Hough Ear Institute's Hair Cell Regeneration Project

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

    1. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I guess Tinnitus Talk members giving something like 5 bucks each would help hugely haha.

      However, I wonder whether there is another actual reason they want this money.

      My view is that there would be several charity organisations who would willingly donate for this thing and the other treatment for the big benefit it may provide.

      Furthermore, from the fact that they tell us their pill is effective, getting it moving forward shouldn't be too hard, although I still sort of wonder why they don't give explain in greater detail why they need the funding and why they were not able to obtain it from other sources like the pharmaceutical partner company.

      could it be that they had sigbed an agreement whereby they then had to prove its effects first or is it something else.

      i really+would want to know this too the thing that we do know is it is likely companies like fx will proceed pretty much further more quickly because of their willingness to move on it. it is also the fact they are actually willing to fund finding things privately which will correctly assist and gain more interest.
       
    2. Balmy

      Balmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Not 100% sure. Probably acoustic trauma.
      I thought phase 1 was completed in 2015 and the hurdle forward was funding?
       
    3. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Some actual updates from Hough Ear Institute via Facebook:

      Injection information:
      No, the injection has NOT been picked up by a pharma group. We are currently looking for investors and or donations to do the phase I clinical study. That often helps attract a pharma company by demonstrating less investment risk on their behalf.
      re: the proof of concept study for tinnitus - they have agreed to pay for nearly half as a match to the OCAST funding. So we only have $135K of the $735K left to raise!

      Pill:
      It can seem never-ending, but research does take time. Primarily because funding and partnerships take time.
      The pill is funded for Cochlear Implant Trauma, hearing loss, and ototoxicity - depending on which indication they want to pursue.
      Once approved for any of these conditions, it can be prescribed off label (leaving you to pay the full market price) for tinnitus.
      That's why we are trying to get this tinnitus study off the ground. The pharma company is very interested in it and require a proof of concept study before entertaining a Phase II trial tinnitus.

      For the pharma company to do a Phase II, they have requested one additional study. That is the study we are trying to get funded. $300K came from OCAST and was matched by the pharma company. The total cost is $735K so we only have $135K total to raise. We also have a matching grant, up to $400K of private donations, so we really only need to raise $65K for the tinnitus study to get going! That's
      65 people with tinnitus giving $1,000 each or
      130 people with tinnitus giving $500 each or
      260 people with tinnitus giving $250 each or
      520 people with tinnitus giving $125 each.
      With 20 million people suffering from it - that shouldn't be hard!
      But it is because we aren't connected to all of them and most people I have talked with are quick to spend $300-$500 on an essential oil or some other non-scientific "hope" but when it comes to supporting real science - they have all the excuses in the world why they shouldn't support real science. That's the challenge we have in hearing loss research - It's not the same in cancer research or heart disease.
      We have given people the opportunity to set up and raise money for this - but only a 5 have signed up across the entire world. Check it out and consider joining us to end tinnitus.​


      The question that is still outstanding is whether the pill treatment would work for all three indications it is supposedly designed for, i.e. ototoxicity, hearing loss, and cochlear implant trauma, or if it is going to be indicated for only one of the aforementioned.

      OR

      Does it mean that they are actually only examining one of these indications (e.g., ototoxicity) to pass the trial thresholds and requirements. Hence, providing the trial is successful, we can obtain the pill treatment for any of the three indications they have stated it is going to treat (ototoxicity, hearing loss, and cochlear implant trauma).

      Thus I have hit them up with a follow-up question of what the pill treatment's indication will be.
       
    4. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      The Oblato trial is for Cochlear Implant Trauma. I think they were using ototoxicity as an example of off label use.
       
    5. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      This need of $65k from the community is so weird to me. Yes, the community could benefit from it if it went to market as a treatment, but having the consumer pay for the trial is just the weirdest thing, as they don't get monetary benefit out of it.

      Further, many people don't have money to just throw around nowadays.
       
      • Agree Agree x 1
    6. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      I don’t get why Oblato are being stingy as fuck and not contribute $65,000 for the tinnitus trial for the pill.

      If they do believe that the pill works, why not put down the $65,000. Surely they will get their investment back once they release it in the market if it ends up being successful.
       
      • Agree Agree x 2
    7. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      Also, who is spending $300-500 on essential oils?

      This is an attempt to shame those that don't just donate.
       
