Hough Ear Institute's Hair Cell Regeneration Project

[Nick47]

What we really want to know is what happened after Oblato received the license? Why did they decide not to proceed with human clinical trials? They say that Hough Ear Institute cannot decide on compassionate use, yet they post a success story of someone who received it for compassionate use and improved.

 

[Brian Newman]

@Brian Newman, I emailed a little back and forth with Ashley Everett of Hough Ear Institute mentioning this thread and that some here are suspicious about Hough Ear Institute's intentions. I also mentioned you Brian and that you seem to have a really hard time (I have a hard time myself suffering large parts of the day, but you definitely seem worse).

She informed me a bit about the current status of their projects etc. I think it's easier if I simply post Ashley's response here:

"I'm sorry that's the vibe on Tinnitus Talk, but it's best for us to stay away from it. We are a very small institute and if I took time to respond to every comment about HEI online (even just the upset ones) that would be all I do. I know Justin spent time on it, but that's not our policy moving forward. There are a lot of misconceptions that just cannot be cleared up in a social media situation (especially if it's not what people want to hear) without vitriol. It's unfortunate, but it seems to be human nature on the internet.

I can sympathize with this Brian Newman fellow because I have tinnitus, too, and it affects my sleep and ability to hear in crowded spaces. I can't even imagine how infuriating and even painful it is to have debilitating tinnitus and understandably, he is very frustrated. It's people like him – real people who are hurting – who motivate us to find solutions. Grace upon grace for him and anyone else who is upset. I would hope they would also remember HEI is run by actual humans trying their very best to get a treatment for tinnitus to market and offer hope where we can. This isn't just "Hough Ear Institute," it's Matt, Ashley, Weihua, Don, Pam, Richard, Jianzhong, Agnes, etc. We are real people with a passion to bring relief to those who need it.

I will, however, give you a rundown of what he has incorrectly assumed and empower you to respond if you so choose: AOK-1 is our hearing regeneration therapeutic, not NHPN-1010. AOK-1 is licensed by Boehringer Ingelheim and we are working on an IND for submission into Phase I clinical trials as we speak. AOK-1 is also an injection, not a pill. AOK-1 addresses lost/damaged cochlear hair cells through regeneration... which we have successfully done in adult mammals. A photo of one of our regenerated hair cell bundles appeared on the cover of Molecular Therapy (attached is the image of that cover) which was the catalyst for BI licensing it.

NHPN-1010 is a pill and is a nerve repairing, hearing protectant that can address hearing loss due to nerve damage and tinnitus. This is not a hearing restoration therapeutic, but it can restore hearing if only the ribbon synapses are damaged, not the cochlear hair cells.

HEI takes private donations for preclinical work not covered by pharmaceutical companies during clinical development (clinical trials/human testing). Once we license our technology for clinical trials, the timeline is in the hands of the company who licensed it, not us. It is also their prerogative whether or not to offer it for expanded access through the FDA and/or approve supplying it to each individual patient wanting it. It's not HEI denying anyone access to NHPN-1010. It's in our best interest to get it to more people, not less! We want it in clinical trials yesterday, but as explained in my last email, that kind of budget is not feasible for us. If he would like to reach out to Elaine Hamm at Otologic Pharmaceutics, Inc. she can explain the licensing process in more detail and how it works for NHPN-1010 specifically. That's her area of expertise."​

Oh boy, no, she cannot sympathize with me. My tinnitus is not the problem. She's going to work every day, living a normal life, and I'm rotting in a room in extreme pain, getting deep stabbing pain from 20 decibel noises.

What was the misconception? She's making it seem like I'm spreading lies on the internet. I've been pretty honest about everything. They had one person get the drug NHPN-1010 and apparently it helped him. I was next on the list and boom, compassionate use pulled.

Yes, NHPN-1010 restores synapses, not hair cells. Their AOK-1 drug has been in pre-clinical stage for 5 years? They are not going anywhere.

 

[Lucifer]

Does Otologic Pharmaceuticals have the rights to NHPN-1010? I thought the rights were given back to Hough Ear Institute?

Oh boy, no, she cannot sympathize with me. My tinnitus is not the problem. She's going to work every day, living a normal life, and I'm rotting in a room in extreme pain, getting deep stabbing pain from 20 decibel noises.

What was the misconception? She's making it seem like I'm spreading lies on the internet. I've been pretty honest about everything. They had one person get the drug NHPN-1010 and apparently it helped him. I was next on the list and boom, compassionate use pulled.

Yes, NHPN-1010 restores synapses, not hair cells. Their AOK-1 drug has been in pre-clinical stage for 5 years? They are not going anywhere.

I had a look at the patient testimony in the video. What was interesting is that he mentioned that he was in pain from the car ride and the restaurant. I'm assuming this to mean he was in pain from hyperacusis and not pain from tinnitus. No mention if his hyperacusis was the loudness type or the noxacusis/pain type but I think it's more of the latter.

Since Oblato stopped compassionate use, did you end up emailing Otologic Pharmaceuticals about whether they could give you compassionate use?

 

[Brian Newman]

Does Otologic Pharmaceuticals have the rights to NHPN-1010? I thought the rights were given back to Hough Ear Institute?

