Hough Ear Institute's Hair Cell Regeneration Project

[Justin De Moss]

- Are your treatments targeted also for tinnitus and hyperacusis?
- We understand that phase 1 trial is completed and was "extremely safe". While we acknowledge that Phase 1 is meant to test the safety of the medication, what were the results on hearing loss, tinnitus and hyperacusis? What is the level of improvement? Were they sustainable?
- Do you think there is potential for further improvement to the results of phase 1?
- Are you currently enrolling patients for phase 2? Would tinnitus sufferers without hearing loss qualify?
- How does your treatment work? Does it regenerate dead hair cells or does it multiply other healthy hair cells?
- In case you are aware of the treatments of other hearing loss generation companies (Frequency Therapeutics and Audio/Regain), how does your treatment differ?
- You claim that the drug might be on the market by mid 2020. Isn't it a very optimistic scenario given that you are still in the beginning of phase 2?
- Have you been able to secure capital from investors?
- How can the Tinnitus Talk community contribute to your work?

In order,

1) Tinnitus - Yes, the hearing loss pill has already shown to be effective in treating it. Hyperacusis - possibly. We haven't run a study on that yet, but that doesn't mean we won't in the future.

2) In phase I, only toxicology is/was tested. Phase II studies check for toxicology and efficacy.

3) Not sure what you mean by this question. It is already super safe for humans - so I don't know how we would/could make it safer?

4) The protocols for the Phase II study will be announced by our biotech partner and we will share that information in our newsletter and Facebook account. The best way to keep up to date on that is to sign up for our newsletter. We don't spam people, share information, rent our lists, etc. All your information stays private and with us. Yes, tinnitus and or hearing loss.

5) That's a longer discussion. The short of it is that we use existing cells, silence the RNA and become new hair cells. In completely layman's terms This is a novel approach that others have not taken and one of the reasons we have had so much success.

6) I can't really answer that specifically, to be honest. I don't know much about the other therapies since I'm a layman, not a scientist. However, I did share the Frequency Therapeutics with our CEO and he said it is different. We are going to discuss it further when he gets back from his trip to Vietnam where he is helping build a cochlear implant program of excellence in Hanoi. The takeaway message he gave me is that they are different and we are much further along than they are based on what he read. Please note, however - these conclusions are based on very limited data. They are not definitive. We'll have a better answer in the future when we can dive into their data more.

7) Phase II and III trials generally take 2 years each. That fits the time estimation well if anything it is conservative with the assumption that we will have the funding to advance the research.

8) We are a research institute, not a biotech firm. We seek innovation to get products to biotech firms to commercialize it. So, no - we don't have any investors other than people who donate to advance the research.

9) The best thing to continue to our work is to spread the word. Our research team is small as is our budget. But we have been able to do extraordinary things that much larger research outfits have not been able to. We need prayers. We need funding. We need people to be aware of the great work being done in Oklahoma City.

Thank you for asking such great questions! I'm with you. I want a solution to end people suffering.

 

[Badger19]

No funding + they just completed phase 1, so they need time to get it to market. Don't know exactly how long but let's say 5 years is reasonable.

The good thing is that in 5 years you have Frequency Therapeutics and Audio/Regain for hearing loss and possibly tinnitus, as well as Hough Ear Institute for tinnitus (they did mention their drug was "very effective for tinnitus and hearing loss". Not to forget about the three bimodal neuromodulation devices + others not that promising (Keyzilen reinvestigation + OTO-313).

So hopefully in 5 years, we can get tinnitus sorted our or at least significant reduced.

@PeteJ check out this thread - hope this gives you hope my friend.

This. We have several treatments coming up. Let's just hope hearing regeneration also cures tinnitus and hyperacusis.

 

[Justin De Moss]

Thank you. I have 2 questions.
1. Have you seen any indications that hair cell regeneration will treat tinnitus in cases where tinnitus was a consequence of hearing loss be it noise induced or ototoxicity induced?

