Hough Ear Institute's Hair Cell Regeneration Project

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

    1. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member

      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      Even if he has tested it on himself, I very much doubt he would tell us. Probably outside of the rules and regs.
       
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    2. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      Good afternoon,

      Since the clinical trials are funded, when can people expect the upcoming trial?

      Will there be any locations listed in the Tri state area NY, NJ, PA?
       
      • Good Question Good Question x 4
    3. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      Hello @Justin De Moss, thanks for checking in.

      The above question is very special to me. Looking forward to your response.

      Take care, and thanks again.
      Daniel
       
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    4. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      In the title of the paper on the Hough pill it states "acute acoustic trauma". However in the paper it is also stated that chronic cases have recovered. Was there done an animal test with chronic cases? Most on here at Tinnitus Talk probably belong to the chronic category, so it would be important to know if the pill should also work for the ones where the ear injury lies somewhat in the past.

      https://houghear.org/wp-content/upl...-cochlea-induced-by-acute-acoustic-trauma.pdf

      How do you came up to use the compound HPN07? Is it already used in another pill for another patient group and it was observed that it also improves hearing and tinnitus or is it something brand new? In the paper I read that HPN07 was already used in a phase III trial for stroke patients so it seems to at least be well tolerated.
       
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    5. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Did they release the stroke drug into the market? We might be able to take both HPN07 + NAC right now to restore synapses.
       
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    6. MrCrybaby

      MrCrybaby Member Benefactor

      Tinnitus Since:
      2014, 10/2019
      Cause of Tinnitus:
      School Band, Acoustic Trauma
      No, it was not released because it was ineffective.
       
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    7. xyz

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      HPN07 seems very hard to obtain. Seems like @JohnAdams already did some research into this

      However we know nothing about dosage, so probably we have to wait until phase II is over and has proven efficacy. Maybe the pill will then be opened up for compassionate use.
       
    8. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member

      Tinnitus Since:
      -
      Cause of Tinnitus:
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      @Justin De Moss
      I'm really interested to know what dosage of NAC they use in the pill. Maybe top secret though:)

      A thread was started asking whether someone could make their own Hough Pill: https://www.tinnitustalk.com/thread...0-hough-ear-institutes-bomb-blast-pill.39589/
       
    9. Chriscom

      Chriscom Member Podcast Patron Benefactor

      Location:
      Northern Virginia USA
      Tinnitus Since:
      May 2019
      Cause of Tinnitus:
      Likely infection/ear stress after walking pneumonia
      This does't have much to do with the main point here, but there's a comment about how getting down to -20C for storage requires dry ice. That doesn't appear to be so. In my search for a small home freezer, since they're hard to get a hold of right now, I started stumbling across medical-grade freezers and one of their selling points is having that capability. Did a quick search again right now for "medical freezers" and in the medical freezer biz that appears to be as common as power steering in a car.
       
    10. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I guess that was a dumb question, when is the clinical trial going to be open? Proof of concept is the reason maybe?
       
      • Good Question Good Question x 1
    11. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      I don’t think it will happen anytime soon due to COVID-19. If they started around the same time as FX-322 Phase 2a trial they could have been halfway by now.

      Still have no clue why it took them 5 years to get additional funding when they were already done with Phase 1 trials in 2015. They could have been in Phase 3 or releasing the drug out in the market by now.
       
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    12. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I see it the other way, all these companies have are excuses. If safety passed and money is already in place and there are more FDA staff working then what’s the delay? ENTs who probably get paid to host the trial aren’t working during COVID-19. I think it’s the optimal time to get paperwork through. Meanwhile the bottle sits on the shelf, or the sound stimulation machines cost $2500 and no ones cured. If you claim to have the answer, put it out.
       
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    13. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      From a recent email with Hough Ear Institute:

      "Great to hear from you! I’m sorry you are still suffering. I got sick early on during the COVID pandemic and my tinnitus, because of an antibiotic, got as bad as you and many others described. While I believe I was empathetic before, I now have first-hand knowledge and experience of how life altering it can be.

