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Incyte Corporation Message Board

  • jacosa jacosa Dec 6, 2013 12:06 PM Flag

    Immunization against expected Geron outbreak

    They'll be presenting a study on Imetelstat on Monday, and if history is a guide we'll be flooded with triumphalist postings. They will be garbage, for several reasons.

    First, and most important, is that the drug can't reach market by a time that means anything to INCY investors. The study being reported shows efficacy and gestures at determining dose, but it is not a proper dose-determining study. A proper phase 2 to set dosing will take most of a year. Following that, two registration studies (phase 3s) will be required to obtain licensing in the US. Call it another 2 years. After that, there is an unknown delay for FDA to act--typically most of a year. So marketing is 4 years off if everything goes right.

    Less important at this stage is that Imetelstat combines several features that have been bad news for drug candidates in the past. It is a lipid-conjugated polynucleotide targeting telomerase. Lipid conjugation tends to produce immune responses, polynucleotide (I switch from 'oligo' to 'poly' at 8 nucleotides, but nemmine) drugs tend to be very toxic, and targeting of telomerase has caused a lot of problems. Not to say that it can't be a good drug, just that FDA is going to be especially cautious.

    Less important yet is that the text describing the results is written by A. Tefferi, who has lied repeatedly in public about myelofibrosis treatments. The preliminary release referred to partial and full responses on the basis of histology, with no evidence given on symptomatic improvement nor acknowledgement that it is part of the definition. Deaths occurred that were judged not to be treatment-related. Tefferi is a superlative clinician, but whenever he has touched a study, other people need to interpret the results.

    Least important of all right now is durability of response. Myelofibrosis is a chronic disease, so a durable response is important. Even if a 6-month study shows 'full responses', it doesn't speak at all to durability.

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    • Comical...

    • Jacosa, a) I agree with you - by and large - and I too have the same opinions as you re Tefferi. B) nevertheless, IMO it is important to keep an open mind. I believe targeting telomeres is laden with complications and unwelcome toxicity surprises. Frankly, I don't think telomeres are well understood. So, one never knows what nasty surprises and blowbacks await. Despite all that, I am still keeping an open mind. Let's see all the data and side effects from Tefferi, the evil one! LOL

      • 1 Reply to nickiperu
      • I made Tefferi the third problem. Everyone can look at his data; he hasn't been caught falsifying data. But we are obliged to ignore his interpretations and let others do the interpreting, because he emphatically has been caught falsifying interpretations.

        I'll stick with my first point first: at best, Imetelstat can't get to market in under 3 years; with FDA suspicion, 6 years is a better guess.

 
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