2. When do you plan to start human trials and how do you sign up?

First, no. Not yet. The prevailing theory for the cause of tinnitus has more to do with damaged nerve ending than hair cells. That said, the hearing loss pill has shown to be effective in treating tinnitus. This confirms the theory. However, if it is or can be related to hair cell damage, then our hearing loss injection would be a possible treatment for it. Commercialized product expectations: Pill = Mid-2020s. Injection - Late-2020s.

Second, The Pill - already started. Awaiting Phase II. The Injection - hopefully in a year, maybe two.

 

[Justin De Moss]

Thanks.

For clarification, are you part of Hough Ear Institute since you said "our researchers and CEO"?

Yes, I am. I'm the one quoted above in the emails.

 

[Justin De Moss]

@Justin De Moss

Why has Hough Ear Institute not published any papers in academic peer reviewed journals?

Is it possible you are just trying to raise funds for a miracle drug that will never see the light of day?

To answer your first question - we have. Lots. If you go to our website you can find all the publications there.

Your second question: No. I gave up a job raising money for another non-profit that would have paid me three times as much as I am making now. I know the researchers and the CEO. That is why I choose to move my family (all nine of us - yes nine of us) to Oklahoma City.

Here's the deal - we have all been told multiple times that "X" is the cure. We buy into X and try it and no go. Then we try "Y" and the same result. In some respects, our suffering has been taken advantage of. At the same time, I think our expectations are a little jaded. No one can promise you that they have a cure. If they do - they don't know real science. We think we might have a treatment or a cure. Our data has been very robust - as indicated by the published research. We hope. I won't over-promise you. For those who want to support the research - great. For those that don't - that's fine too. There are enough people in the world that want to see this happen and if we don't do it, someone else will. The only question is will the organization be able to bring the treatment/cure to the market before the patent expires. Once that happens - it's game over. I could have a drug that cures all cancer, Parkinson's, etc. but if its patent is expired - it will never get to market.

 

[Dizzyhead888]

In order,

1) Tinnitus - Yes, the hearing loss pill has already shown to be effective in treating it. Hyperacusis - possibly. We haven't run a study on that yet, but that doesn't mean we won't in the future.

2) In phase I, only toxicology is/was tested. Phase II studies check for toxicology and efficacy.

3) Not sure what you mean by this question. It is already super safe for humans - so I don't know how we would/could make it safer?

4) The protocols for the Phase II study will be announced by our biotech partner and we will share that information in our newsletter and Facebook account. The best way to keep up to date on that is to sign up for our newsletter. We don't spam people, share information, rent our lists, etc. All your information stays private and with us. Yes, tinnitus and or hearing loss.

5) That's a longer discussion. The short of it is that we use existing cells, silence the RNA and become new hair cells. In completely layman's terms This is a novel approach that others have not taken and one of the reasons we have had so much success.

6) I can't really answer that specifically, to be honest. I don't know much about the other therapies since I'm a layman, not a scientist. However, I did share the Frequency Therapeutics with our CEO and he said it is different. We are going to discuss it further when he gets back from his trip to Vietnam where he is helping build a cochlear implant program of excellence in Hanoi. The takeaway message he gave me is that they are different and we are much further along than they are based on what he read. Please note, however - these conclusions are based on very limited data. They are not definitive. We'll have a better answer in the future when we can dive into their data more.

7) Phase II and III trials generally take 2 years each. That fits the time estimation well if anything it is conservative with the assumption that we will have the funding to advance the research.

8) We are a research institute, not a biotech firm. We seek innovation to get products to biotech firms to commercialize it. So, no - we don't have any investors other than people who donate to advance the research.

9) The best thing to continue to our work is to spread the word. Our research team is small as is our budget. But we have been able to do extraordinary things that much larger research outfits have not been able to. We need prayers. We need funding. We need people to be aware of the great work being done in Oklahoma City.

Thank you for asking such great questions! I'm with you. I want a solution to end people suffering.

I can't thank you enough for taking the time and addressing our questions. I am sure the whole Tinnitus Talk community appreciates that. I will donate myself to your research and encourage everyone here to do so too.