    8. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      The only thing I can think is that they want to see the demand for the product? But there's already a demand with the military, so asking for a demand out of the general public is... well strange.
       
      • Agree Agree x 1
    9. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      It makes zero damn sense.

      Tinnitus is a huge market up for grabs. If they had even a tiny bit of faith in the pill's efficacy for tinnitus, they would have paid the $65,000 up ages ago.

      I honestly do not think Oblato believes the pill works for tinnitus. Any other scenario does not make sense.
       
      • Agree Agree x 1
    10. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Thanks. Has testing for the pill's efficacy on cochlear implant trauma then been confirmed for the phase 2 trial? Because it didn't sound as completely clear as what you have just informed me of. If it is being tested for that in the phase 2 trial, and in reality we can get it for tinnitus and hearing loss as well, then I will be happy with that.
       
    11. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      Definitely military since Hough Ear Institute got funding from DoD, and didn’t they test the drug in Phase 1 which showed that the drug works? Do we know if any of those Phase 1 patients had either hearing loss or tinnitus or both of these conditions?

      Surely if they knew any of those patients had an improvement in their tinnitus then Oblato should put down the $65,000.
       
    12. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Justin announced that in this thread if you go back far enough. It is apparently the easiest and quickest way to get it approved.
       
    13. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      @Lucifer, read post #922:
      Either way, if their animal studies show efficacy, it is promising for human trials for phase 2.
       
    14. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      This is what I also want to know. Maybe it was a case of Hough saying that they would fund that part of it, or maybe Oblato was not going to offer to fund it more no matter what.
       
    15. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Further update on the pill from Hough Ear Institute via Facebook:

      We believe it will work for all three. No, you don't have to be in one of those categories to obtain it. That's what I mean by off label.
      Follow me here: Let's assume that it is 2026 and the pill is approved for ototoxicity. But you remember our claims that it helped with Tinnitus. So, you talk to your Dr. and he/she agrees with you and is willing to give you a prescription for the drug, even though you don't suffer from ototoxicity. What that means is that your insurance will most likely not cover the drug, but you can still get it if you are willing to pay the price.

      Now, stay with me here. If we can get additional phase II and II trials for the indication of tinnitus - then you could get a prescription for the drug for tinnitus and insurance will cover it according to your prescription plan. It might still be pricey, but hopefully not as pricey as paying full price for the drug.
      Now, $735,000 for a proof of concept study, divided by the # of people who suffer from tinnitus (20M) = 4 pennies per person. I think it's worth every penny if we can take something that could cost thousands per person and spend only 4 pennies per person and get the drug covered by insurance.​
       
      • Informative Informative x 1
    16. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Maybe I am putting the cart before the horse, however I really question the lack of information available about the effectiveness of the pill.

      Maybe @Lucifer's position that Oblato doesn't fully believe it will work when taken for tinnitus is true.

      Still $65,000 is such a small amount that I hope that they can get it in order to promptly proceed with the study.

      In summary, Hough Ear Institute needs to tell us why the study needs to be done to satisfy Oblato, tell us why Oblato cannot fund it in the short term (because they could profit from it hugely if it's successful), and tell us what Hough Ear Institute are doing to hopefully obtain the funding required.

      I feel that it would be fantastic to see Tinnitus Talk members to help with the funding, but I can see why people would be hesitant with the missing information.
      Thanks for that!
       
      • Good Question Good Question x 1
    17. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      It might work out if Hough Ear Institute agreed to offer the treatment to donors at a discounted rate upon market release. I definitely would donate $100 if it meant that I got $500 off the cost of the pill.
       
      • Agree Agree x 2
    18. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      At this point, I would say even a smaller phase 2 study going over effectiveness would help their cause.

      Their reasoning for donations from the public doesn't add up in my book.

      Oblato has already given them $300k for the trial as far as I know, this extra amount of $65k wouldn't be much more.

      Also, that 20M people that suffer from tinnitus? Most of those have a low sine wave in the background. They're not going to donate, nor are they looking up tinnitus.

      It would be one thing if they had data on human subjects showing improvement, but with just animal models and making such bold claims, it feels sketchy.
       
    19. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Often there is correlating data between rats or mice and humans. I have happened to see a lot of these connections, so I would not simply rule out that there is not a link at all just because there is no information on humans yet.

      While it is only $65k required right now to supposedly proceed with the proof of concept study, it is really $135k when considering the fact that the donations get matched by a third party organisation.

