Hough Ear Institute's Hair Cell Regeneration Project

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

  1. Watch Hazel share good news about tinnitus
    1. DimLeb

      DimLeb Member

      Tinnitus Since:
      14/03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy Or Maybe Loud Music
      This seems very suspicious given there are no official announcements from the involved companies and even the FDA site...
       
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    2. Sentinel
      No Mood

      Sentinel Member

      Tinnitus Since:
      Late November/Early December 2020
      Cause of Tinnitus:
      Really epic hobbies
      Yeah about that.

      So I called them at their public number, they were super nice and transferred me to the correct people. The lady who works at Hough Ear Institute told me that they are still in clinical trials and are currently undergoing a two-year study that will complete in September of 2022, at which point they have lined up a financier to fund them through Phase II-III (?) clinical trials. At that point, they said they have to define/decide whether or not the drug is going to be for tinnitus or hearing loss.

      They said nothing about a compassionate use program, but who knows, that doesn't mean one hasn't been approved elsewhere. I guess we will see. I may be wrong and the person I talked to might only have access to a certain amount of information. She knew about this forum and was very eager to talk though.
       
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    3. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      They said they are doing a two year study before they start Phase 2? This company is ridiculous. Man I remember when I first got tinnitus, this was one of the only companies creating a drug, and now it’s going to be the last, literally. This company is one of the slowest companies I have ever heard of. If they did Phase 1 in 2014, how much longer do they need lol.

      Gonna make us wait 15 years for this drug to come out. Seems like they're still not sure it actually works. Idk, I wish they had more data on it, not just mice testing. They need to speed things up.
       
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    4. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Hi everyone,

      @Markku asked me to jump on real quick and give everyone an update on the news article from koreamed.com.

      I read through some of the comments and questions here. I will do my best today to answer them individually - but there are some "repeats" so be sure to check out all the responses. If I forget something - let me know. However, please note that my last day with Hough Ear Institute is officially December 3rd, while my last full day in the office is tomorrow.

      To the article: HEI's CEO Dr. Rick Kopke was unaware of this article until I shared it with him. We did work with Dr. Kesari who wanted to seek approval for expanded use. The last Dr. Kopke was aware of was Dr. Keasri and Oblato seeking and receiving approval. However, Obalto did not have any of the drugs to offer the patient.

      It appears from the article that may have changed, but we are unaware of it.

      A colleague will monitor this thread after I leave and give updates as she is able. Please be nice to her :)

      Justin DeMoss, M.A., CFRE
       
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    5. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Expanded Use is typically done on a case-by-case basis. Reading the article, it talks about "a chronic tinnitus patient." NOT patients, plural. To be clear ;)
       
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    6. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      We don't know yet. The questions you are asking are generally found when dosing is determined, which is Phase II and III clinical trials.

      Our estimation is that it would be a one-course treatment. That might be one pill or a month of pills. Our research suggests that once the nerve endings or regenerated into meaningful connections - they do not deteriorate. More research is needed to answer the question definitively.
       
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    7. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      We have data on the pill's efficacy in pre-clinical trials for SNHL, ototoxicity, and tinnitus. We believe it might also be helpful with hyperacusis and Meniere's disease.

      The pill helps absorb toxins/reduce inflammation and regenerate meaningful nerve connections between the cochlea and the auditory nerve.

      Phase I clinical trials were completed in 2015. Too long ago! In February 2020 Oblato licensed the drug from OPI (commercialization partner) of HEI. We are all waiting on Oblato to determine which clinical indication they are going to pursue phase II clinical trials for. Phase II clinical trials typically take 1-2 years and cost $5-10M. Phase III clinical trials take 2-3 years and cost $50-100M.
       
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    8. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Incorrect, the article says patient, singular. Not plural. We also are unsure how accurate this article is and are inquiring. Sometimes we are the last to know ;)
       
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    9. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Or blast-induced. There are probably several "causes" of tinnitus. We are going after the most prevalent one, at least what is thought to be the most prevalent cause.
       
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    10. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Yes, the cause of one condition can be the cause of a second condition. So, the mechanism of how the drug works can have multiple uses. Also, the drug works in multiple ways.

      We have data that indicates it works for SNHL, ototoxicity, and tinnitus. We believe it may be helpful for hyperacusis and Meniere's disease.
       
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    11. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      The real term is expanded use.

      Read more here:
      https://www.fda.gov/news-events/public-health-focus/expanded-access
      Read more here:

      https://www.fda.gov/news-events/public-health-focus/expanded-access
       
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    12. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      Hi! I was in the room training the lady you spoke to. Let me clear up a few things that got misunderstood.