 

[JohnAdams]

First, no. Not yet. The prevailing theory for the cause of tinnitus has more to do with damaged nerve ending than hair cells. That said, the hearing loss pill has shown to be effective in treating tinnitus. This confirms the theory. However, if it is or can be related to hair cell damage, then our hearing loss injection would be a possible treatment for it. Commercialized product expectations: Pill = Mid-2020s. Injection - Late-2020s.

Second, The Pill - already started. Awaiting Phase II. The Injection - hopefully in a year, maybe two.

Sorry, last question:
Is the pill for chronic cases or just acute or both?

 

[ajc]

To answer your first question - we have. Lots. If you go to our website you can find all the publications there.

Your second question: No. I gave up a job raising money for another non-profit that would have paid me three times as much as I am making now. I know the researchers and the CEO. That is why I choose to move my family (all nine of us - yes nine of us) to Oklahoma City.

Here's the deal - we have all been told multiple times that "X" is the cure. We buy into X and try it and no go. Then we try "Y" and the same result. In some respects, our suffering has been taken advantage of. At the same time, I think our expectations are a little jaded. No one can promise you that they have a cure. If they do - they don't know real science. We think we might have a treatment or a cure. Our data has been very robust - as indicated by the published research. We hope. I won't over-promise you. For those who want to support the research - great. For those that don't - that's fine too. There are enough people in the world that want to see this happen and if we don't do it, someone else will. The only question is will the organization be able to bring the treatment/cure to the market before the patent expires. Once that happens - it's game over. I could have a drug that cures all cancer, Parkinson's, etc. but if its patent is expired - it will never get to market.

Thanks, it's just that if you genuinely had a cure for hearing loss or tinnitus at your fingertips, I'm sure Johnson & Johnson, Roche, Pfizer, Novartis, Bayer, GlaxoSmithKline, Merck & Co, or one of the many other ones would happily cover the costs of the trials and take this thing to market as soon as possible.

To me you sound a bit like a preacher, you believe in your product a little too much. Remember that like 80% of drugs fail before reaching end of phase 3 clinical trials.

You don't see any risks or possibilities of failure? If you were to give your drug NOW to a person with severe hearing loss and tinnitus, you think they would be cured?

 

[Dizzyhead888]

In order,

1) Tinnitus - Yes, the hearing loss pill has already shown to be effective in treating it. Hyperacusis - possibly. We haven't run a study on that yet, but that doesn't mean we won't in the future.

If you don't mind me asking, how was it already shown to be effective in treating tinnitus? Was this based on clinical trials? In animals or humans? Are there any results to read?

I went through the website and through the email exchanges received from Hough. You seem to be very optimistic, saying that your drug works.

We just would like to kindly know what the optimism is based on?

2) In phase I, only toxicology is/was tested. Phase II studies check for toxicology and efficacy.

I acknowledge that phase 1 of clinical trials are focused on safety. However, some clinical trials do report interim results of efficacy.

Wasn't there interim results of efficacy from phase I?

 

[Rb86]

@Justin De Moss thank you so much for opening the lines of communication with Tinnitus Talk. It's really wonderful. Thank you.

 

[Justin De Moss]

Sorry, last question:
Is the pill for chronic cases or just acute or both?

No worries at all. I love bragging about our research team and their efforts! Our pill technology regenerates the nerve ending between the cochlea and the auditory nerve. So, both in a sense.

It not only restores a meaningful connection with the nerves, but it also prevents them from being damaged in the first place. It was originally designed for the military. They are in a firefight for their lives, they can't stop and put on ear protection. However, the process the noise trauma causes begin after 24 hours and take several days to occur. The pill stops that process cold. We later discovered that it worked in a restorative function as well. Then we tested it with tinnitus. All with great data to support its efficacy.

 

[Justin De Moss]

Thanks, it's just that if you genuinely had a cure for hearing loss or tinnitus at your fingertips, I'm sure Johnson & Johnson, Roche, Pfizer, Novartis, Bayer, GlaxoSmithKline, Merck & Co, or one of the many other ones would happily cover the costs of the trials and take this thing to market as soon as possible.