      COVID hurt us from a fundraising perspective, but we are moving forward. I just met with a donor who is considering a gift of $5,000 for our tinnitus proof of concept study. What interests him the most is that it gives us an objective way to measure the effectiveness of the treatment. Unlike Frequency’s Phase 2, which has a secondary objective in measuring tinnitus – through self-report data, we are trying to make it a primary objective to a Phase II study. What’s more, even if the pill ends up not being effective – our new objective measuring of tinnitus will allow and encourage more research for tinnitus itself!

      Oblato is still very interested in this and our OCAST grant is looking very promising.

      Be assured I’m working as hard as I can to get us a treatment!

      At your service,
      JUSTIN DE MOSS, M.A., CFRE
      Chief Philanthropy Officer"
       
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    14. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      No, I have not. I cannot because 1) it wouldn't be ethical, 2) it would jeopardize the research and the ability to get the drug delivered to help everyone.
       
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    15. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      That's the rub and it is a little more complicated. I've explained it in previous posts but here is the short-short version:
      1. Obalto has told us they hope to start trials this year.
      2. With COVID-19 - I would assume that means some delay.
      3. We have continued our research despite COVID-19.
      4. Fundraising is down for obvious reasons.
      5. We are starting to see movement on our peer to peer fundraising campaign for the tinnitus proof.
      6. Oblato will test the indications that give it the highest chance of success (Cochlear implant trauma, cytotoxicity, hearing loss, etc.
      7. The challenge with tinnitus as an indication is that there is currently no objective way to measure tinnitus, sort of!
        1. Frequency's trial has tinnitus as a secondary objective and is using self-report data.
        2. That is a very strong limitation to the study and may end up not helping get the drug approved for tinnitus or even get the drug approved in the first place.
        3. This is why having an objective method of testing for tinnitus is so important.
      8. That is why we are trying to run a proof of concept study to prove our method of objectively tested tinnitus treatments.
        1. This will be helpful for all researchers - even if our pill doesn't work, if we are successful in objectively measuring tinnitus - other drugs can be tested and put through the process very quickly with solid empirical results.
      9. Phase II studies for our pill with tinnitus will NOT happen until we can run this proof of concept study.
        1. Full disclosure - even if we do the study there is no guarantee that it will work or that the pill will work either, nor that Oblato will do a Phase II for tinnitus.
        2. However, it is unlikely if we are successful that Oblato would NOT want to run it through a tinnitus Phase II.
       
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    16. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      I mentioned it in a previous post. I'll try to find it and re-post it. If I can't I'll get back with the researchers. They know the answer like the back of their hand, whereas I do not and I don't want to mislead you.
       
    17. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Your first question: Because we have done additional studies to show that it appears to be effective in chronic cases.

      Second question: Yes, it was developed for stroke patients as well as Glioblastoma. It didn't work for stroke, but it did for Glioblastoma.
       
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    18. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      In stroke patients it was not effective.
       
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    19. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
    20. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Funding. It took 5 years to get Oblato on board with taking it through the remaining clinical trials. We had other companies interested as well but Oblato was the first to agree to reasonable terms.

      My preference would have been to fundraise for the money for Phase II and then secure even better terms with the pharma company. But that is just me and the way I do business :)
       
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    21. antonio77

      antonio77 Member

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      unknown
      Justin you have infinite patience ;)
       
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    22. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Thanks Justin for clarifying about how the process went during those 5 years. I did not realise you had other companies that were keen. I always assumed it was only Oblato that was keen to do the clinical trials.

      I am not sure if you can answer this or not but when did Oblato start the negotiating process? Was it just recently or have Hough Ear Institute and Oblato been negotiating for many years and it was only recently that you could come to an agreement?
       
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    23. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      Thank you kind sir.

      Sincerely, Daniel
       

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