      • NHPN-1010 is in a proof-of-concept study (2 years) before tinnitus will be considered for a Phase II study for the clinical indication of tinnitus. That doesn't mean Oblato can't move forward with another indication in the meantime.
      • I wouldn't say we lined up a financier. Our business model is to do initial, pre-clinical, and maybe some clinical research to attract for-profit biotech firms to take our research through any remaining clinical trials. Oblato is a biotech firm, not a financier/venture capital group. We are a non-profit so we can't pay dividends on donations ;)
      • She did say a decision would have to be made, but that can be done at any time. I doubt they will make a decision before this 2-year proof-of-concept study is finished because they do not have all the data.
        • I'll post more on the proof-of-concept study with our current milestones.
      Thank you for the kind words about my collegaue! We hope to bring you relief.
       
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    13. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      @Justin De Moss, so can you confirm that Dr. Kesari was working with the drug? The article does state that he saw efficacy with the drug having a therapeutic effect on tinnitus.
       
      • Good Question Good Question x 1
    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
      To speed things up takes money. We are a non-profit that relies on government funding and private donations. The two-year proof-of-concept study has several objectives. I will post what milestones we have accomplished in another post.

      To help you better understand what is happening, imagine you run a biotech firm, and 1 out of 10 trials you furnish will fail. Now, HEI comes to you with a drug that has data to support it with SNHL, ototoxicity, and tinnitus. As a biotech firm and part of the FDA approval process, you have to pick one clinical indication to fund for each trial. You can run three trials at $10M a piece or you can collect all the pre-clinical data you can and make an informed decision, reduce your risk of loss, and intentionally choose the indication that is most likely to get FDA approved.

      The POC study was requested to see if it worked on chronic tinnitus, to have a larger study done to see if it still works, and other factors - before the Biotech firm decides where to invest $10M; in the clinical indication of tinnitus or some other indication.

      You can see that they can move forward right now with any indication they want. They are choosing to play it safe. Also, FYI, the POC study costs $735,000. $300K was supplied thanks to the state of Oklahoma through an OCAST grant, and $300K from the biotech firm.

      If you ask me - that says all anyone really needs to know about the science and HEI. We are real researchers, doing real research, for real solutions. If you think non-profits can just get grant money from the government without good science - you are mistaken.
       
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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
      Keep in mind this was an article written by a reporter. They don't always get the facts straight. Before we got connected to Dr. Kesari were already working on funding this POC study because we already had pre-clinical data that indicated the pill's efficacy on tinnitus. Dr. Kesari was introduced to me back in June 2020 give or take. I introduced him to Dr. Kopke. They talked and that was the last I heard of it until now.

      The article makes it think that Dr. Kesari suggested that this would work for tinnitus and I'm sure the reporter just misunderstood their source. We have known about its potential efficacy with tinnitus for much longer than Dr. Kesari has been involved with HEI, OPI, Auditus, and Oblato.

      Until I hear back from Dr. Kopke - I can't confirm that Dr. Kesari is working with the drug.
       
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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
      This is a report from our COO of HEI and our research team on the milestones this year with our proof-of-concept study:
      • We were able to develop a unique model of noise-induced neurodegeneration that does not result in permanent hearing loss but does evoke a chronic tinnitus percept.
      • This is allowing us to study the impact of nerve ending loss on this auditory disorder without the confounding element of sensory hair cell loss or clinical-grade threshold shifts.
      • We also discovered that the nerve ending loss induced by this noise exposure is rapid and occurs within the first 24h after an insult of this type.
      • The ensuing nerve ending loss is permanent without treatment.
      • These findings have marked implications for recreational and occupational noise exposures that induce subclinical degrees of cochlear nerve damage and which may account for permanent loss of hearing acuity (speech-in-noise, i.e. trouble hearing in a crowded room) and the inception of auditory disorders, such as tinnitus, when normal hearing function is seemingly preserved.
      • We are now performing a series of testing regimens to determine if our therapeutic technology can prevent or reverse this type of auditory nerve damage.
       
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    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
      A huge thank you to everyone on here. I hope you all will still consider supporting HEI's research efforts. Right now, any new donor has their gift matched 100% by the JASCO Giving Hope Foundation here in OKC. Anyone who has given in the last two years can have their gift matched if they give more than $2,500.

      Please keep in mind HEI does more than just try to solve the issue for tinnitus but many other clinical indications as well. Donors can choose where to have their funds directed, like tinnitus, SNHL, etc.

      Thank you all again, and I hope and pray that all of us will get the relief we seek.
       
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    18. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      Well thanks for your reply Justin. I appreciate it. Nothing against you personally. I know things take a long time and Hough is playing it safe. Thanks for the informed answer.

      “OPI develops novel therapeutics for hearing loss. OPI's lead product, an oral fixed-dose combination of HPN-07 and NAC for treatment of acute sensorineural hearing loss, is scheduled to enter Phase 2 clinical trials in 2016 in Noise-Induced Hearing Loss (NIHL) and tinnitus. Extensive preclinical research, done collaboratively through Oklahoma Medical Research Foundation (OMRF) and HEI and supported by nearly $5.4 million from the Department of Defense, has demonstrated the potential effectiveness of an oral, fixed-dose combination of HPN-07 plus n-acetylcysteine (NAC) to treat NIHL by reducing acute damage and promoting healing and recovery of the injured cochlea.”

