vi att eventuell underhållsbehandling med Ceplene® +
      Proleukin® i första hand bör ske inom ramen för ovan nämnda fas IV studie."

      The translation and interpretation of "i första hand" is of course also crusial. The expression also makes it possible to use outside the ongoing trial before changing the guidelines.

      The next, latest, date for review of these guidelines is in two years: "Gäller fr o m 2010-01-01 Uppdateras senast 2011-12-31"

1.89+0.02(+1.07%)Dec 24 12:58 PMEST

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