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Vertex Pharmaceuticals Incorporated Message Board

  • gladpick gladpick Jul 21, 2012 9:01 PM Flag

    What happened to the Alios 7 day study?

     

    This was stated in the 1st quarter report:

    "Viral Kinetic Studies of Two Alios Nucleotides: Seven-day viral kinetic studies of the nucleotide analogues ALS-2200 and ALS-2158 are ongoing in people with hepatitis C. The first data from these studies are expected in the second quarter of 2012. If successful, Vertex plans to begin Phase 2 studies in the second half of 2012 to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK or VX-222 with or without ribavirin, as well as other potential interferon-free combination regimens."

    Since it says the data "are expected in the second half of 2012" I do not understand why they have not released the data yet. I wonder if the data was bad and in the second quarter report they casually may announce that they won't follow thru with the Alios compounds. I am sure most remember that Jeff already has said if the results are not very good he will abondone it.

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    • Thanks third. I will. I will be around for about 2 1/2 months before the surgery. The doctor says I first have to heal up the small hole in my colon pouch before they can do surgery. Meanwhile I am on somwhat of restrictive diet.

      My advice to anyone who is middle age is to have a colonoscopy every 5 year and if one discovers any pouches (pockets)in the colon to be very careful with one's diet.

    • Glad, the latest states that the trial is 31 day evaluation (look up the link below). The primary end point is safety. This is the most important indicator now for moving forward with development of these compounds. Alios already knows that once-a-day dosing is possible, both are efficacious as any DAA, and have a very high barrier for resistance, all from preclinical studies. If, this is big if, both are as safe as PSI-7977, then the VRTX market cap should increase by 10B minimum.

      Let me explain why this is the case. Remember PSI-7977 was a pyrimidine and PSI-938 was a purine. Als2200 is also pyrimidine and Als2158 is purine. They are all prodrugs which have to be converted into active forms in the liver cells. The activation involves attaching phosphate to the prodrugs. If a prodrug is given twice as much, the activation process would be slower because the drug molecules have to compete for the same cellular phosporylating enzyme. On the other hand, if both purine and pyrimidine drugs added half each, then because the enzymes are different, the activation process will not be slowed. Moreover, the sites of viral polymerase inhibition are different for pyrimidine and purine types, so that their inhibitory actions do not interfere each other. The end result is that the effects of Als2200 and Als2158 will be additive or synergistic.

      The viral kinetic study of PSI-7977 and PSI-938 given together to HCV patients did not indicate synergy btw the two, not even additivity. Furthermore, the toxicity observed in the arm receiving 938 was a crushing blow to their combo development.

      If Als2158 and Als2200 are safe and synergistic in destroying HCV, a 4-8 week treatment regimen would be a possibility.

      http://clinicaltrials.gov/ct2/show/NCT01554085?term=Alios+2158&rank=1

      • 2 Replies to thirdmeinvestor
      • Third,

        I was in hospital for 4 days and did not have access to any computer to responde to thank you for the info you provided which was invaluable--your explanation of the science involved in alios compounds as well as the 31 day study.

        Before my last post, I tried my best to read all the news releases and quarterly reports mentioning the Alios trials and the only thing I had found was the quotes in my post about the announcement of the 7 day results. Thanks for finding that link to the government trial site. At least that indicates to me that they are still working on the Alios compounds.

        Thanks for being a valuable resourse on this board.

      • Great info, tx. My only problem is back to the original point; they said they would report out in Q2 and failed to deliver. Crickets from vrtx on this. Maybe they are being extra careful after the CF fiasco.

 
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