      What I've understood about a proof of concept study in the phase 2 trial is that this means that they need to show that the treatment achieves its intended outcomes obviously not just in its intended area of research but also actually in associated areas to be indicated for the wider benefit it may provide.

      Below is from: Proof of Principle Studies - PubMed
      Thus taking this summary of what a proof of concept study is, it seems that it is not really that unnecessary or far-fetched that this needs now to get done.

      What we don't understand is why Hough Ear Institute hasn't got the means money wise to fund this either through obtaining a loan or acquiring complete funding through their own sources.

      Simply put, it would be best if Hough Ear Institute could just come out and give solid statements, for example that they cannot fund it internally due to not having the funds available.

      Or that if they got a loan or further funding from another party like the pharma organisation then they would need to give up or lose rights to be able to sell this in the United States as a commercial treatment. Given this, they would then lose the revenue source that they would need in order to fund their other treatments such as the injections.

      This would clear things up significantly for patients and as a result really would work in their favour as it would alleviate most patients' confusion, hesitance and reservedness in donating diligently.
       
      • Agree Agree x 1
    20. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I haven’t heard much more on this in the last week or so however I am actually more and more questioning their process.

      Hough provides positive info when they released the FDA video, however since then there has been little detail provided to inform us of important pieces of information.

      This includes details on the pill’s need to be taken through the Proof of Concept study and also why they cannot obtain funding for it through the pharmaceutical company, Oblato.

      I genuinely believe that their methodology and products may be sound, however the vagueness in answering relevant and specific questions leaves me confused.

      It just seems somewhat interesting that they have not moved on with the treatment process promptly. Especially when we consider that other firms with similar treatments have done so.

      Hough are doing themselves a slight disservice by not directly indicating why there are certain delays with the process. Not to mention going by the evidence a lot of people here are also simply annoyed with their responses around the required funding such as that people are spending several hundreds dollars on potions rather than donating to real science.
       
    21. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      Hough's stance on their efforts were quite confusing initially. They are advertising much efforts in the Hough Pill but then are repeatedly talking about cochlear regeneration. However, these two concepts are completely separate target treatment. The Hough Pill is an anti-oxidant cocktail, which is primarily targeting preventative measure of hearing damage. The other one has a focus on cochlear hair cell regeneration via some specific gene therapy delivery method.

      It is very confusing how they are emphasizing their pill concoction and then talking about their excitement with their cochlear regeneration study without a very demarcated distinction because they are not the same treatment. Their communication does not inspire confidence.

      And let's be honest, we've all tried various anti-oxidant supplements, including the infamous NAC molecule that's already known to have positive preventative effects on hearing damage. I just can't seem to get excited on another NAC concoction with another molecule, especially since their studies have indicated it's primarily on prevention... And our hope that it will help chronic sufferers is just that: patient bias and hope. If it would help chronic sufferers, then I think they would have already done animal studies on chronic cochlear damage.

      Did anyone listen to the Tinnitus Talk Podcast, the Hough Ear Institute episode? Is it just me or did the explanation on how the pill works seem very mumbled and incoherent?
       
    22. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      To be fair to Hough, even if they haven't been as transparent about their financial arrangement with their partner(s), it doesn't mean their drug doesn't work.

      HPN-07 was an antioxidant/potent free radical trapping agent that they happen to discover regrow synapses in their pre-clinical studies. It seems to be a unique drug in that regard.

      Though, it seems logical to say "why would this antioxidant work when others don't?" Since presumably they have a similar mechanism of action but in medicine it doesn't always work that way. Unexpected off target effects (and side effects too) happen all the time.

      For instance, they (researchers, not Hough) happened to recently discover synapse regrowth with Bisphosphonates (an osteoporosis drug which inhibit osteoclasts), something that should not have an effect on cochlear synapses.

      Hough might not even know why it works (but maybe they do) even as they observed synapse regrowth as a pleasant surprise pre-clinically (Justin has described it exactly as a pleasant surprise). Hence, the vague scientific explanation.

      Financial transparency would inspire more confidence in their drugs but maybe they don't feel that they can disclose that sort of info for whatever reason.
       
      • Like Like x 1
    23. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I think that Hough just needs to state that they cannot disclose this information. To date all that they have said when they have been pressed on it are things like that’s just a part of research or that’s how these things work. Both comments are vague and do not do much in the way of alleviating the concern and confusion many have.