      This article was in 2016. I know you said you guys chose to play it safe but what has been going on for 5 years? Wouldn’t the two years of testing you guys are doing till 2022 to make an informed decision happened by now. It’s all just lack of funding?
       
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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
      My pleasure. At HEI we try to be different than everyone else. I've tried to make it more personal by responding to emails, texts, forums, etc. I tried not to use canned or stock answers/emails. I tried to post on here as much as I could.

      I have had a lot of joy these last 3+ years and will miss the mission and raising money for something I love and believe in.
       
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    20. HootOwl

      HootOwl Member

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      10 years to get to a phase 2, god damn.

      What a joke Hough is when it comes to actualizing their products. They should have spun their research department off into its own biotech a long time ago, because holy shit, this is just embarrassing.

      and this is coming from someone who believes in the scientific potential of your compounds.
      Yep, you sure do.

      smirk-sealed-lips.gif
       
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    21. lymebite
      Vegged out

      lymebite Member Podcast Patron Benefactor

      Location:
      United States
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Unknown
      Thanks, @Justin De Moss, for all the detailed info. Appreciate you filling us all in and appreciate the continuing efforts of you and HEI.

      Sure wish I or someone had $50 million to send to speed up trials, but I’m painfully aware how difficult it is to raise funds for tinnitus research. Even the American Tinnitus Association, which has many members and a long history, typically manages to scrape together only around $1 million a year in total donations, and much of that gets spent on administrative salaries and the magazine. In a good year they devote $100k or $200k to fund research, which of course doesn’t go very far.
       
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    22. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Thanks for the answers Justin and good luck in your next career.

      You say the drug possibly helps with hyperacusis. Where can I read more about that, is there a published paper with this information?
       
    23. Fields
      Busy

      Fields Member

      Location:
      Netherlands
      Tinnitus Since:
      04/2020
      Cause of Tinnitus:
      Noise trauma
      Thanks @Justin De Moss for taking the time to answer all of these questions. Best of luck to you in your new career!
       
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    24. Brian Newman

      Brian Newman Member

      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Shooting/loud noise
      I wanted to make this post to inform everybody who does not know what’s going on. There was a heck of a lot of confusion with that post about compassionate use. Despite what Justin said I talked to somebody from Otologic Pharmaceuticals which is the biotech part of Hough Ear Institute, correct me if I’m wrong. The drug is not owned by Hough Ear Institute; they truly don’t know what’s going on. Oblato owns the drug now.

      And I believe the guy that did the compassionate use was for the treatment of glioblastoma. I believe he had tinnitus and hyperacusis while he got the treatment.

      “OKN-007 is a free radical scavenger that eliminates reactive oxygen species and reduces necrosis, hypoxia, inflammation, and angiogenesis, thus normalizing the tumor microenvironment that drives glioblastoma growth.

      Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato also plans to conduct a clinical trial for DIPG with OKN-007 in combination with standard of care radiotherapy.”​

      I haven’t been able to get in touch with them. No responses to my email. If anybody wants to call them and ask what’s going on and when is the Phase 2 starting for hearing loss and tinnitus that would be perfect. I have catastrophic noxacusis so can’t make phone calls.

      It also is good news because we all know that when anything has to do with cancer or brain issues it is way more important than hearing issues in the medical world. They are calling the drug OKN-007 now.

      2021 February
      • Granted Fast Track Designation for OKN-007 to treat Diffuse Intrinsic Pontine Glioma from the FDA
      That was also on their website. This drug will actually get approved faster than we think, since Hough Ear Institute is incompetent with managing this drug. It will most likely be the same situation as SPI-1005 (Ebselen) to where it was tested in the past for hearing problems in pre-clinical trials, but gets approved for something else. Once it’s approved in the use, it will be much easier to obtain.
       
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    25. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      That’s exactly how I read the article too. And they did confirm the doctor was seeking to use it for compassionate use.
       
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    26. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      30/12/13
      Is the Hough Ear Institute's pill meant to help chronic tinnitus? Does anyone know this?
       
    27. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      I think we found the holy grail of medicine here.
       
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    28. DimLeb

      DimLeb Member

      Tinnitus Since:
      14/03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy Or Maybe Loud Music
      So we still don't know if that drug, whatever they call it, is effective for tinnitus...
       
    29. xyz
      Alienated

      xyz Member

      Location:
      Germany
      Tinnitus Since:
      2006 mild T 2019 T worsening H onset
      Cause of Tinnitus:
      unknown / probably noise induced
      This has now totally confused me. They are now trialling the HEI bomb blast pill for cancer treatment, seriously? If this won't work, they will probably trial it for MS and in 2030 maybe there is a Phase II trial for tinnitus.
       
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    30. Kam75

      Kam75 Member

      Location:
      FRANCE
      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Noise induced trauma in 2014 and 2019+ototoxic drug in 2020
      My understanding is that they have passed Phase I and are in Phase II, which must mean that their drug works.

      However, with the luck we have, it is very likely that they will fail Phase II and we will be left hoping for another drug to work...
       
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