To me you sound a bit like a preacher, you believe in your product a little too much. Remember that like 80% of drugs fail before reaching end of phase 3 clinical trials.

You don't see any risks or possibilities of failure? If you were to give your drug NOW to a person with severe hearing loss and tinnitus, you think they would be cured?

I can appreciate your point of view. However, I have to say that you are dead wrong on your assumption about big pharma. Way too in-depth to get into on a forum - but we will be having a video that explains the process and how our business model fits into that. Probably after the turn of the year.

You are right about drugs failing. I'm very careful and if you look back, you'll see I never promise anything. I say things like the data supports, robust data, etc. That is what you need to look at when evaluating an organization. Peer-reviewed journals have highlighted our findings. The US Government gave us and only us out of over 70 applicants, a grant to advance the research through phase I.

Yes, we may fail in Phase II. We might fail in Phase III. But based on the data, and that we didn't have to increase the sample size for statistical significance, and the compound is made up of two drugs, one of which is already FDA approved - I have high hopes!

To be clear though - yes. We might fail to bring a product to market. That is a real possibility for everyone in this.

 

[Justin De Moss]

If you don't mind me asking, how was it already shown to be effective in treating tinnitus? Was this based on clinical trials? In animals or humans? Are there any results to read?

I went through the website and through the email exchanges received from Hough. You seem to be very optimistic, saying that your drug works.

We just would like to kindly know what the optimism is based on?

I acknowledge that phase 1 of clinical trials are focused on safety. However, some clinical trials do report interim results of efficacy.

Wasn't there interim results of efficacy from phase I?

The tinnitus studies were pre-clinical (i.e. animal). We are, with the aid of another proof-of-concept study going to go straight to phase II with the indication of tinnitus. My optimism comes from the research staff, their research, and the data. I would say it "appears" that our drug works. Nothing is certain and anyone telling you otherwise is selling you snake oil. In our Phase I trial, the grant covered the typical - solely toxicology aspects of the drug. The added expense and small sample size make any efficacy claims very, very suspect.

 

[FGG]

Just wanted to chime in and give my "google review" of Dr. Kopke (head of research at Hough).

I saw him as a patient this summer (he still needs to call me back again but I know he is extraordinarily busy ) and I have to say, I was very impressed.

For starters, he took the most thorough history of any doctor I have seen. My case is pretty complicated and he took the appropriate time to understand all the specifics. He also said something that I have only heard other veterinarians and never MDs say which was "I have much more to research about your case and will get back to you."

I found him sincere, humble, knowledgeable, open minded and genuinely caring. Actually, I can say the same about everyone I met at the clinic.

I live on the East Coast and, at this point, I wouldn't see another Otologist. I can't speak for the research but I trust him and I trust Hough.

 

[Chriscom]

To answer your first question - we have. Lots. If you go to our website you can find all the publications there.

Your second question: No. I gave up a job raising money for another non-profit that would have paid me three times as much as I am making now. I know the researchers and the CEO. That is why I choose to move my family (all nine of us - yes nine of us) to Oklahoma City.

Here's the deal - we have all been told multiple times that "X" is the cure. We buy into X and try it and no go. Then we try "Y" and the same result. In some respects, our suffering has been taken advantage of. At the same time, I think our expectations are a little jaded. No one can promise you that they have a cure. If they do - they don't know real science. We think we might have a treatment or a cure. Our data has been very robust - as indicated by the published research. We hope. I won't over-promise you. For those who want to support the research - great. For those that don't - that's fine too. There are enough people in the world that want to see this happen and if we don't do it, someone else will. The only question is will the organization be able to bring the treatment/cure to the market before the patent expires. Once that happens - it's game over. I could have a drug that cures all cancer, Parkinson's, etc. but if its patent is expired - it will never get to market.

When does the patent expire?

