Novartis Pauses Study of GenVec's Gene Therapy CFG166 (UPDATE May 2016: Trial Is Again Continuing)

Discussion in 'Research News' started by Anonymous2929, Jan 12, 2016.

    1. Margus

      Margus Member

      Tinnitus Since:
      01/2015
      Cause of Tinnitus:
      Unknown
      Any news on CFG-166? Estimated trial completion date was December 5th.
       
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    2. Hammers

      Hammers Member

      Tinnitus Since:
      04/19
      Cause of Tinnitus:
      Acoustic Trauma: Too close to fireworks with no protection.
      Still nothing on their website or the ClinicalTrials.gov page...
       
    3. mrbrightside614

      mrbrightside614 Member Benefactor

      Location:
      NE Ohio, USA
      Tinnitus Since:
      07/2019
      Cause of Tinnitus:
      Acoustic trauma
      Probably takes some time to officially report results, but this therapy was not at all on my radar so it’s nice to see that there’s another player in this game that (may be) close to reaching the market.
       
    4. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      Not so good news. This trail is suspended again:

      https://www.hearinglossjournal.com/novartis-suspends-cgf166-trials/

      Remember: CGF166 is delivered by a small surgical operation where the eardrum is temporarly shifted aside. Not a very attractive treatment but it is intended for people with profound hearing loss. Again little is known about the exact results achieved until now.
       
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    5. FGG
      No Mood

      FGG Member Hall of Fame

      Tinnitus Since:
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      A few of my thoughts of the problems with this:

      This procedure uses a cochleostomy to insert the medication, which causes enough inflammation to be very destructive to hair cells, sometimes widely.

      There is a newer surgical method for delivery of AAV involving a canalostomy. This procedure is completely safe for the cochlea. It would be great if they could switch over to this method.

      Very severe to profound loss means you have little to no support cells left, which means there is no substrate for the drug to act on. The ones who benefited likely had less severe audiograms.

      I am willing to bet when they restart they will cap the thresholds around 70dB-80dB losses.
       
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    6. Tezcatlipoca
      Question it

      Tezcatlipoca Member

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    7. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
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      acoustic trauma
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    8. FGG
      No Mood

      FGG Member Hall of Fame

      Tinnitus Since:
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      Multi-factorial
      I'm not sure how to read this. It does look like the 40 µg dose was most effective if I'm reading this correctly:

      Capture+_2021-05-06-13-05-23.png

      Particularly for lower frequencies, which would make sense since their surgery was really inflammatory/destructive for higher frequencies especially it seems. Also possible they were in the more severe range (vs profound) in that range and their drug transduces support cells, not fibroblasts.

      I wonder if they plan to retry and change their delivery method/surgery.
       
    9. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Couldn't they just inject their goop with an intratympanic injection?

      That delivery method seems very counterproductive.
       
    10. FGG
      No Mood

      FGG Member Hall of Fame

      Tinnitus Since:
      01/2019
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      No. Viral vectored therapies have to be directly inserted into the cochlea. That's a big problem with them. Akouous has come up with a new surgery though involving Stapes venting which is less destructive.
       
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    11. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Those procedures are going to be a Hail Mary if intratympanic injection therapies get FDA approval.
       
    12. lello

      lello Member

      Tinnitus Since:
      2018
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      unknown
      I'm trying to interpret these results, but I can't.

      Basically it recovered over 20 dB on the low frequencies and little, or even nothing, on the high frequencies?

      Has the research been completely abandoned or is it still ongoing?
       
    13. BohemianLife
      No Mood

      BohemianLife Member

      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Hearing loss
      It seems like a 20-30 dB recovery in the first 3 frequencies (low frequencies) but there is no recovery in the other frequencies.

      I think if there was a 20-30 dB recovery in all the frequencies, they would go for further steps. But what I understood is they thought these gains are not worth the risk of the surgery. I wish there was a more safe method for injecting the drug.
       
    14. Geatly

      Geatly Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Noise induced, by jackhammering into concrete on constructio
      I don't understand it really, why can't it just be injected through the eardrum, or is it different from the drugs by Otonomy or Frequency Therapeutics? I understand that back then there weren't proper delivery methods, but c'mon guys, we got them now, use them please.
       
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    15. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
      Could they go through the Eustachian tubes and enter through the window membrane? Using some time of catheter?

      1200px-Anatomy_of_the_Human_Ear.svg.png
       
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