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Immune Pharmaceuticals, Inc. Message Board

  • larshansson18 larshansson18 Feb 17, 2011 1:51 PM Flag

    NP-1 ready for the broad neuropathic pain diagnosis

    I wrote this in Sweden today, please use some translate program:

    A short summary: The prolonged efficacy week 5 and 6 (at a total p-value of .001) gives us a strong statistical signal that a phase III in the broad, whole diagnosis of neuropathic pain will be a successful.

    "Epicept har fått en dörröppnare.

    Skrev detta på B S nyss:
    "Epicepts VD har just betonat något sensationellt under sin webcast.

    Resultaten från NP-1-studien mot neuropatisk smärta vid cancer och cancerbehandling hade sensationellt starka värden: FDA kräver en säkerhet om 1:20 att det inte är slumpen som styr resultatet (”p-value om 0,05”), NP-1-krämen visade en statistisk säkerhet om 1:1000 att slumpen orsakade resultatet (p-value om 0,001). Detta är nämnt och känt.

    Vad som inte är kommenterat är de fakta från studien som VD presenterade på webcasten: krämen ger mer verkan för varje extra vecka som behandlingen förlängsefter 4 veckor. Detta var en signifikant iakttagelse. (Fas IIb-studien behandlade patienterna under 6 veckor.)

    Här är den viktiga förklaringen:

    Epicept har för två år sedan gjort en fas II mot h e l a diagnosen neuropatisk smärta. Den studien hade en 4 veckor lång behandling med ett p-value om 0,07, inte de 0,05 som var nödvändiga för FDA. Bolaget antydde att det troligen skulle bli bättre resultat om man förlängde behandlingen. Patientgruppen är enorm och innefattar bl a diabetikers smärta. Diagnosen omsätter c a 5 mrd USD per år i USA.

    Det viktiga med resultatet från den nya studien vid cancersmärta är att den visar att en fas III-studie mot h e l a den s a m l a d e diagnosen neuropatisk smärta kommer att lyckas med bred marginal, om just behandlingen förlängs till 6 veckor.

    Dessutom visade man nu med signifikans att det inte fanns några bieffekter av krämen andra än de placebos gel gav.

    Att en fas III studie med mycket stor statistisk säkerhet går att få hem för h e l a diagnosen neoropatisk smärta är sensationellt. Dessa nya data tror jag ger en uppgörelse marknaden helt har underskattat.

    Frågan är om inte NP-1 efter dessa nya data har, som det nu ser ut, ett avgjort större värde för Epicept än dess redan godkända cancermedicin, Ceplene. Ja, kanske t o m vid godkännanden för Ceplene i nya diagnoser för andra blodcancerformer.

    NP-1s starka resultat gör att de nu p g a dessa resultat får förnyade kontakter med de som vill köra NP-1 för h e l a diagnosen neuropatisk smärta, inte bara en deldiagnos mot PHN eller cancersmärta. Den förhandlingsronden kan bli guld värd. :-)"

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    • I hope this is a little better than the Google translation. Sorry, but bedtime for the children...

      ""EpiCept's CEO has just emphasized something sensational during their webcast.

      The results of NP-1 trials of neuropathic pain in cancer and cancer treatment was sensationally strong values: The FDA requires a security range of 1:20 that there is no chance that control the outcome ("p-value of 0.05), NP-1 -cream showed a statistical certainty about 1:1000 that chance caused the outcome (p-value of 0.001). This is mentioned and known.

      What is not commented on is the facts from the trial that CEO Talley presented on the webcast: cream gives more performance for each additional week of treatment extension after 4 weeks. This was a s i g n i f i c a n t observation. (Phase IIb trial, patients treated for 6 weeks.)

      Here is the important statement to be done:

      EpiCept have two years ago conducted a phase II trial in the diagnosis of neuropathic pain. The study had a 4-week treatment with a p-value of 0.07, not 0.05 as was necessary for the FDA. The company hinted that it would probably be better results if the treatment was extended for each patient. The patient group is enormous and includes, among others diabetes pain. The diagnosis of turnover is about 5 billion USD a year only in the United States.

      The important result of this new study in cancer pain is that it shows that a phase III study of the comprehensive nature of the diagnosis of neuropathic pain will be successful by a wide margin, if the treatment is extended to 6 weeks.

      Additionally, now with significance that there were no side-effects of the cream other than the placebo gel returned.

      That a Phase III study with very high statistical accuracy can be home for the entire diagnosis neoropatisk pain is sensational. These new data do I give a deal the market has totally underestimated.

      The question is whether NP-1, based on these new data, have, as it stands now, far greater value for EpiCept than its already approved cancer drug, Ceplene. Yes, perhaps even at the approvals for Ceplene in new diagnoses of other forms of blood cancer.

      NP-1's strong performance gives Epicept new opportunities. These results give new contacts with those BigPharma who wants to run the NP-1 for the broad diagnosis of neuropathic pain, not just a part against PHN, or cancer pain. That negotiating round can be worth gold.

      • 2 Replies to larshansson18
      • Nice work. But, BIG "BUT".

        You said
        "The question is whether NP-1, based on these new data, have, as it stands now, far greater value for EpiCept than its already approved cancer drug, Ceplene. Yes, perhaps even at the approvals for Ceplene in new diagnoses of other forms of blood cancer. "

        It's very nice to see you are talking about the real issue: Value"

        So, please share your thoughts what is the value of NP-1 or EpiCept?

        If I recall correctly, you did some "value" calculation about EpiCept which is one treatment equal $ and how many treatment first three months equal $$ and after one year it will increase to $$$, remember this is about one year ago and so far the $$$$ is ZERO, RIGHT?

        and PPS? after one reverse split and looks like another one is coming.

        What's wrong here? why a company with so much potential (as you suggested for years) and share prices keeps going down ( for years)?

        Thanks for sharing your thoughts

      • i apprecaite your well thoughout input this is why I am calling epct the next HGSI...CHEERS..Patience required but it will happen...thanks again and good luck...

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