Separately, I don't totally understand the process your pill is said to generate, but for the moment I'll wait to re-examine what's said here and at your site, and perhaps the company can elaborate in the Tinnitus Talk Podcast which I strongly encourage Hough to participate in! Thanks for engaging here, I really appreciate it.

 

[amillar1993]

What an awesome thread this turned out to be.

The timescales are slightly disheartening, but it sounds like things are moving in the right direction.

 

[all to gain]

Third, Yes. Research is expensive. To get the attention of "big pharma" we need to get the research through Phase I, possibly even Phase II clinical trials. That equates to roughly 30-40 million dollars over the course of 10-12 years.

Maybe you already answered, I'm not sure, but where are you looking to get this funding from? And how likely is it that you will get it? And, are things on hold until you get the funds?

 

[JohnAdams]

Well, from some light research, it looks like the tinnitus pill they have is HPN-07 plus NAC.

"We are initiating a Phase 1b safety and pharmacokinetics trial for our candidate otoprotectant formulation, an oral, fixed-dose combination of two antioxidant molecules HPN-07 plus n-acetylcysteine (NAC). Next, HPN-07 plus NAC will enter a Phase 2 trial next year for the treatment of noise-induced hearing loss."

https://www.prnewswire.com/news-rel...y-from-the-hough-ear-institute-300150403.html

Most of us probably already have a bottle of NAC, here is the other ingredient:

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=US

It's orally administered, so no doctor needed for an injection.

 

[Daniel Lion]

Well, from some light research, it looks like the tinnitus pill they have is HPN-07 plus NAC.

"We are initiating a Phase 1b safety and pharmacokinetics trial for our candidate otoprotectant formulation, an oral, fixed-dose combination of two antioxidant molecules HPN-07 plus n-acetylcysteine (NAC). Next, HPN-07 plus NAC will enter a Phase 2 trial next year for the treatment of noise-induced hearing loss."

https://www.prnewswire.com/news-rel...y-from-the-hough-ear-institute-300150403.html

Most of us probably already have a bottle of NAC, here is the other ingredient:

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=US

It's orally administered, so no doctor needed for an injection.

Errrrrrrrrrrrr.

Was this not the pill for acoustic shocks, to be ingested after exposure to, for example, an explosion?

Why would @Justin De Moss discussing everything except @ajc question about Big Parma's being interested in sponsorship not be acceptable for this forum. "It would take too long" to discuss here.

I am feeling jaded and disillusioned... sorry...

@FGG had a cool experience and I really respect her... that's big, but, it was a consultation and I believe it was, let me ponder this and I'll get back to you... fair play.

Dr. Kopke going to Vietnam to to charity work... awesome... I like.

"Our business model we will reveal in the upcoming year but can't explain that right now"... eaves me dubious... plain dubious.

Real nice guy, Oklahoma... very cool... again leaves me dubious... I guess I am an old school conformist... Names like Stanford, MIT, Harvard... etc... I get excited about. Fear of patents running out and yet operating as a nonprofit?

When I first read about Hough Ear Institute I got super excited... they sound wonderful...
Maybe they are the real deal... I am tired...

Freaking Bill Gates, or Mr. Facebook could finance these guys for the next decade...

I don't get it.

 

[Coleoptere]

And I assume this is the study .... https://clinicaltrials.gov/ct2/show/NCT02259595

.... and another one: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4010594/

 

[JohnAdams]

If this pill is already been shown to be safe, why can't we try it now? Why should it need to take 5 more years given that there is an urgent need for something like it?

Why do they have to prove its efficacy before we are allowed to try it? Why can't I sign a release stating that I know it may not be efficacious? If it's safe then what's the problem? What are our soldiers even fighting for? I thought we were supposed to have liberty in this country.

 

[Coleoptere]

We want a commercialized treatment ASAP! And one that is affordable so we can take it to the 600+ million people worldwide suffering right now.

It is certainly not the Hough Ear Institute that is holding this back as they are genuinely committed to help us out.