      Just come out and say that you cannot disclose the funding agreement and that way you will put all the concerns to bed.
       
      • Agree Agree x 2
    24. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Interesting update regarding the pill.

      Question:
      Answer:
      There was a follow up question asked which was:
      The above has not been answered at present.

      I would be interested in seeing whether Hough Ear Institute can provide a clearer indication on the time frame and process regarding the pill study and trial(s).

      The question of why the study needs to be completed first is still not answered. Furthermore, my understanding is that if a treatment is approved by the FDA for one indication (such as damage caused by ototoxic drugs), then there is no limitations in prescribing it off-label for other indications such as tinnitus.
       
      • Informative Informative x 1
    25. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      The link below explains that proof of concept vs traditional clinical trials pathway. I found it quite interesting and answers some of the questions you posed. Quite an interesting read.

      https://www.lifescienceleader.com/doc/benefiting-from-accelerated-proof-of-concept-programs-0001

      Tldr; The proof of concept combines phase 1 and 2 for both safety and efficacy to see if it will be a waste of time or not.
       
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    26. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      That’s the type of answer Hough hopefully will give/should have given if accurate from their end. However this should have been done at a much earlier time.

      This essentially explains what I thought about the reason for doing both together. It still does not, however, explain the reasons regarding why it will take so long to complete the trials.

      I think that the pill trial is actually up to phase 2, although not sure if it is a requirement to retest for safety with the tinnitus aspect.
       
      • Agree Agree x 1
    27. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Further update from Hough Ear Institute:
      This answer still simply makes so little sense.

      On the one hand, we are told that the drug is ready to get trialled and furthermore that there are seemingly no delays impacting the process.

      Then on the other hand, we are told that we need to get this study funded so we can continue moving forward with it.

      Something simply doesn't add up here, especially after we were previously informed that Oblato wanted the pill tested for tinnitus prior to the commencement of phase 2. I am also certain that the tinnitus study is not required as a part of FDA requirements either.

      Thus I am now keen to ask why funding through Hough Ear Institute is needed to conduct this study if it is now firstly not a FDA trials requirement and secondly being apparently run by Oblato.
       
      • Agree Agree x 1
    28. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      After reading Hough's paper on HPN-07 a second time (in regards to the Hough Pill), I can not agree that it is regenerative and thus not significant for us chronic sufferers.

      "Surprisingly, the observation that HPN-07 treatment initiated within four hours after noise exposure and continued for 2 days has long-lasting effects, some of which only become evident 21–180 days later, is not readily explained from our evaluations but could be interpreted to suggest that HPN-07 may have the capacity to initiate repair mechanisms or a regenerative response among one or more components of the cellular architecture of the cochlea."​

      After reading their data, I can not see how they are suggesting it is regenerative.

      Figure 8 (page 16-17) shows data on day 3, 10, 21, 180d of 6 animals each and all of which shows significantly less hair cell loss but more importantly the percentage hair cell loss was relatively the same on ALL days from day 3 group to day 180 group. This indicates that hair cell loss was already prevented early on by using the treatment 4 hours after acoustic shock to the animals. However, to conclude hair cell regeneration, the graphs would need to show a higher percentage hair cell loss early on and a lower percentage of hair cell loss at a later date. The fact that percentage of hair cell loss did not change much for all days of 3, 10, 21, 180 do not reflect hair cell regeneration but rather hair cell lost prevention early on.

      However, their research does show it is an effective preventative measure and that is great.
       
    29. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Their pill (HPN-07) reportedly regenerates synapses, not hair cells.

      Their pre-clinical intratympanic injection drug (totally different drug) addresses hair cells.
       
    30. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Further follow up from Hough Ear Institute - Much clearer now:
      This is a lot more clearer compared to the previously provided details.

      So it seems significant to know that the FDA approved clinical trials for hearing loss as an indication and the other study for tinnitus as an indication are totally independent from one another and although Hough Ear Institute wants to get the tinnitus study done ASAP, the FDA approved clinical trial for hearing loss will commence this year.

      Therefore, there is a possibility that the treatment could be available before the tinnitus part of the study is completed.

      Clearly we can only hope that the hearing loss trial is successful so we can have actual access to the treatment off-label within a couple of years rather than potentially six years or so for the tinnitus study to complete.
       
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