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GenVec, Inc. Message Board

  • redspinelpinktopaz redspinelpinktopaz Apr 1, 2014 4:35 PM Flag

    Dosing

    Are we getting close?

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    • GNVC is not going to do the trial, it is Novartis's job. They have the FDA go ahead and should start it soon. There will be between 26 and 46 patients dosed in the trial and there will be a dose escalation. Even the lowest dose, which is to test safety and is about 1/5 the strength of the dose they plan, may accomplish some hearing improvement. If the first few patients are okay, they intend to increase the doses, so there should be a growing potential for efficacy. I don't know how long they expect it to take to determine if the drug is having an effect on hearing, but I would imagine it is only a month or two. The gene therapy has to take hold and then the treated cells must connect the sound to the brain so it can register.

      • 2 Replies to end2war
      • I think you need to allow more time. In other drug trials I've followed several weeks were required between dose escalations, and the escalation were small. Of course if efficacy's seen at very low doses we could all be very pleasantly surprised. Novartis will determine how much to say, or not to, and if they're like most giant Pharmas, they won't say much until they feel certain of success. Tiny Biotech's often do the opposite, and GNVC could certainly be in that class, but they're not in charge and even if they know what's happening, they can only say what Novartis permits them to.

        Gary

      • "...the treated cells must connect the sound to the brain..."

        I believe the 'treated cells' grow hairs which vibrate and the vibration is picked up by
        the auditory nerve. Correct me if i am wrong.

 
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