HPN-07 is the component which has to pass FDA. It has synonyms:

Synonym: Disodium 4-[(tert-butyl-imino) methyl]benzene-13-disulfonate N-oxide, 2, 4-Disulfonyl PBN, 2,4-Disulfophenyl-N-tert-butylnitrone, ARL 16556, CPI 22, Cerovive, Disufenton sodium, NXY-059, Nxy 059, OKN-007, OKN007, Oklahoma nitrone-007

... and is now also in a pre clinical trial for Pediatric Glioblastomas under the name Nitrone 007 (OKN-007). It would be a shame if a second safety test is required for it. As NXY-059 (Disufenton sodium) it was part of a failed trial.

 

[JohnAdams]

It is certainly not the Hough Ear Institute that is holding this back as they are genuinely committed to help us out.

HPN-07 is the component which has to pass FDA. It has synonyms:

Synonym: Disodium 4-[(tert-butyl-imino) methyl]benzene-13-disulfonate N-oxide, 2, 4-Disulfonyl PBN, 2,4-Disulfophenyl-N-tert-butylnitrone, ARL 16556, CPI 22, Cerovive, Disufenton sodium, NXY-059, Nxy 059, OKN-007, OKN007, Oklahoma nitrone-007

... and is now also in a pre clinical trial for Pediatric Glioblastomas under the name Nitrone 007 (OKN-007). It would be a shame if a second safety test is required for it. As NXY-059 (Disufenton sodium) it was part of a failed trial.

Right, it is the FDA. The FDA is the villain. We need something like the FDA, but big pharma has, through lobbying and the revolving door between government and corporations, transformed a needed regulatory process, into an artificial barrier to entry which protects the market from disruptive products.

 

[Coleoptere]

I send them a mail, who knows.

 

[all to gain]

It baffles me that out of all the mega rich people (billionaires + millionaires), no one has moderate to severe tinnitus to fund research.

I know Richard Branson has hearing loss, I don't know if he has tinnitus.

What we really need is someone like Prince Harry in the UK to take up the cause. He is ex military and will certainly know of people suffering from tinnitus. He obviously supports a lot of other causes though, and maybe tinnitus would be seen as not enough in people's faces to warrant supporting.

https://www.royal.uk/The-Duke-of-Sussex

 

[JohnAdams]

Prince Harry

I'm pretty sure that he actually has no power and is a vestigial figurehead. Corporations are controlled by their preferred stock holders, which are entities that have vast amounts of power that supersede people like Prince Harry.
There is actually very little we can do with regard to affecting regulatory policy because there is just so much money at stake.

The only thing we could really do is organize on social media and make it a part time job to coordinate our message, like propaganda soldiers. We would have to all use VPN's and TOR to create multple ALT accounts to increase visibility. This would be very easily infiltrated and destroyed. Basically Markku would have to recruit us into a private group like a secret society and we would have to plan and execute our operation with laser like precision. That would fail because Markku, as Sovereign Grand Commander of such a group, would actually have no real way to properly vet us, thus cohesion and loyalty would suffer.

There really is nothing we can do without loads and loads of cash. We need cash. Major cash.

 

[Pawel1]

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=GB
I have 2 products in the list, and the cheaper one costs £45. How much of the ingredient, would I receive? Just 1 pill or 5mg of powder? Seems quite expensive.

 

[ajc]

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=GB
I have 2 products in the list, and the cheaper one costs £45. How much of the ingredient, would I receive? Just 1 pill or 5mg of powder? Seems quite expensive.

The company you linked to does NOT sell to private individuals. You need to buy on behalf of a pharmaceutical business to be able to buy from them.

 

[JohnAdams]

The company you linked to does NOT sell to private individuals. You need to buy on behalf of a pharmaceutical business to be able to buy from them.

Stop lying. They will sell to reputable research labs which includes universities.

 

[vttbx]

The company you linked to does NOT sell to private individuals. You need to buy on behalf of a pharmaceutical business to be able to buy from them.

That's correct. I tried many times to buy from Sigma Aldrich and always fail. They sell to research companies only. They won't even sell to a compounding pharmacy. Believe me, I've tried.