Hough Ear Institute's Hair Cell Regeneration Project

Discussion in 'Research News' started by all to gain, Oct 2, 2019.

    1. Flyingsheep
      Sheepish

      Flyingsheep Member

      Location:
      Cleveland, OH
      Tinnitus Since:
      09/2018
      Cause of Tinnitus:
      Unknown
      New video up on the Hough Ear Institute YouTube channel about the FDA approval process.

      Hough Ear Institute - FDA Approval Process
       
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    2. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      Man, I’ve been critical of this method and speed, but that was some good, clear info on the process. I just wish I could hack YouTube and have that video play over every other to raise awareness.
       
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    3. El BUZZ
      Buzzed

      El BUZZ Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Loud music consumption plus acoustic trauma.
      When do you guus speculate "the pill" will be available for the general public?
       
    4. UKBloke

      UKBloke Member Podcast Patron Benefactor

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      Loud Music / family history
      I hadn't realised they've also come up with an inner ear injection. Interesting stuff...
       
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    5. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member Podcast Patron Benefactor

      Tinnitus Since:
      -
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      -
      Great video @Justin De Moss.
       
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    6. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      The timeline they have given is two to four years. They have told us they need to do the proof of concept research study first, and then the phase two trial.

      They have also been given the Fast Track status from FDA so they can release the drug once phase two is done provided they can show it has benefit as this is the only criteria not yet satisfied.

      The only query many on Tinnitus Talk have is why do they need to do a proof of concept study before phase two and why do they need donations from individuals to do that.

      Once these two things get answered it will alleviate many people's concerns here.

      I also don't get why they wouldn't push it forward faster from the point of view that they can financially benefit sooner from a great product if they put it out on the sales market.
       
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    7. El BUZZ
      Buzzed

      El BUZZ Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Loud music consumption plus acoustic trauma.
      Thanks mate for putting your invaluable time in answering me in such a well articulated way.

      Every time a potential treatment or cure has been on the horizon, lots of tricky questions have arosen. This forum is prone to deep speculations which is good for some perspective. Thanks again and hugs.
       
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    8. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I think the truth is that the skepticism, questioning, debating, arguing and speculating seriously significantly enhances the discussion.

      There is an absolute need to challenge things though. If you don't, then the information around an issue is not as helpful or good as it might be.

      We should be querying Hough Ear Institute on the reason why do they need to do a proof of concept study first before being able to do the phase two trial.

      We are ultimately the ones taking the treatment and funding their product.

      I'm pretty positive that we know their product works wonderfully and will get granted early release. We simply just don't have any insight into why they need to do that proof of concept study first.
       
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    9. Balmy

      Balmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Not 100% sure. Probably acoustic trauma.
      Was it ever reported anywhere that they received Fast Track status? And assuming they really did, is that a guarantee to skip phase 3?
       
    10. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Fast Track is not a guarantee to skip phase 3 at all. Regardless, I likewise do not remember hearing Hough got Fast Track status for their pill and I would like a link.
       
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    11. Balmy

      Balmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Not 100% sure. Probably acoustic trauma.
      I was able to find a comment from Justin De Moss from April 20th in this Hough thread claiming they got Fast Track status.
       
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    12. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Yeah you found it. Thanks. This makes sense why we might see this sooner rather than later. This also again makes me feel far more confident in the benefit through this treatment.
       
    13. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Any idea when they are going to start Phase 2 clinical trials? I doubt they will start this year.
       
    14. AnxiouslyWaiting
      No Mood

      AnxiouslyWaiting Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Anxiety maybe?
      I love that tinnitus is specifically mentioned in this video.
       
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    15. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      What is the Hough pill's mechanism of action?
       
    16. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
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    17. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      @FGG, thanks. It seems like the Hough Pill has a small timeframe to work, which is quite disheartening. I guess that's why this thread isn't very popular.
       
    18. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      It should work for chronic as well. Although it was designed originally as a bomb blast pill, the growth it produced in animal models should still happen in chronic cases. As for the thread not being as popular, they're not as far along as say FX-322, and there hasn't been more info. Hard to keep a thread going when there's not as much to talk about.
       
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    19. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Yep, they used a time frame a few months out to mimic chronic cases in the rodent models they used. Apparently, in those animals chronic changes happen in that time frame.

      Justin also reported that it did help tinnitus in their phase 1 human trial but what wasn't clear to me (or I just missed it) were whether these were acute or chronic human cases. Anyone know?
       
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    20. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I just posted a message on their Facebook page to ask. As of now, they are saying 2025-2026 for the pill and 2029 for the shot.

      I wonder whether their shot would still work when you've taken other things like their pill.
       
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    21. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      @FGG, as I'm almost finished listening to the Tinnitus Talk Podcast for the Hough Ear Institute, the phase 1 were tested on healthy individuals with NO hearing loss or tinnitus to measure safety. The only evidence it seems that they have is on animals where they induce hearing loss and waited for 4 weeks before using the drug, in which they saw improvement up to months. So unfortunately, their chronic hearing loss/tinnitus treatment is still in theory for humans.

      Personally, in your opinion, is 4 weeks long enough to be considered chronic in animals that translates to human?
       
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    22. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I would be interested in why they only used healthy people for their safety section of the trial.

      It seems somewhat strange that they didn't try it with people who were suffering from the problem considering that there was nothing that would have prevented them from doing this as a phase 1 and 2 study.
       
    23. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
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      Multi-factorial
      Hey, thanks. I think I misremembered based on the discussion that Justin should take the pill since he has tinnitus and had seen evidence that it helped tinnitus.

      Sorry for that. You are correct. All the evidence for tinnitus is pre-clinical in animals.

      As for your last question, I would have no way to know that. My pure guess is there are probably histologic and physiological changes that happen chronically vs acutely and they used those as markers in their animal models.
       
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    24. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
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    25. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
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    26. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      No, it's one and the same $300k OCAST grant.
       
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    27. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      So it still seems they need the $65,000 to fund the Pill. I pray that people donate or someone somehow wins the lottery and donates.

      I do think that if the Pill and the injection they have in the making are good, like they should be, they should seek out funding for it and move on with it. I know it is hard for a not-for-profit to do this, though.
       
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    28. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      Yes and that's absolutely nutters! Justin De Moss is a great chap, but as Hough's head of fundraising, he should have no trouble raising such a modest sum.

      Or is it the case of just nobody really caring about tinnitus? If it's that hard to get $65,000 together, maybe we don't deserve the cure...
       
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    29. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      @HootOwl brought up a good question. Is their US partner (Otologic Pharmaceutics) not willing to help? And if not, why not?

      They would just need to visit forums like this to see the massive potential of the tinnitus market.
       
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    30. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      https://houghear.org/grants/

      HEI got grants for phase 1 in 2013. It took them 7 years to finish phase 1 and that was with subjects who had neither hearing loss nor tinnitus. In addition, NAC and that other drug in the mixture has been shown with long term safety from a completely different treatment, as per the Tinnitus Talk Podcast. That is very slow progress just for phase 1, whereas Frequency Therapeutics took 1-2 years.

      Additionally, where is this $65,000 figure from? If the pill has that much potential, then it will also have hundreds of millions of $$$ potential in the market. $65,000 investment is a cake walk compare to that, unless there are some serious reservations by the pharmaceutical companies.
       
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