I had a look at the patient testimony in the video. What was interesting is that he mentioned that he was in pain from the car ride and the restaurant. I'm assuming this to mean he was in pain from hyperacusis and not pain from tinnitus. No mention if his hyperacusis was the loudness type or the noxacusis/pain type but I think it's more of the latter.

Since Oblato stopped compassionate use, did you end up emailing Otologic Pharmaceuticals about whether they could give you compassionate use?

I emailed everybody. They completely dumped me, sadly. I had a talk with Ashley. I'll have to go back and read it again. I'm pretty sure Oblato and Otologic Pharmaceuticals are connected. Either way, whomever was supporting the drug for compassionate use, cancelled it and backed out. That wasn't Hough Ear Institute's fault, but I am upset with them giving it to one person, when I'm literally next in line and get screwed. Then they post all about this guy on their website getting better from the drug. I'm happy if anybody improves their severe tinnitus, hyperacusis or noxacusis. Everybody thought I was being greedy when I was trying to tell them to back off and let me get on the list first. I have read every horror story of noxacusis and hyperacusis and when I figured out I have one of the worst cases I've ever heard of, I realized I need some kind of synaptic regenerative or hair cell regenerative drug to improve this. I have seen very few cases of people completely bedbound because of the severe pain. I've read a few and they're doing a little better now but still homebound. I've never heard of somebody puking for days because the ear pain was so bad. So when I go on here and talk crap, I got a pretty good reason.

Of course most of us on here are suffering and I'm sure that guy had bad tinnitus. He had an acoustic neuroma which can cause nasty tinnitus. I get upset because I've been dealing with moderate tinnitus for 8 years now and in the last 2 years it got pretty bad from all my accidents, and now I have horrific noxacusis. I'm definitely in worse shape than that one guy, and yet they give it to him, spit in my face, parading his story around talking about how it was a miracle! I've been trying to get that drug since 2015. I mean I got this so bad now that if I could leave my house with double protection and not get horrible pain and permanently worse, I would consider my quality of life 80 percent better. I mean people say they're severe when they're walking around town in busy traffic saying everything is hurting their ears! It's so bad! Never have I heard a case of somebody getting severe ear pain from a squeaking door through double protection. So she's right, of course I'm upset. If my ears were stable like 99 percent of the cases I read about, I would be living my life. Or when I see people complaining about how their ears hurt so bad that they have to wear earplugs out in public. Lord, lol.

Now that virtually every hearing drug failed, we have absolutely nothing! PIPE-505 gone, FX-322 gone, FX-345, OTO-313 gone, OTO-413 gone. All we have left is Ebselen, and this drug. Susan Shore's device won't help noxacusis so I'm not counting on that. This entire community is upset that we have had nothing since the beginning of time and all we have is TRT and CBT which don't even work. Yeah, if you're a mild case, of course you can be positive and ignore it. Of course you can mask your tinnitus and feel better. It's easy to ignore moderate pain. All the people who have horrific tinnitus cases what about them? I mean being told to think positive and all the gaslighting crap does not work for true severe cases. I've only met one hyperacusis person in real life but I've met quite a few severe tinnitus cases. And not one was positive and said things like "it made me stronger", or "I was positive and thought it would quiet down and it did!" No, they said it sucks and they want to die. Every single one. That's how I know if people are bad or not. There's definitely some really negative people on forums, and some mild people are super negative and over think stuff. But bad cases will never say anything positive about it. No way lol. Now that I realized I'll be in my room for another few decades, I'm not happy!

 

[Lucifer]

I emailed everybody. They completely dumped me, sadly. I had a talk with Ashley. I'll have to go back and read it again. I'm pretty sure Oblato and Otologic Pharmaceuticals are connected. Either way, whomever was supporting the drug for compassionate use, cancelled it and backed out. That wasn't Hough Ear Institute's fault, but I am upset with them giving it to one person, when I'm literally next in line and get screwed. Then they post all about this guy on their website getting better from the drug. I'm happy if anybody improves their severe tinnitus, hyperacusis or noxacusis. Everybody thought I was being greedy when I was trying to tell them to back off and let me get on the list first. I have read every horror story of noxacusis and hyperacusis and when I figured out I have one of the worst cases I've ever heard of, I realized I need some kind of synaptic regenerative or hair cell regenerative drug to improve this. I have seen very few cases of people completely bedbound because of the severe pain. I've read a few and they're doing a little better now but still homebound. I've never heard of somebody puking for days because the ear pain was so bad. So when I go on here and talk crap, I got a pretty good reason.

Of course most of us on here are suffering and I'm sure that guy had bad tinnitus. He had an acoustic neuroma which can cause nasty tinnitus. I get upset because I've been dealing with moderate tinnitus for 8 years now and in the last 2 years it got pretty bad from all my accidents, and now I have horrific noxacusis. I'm definitely in worse shape than that one guy, and yet they give it to him, spit in my face, parading his story around talking about how it was a miracle! I've been trying to get that drug since 2015. I mean I got this so bad now that if I could leave my house with double protection and not get horrible pain and permanently worse, I would consider my quality of life 80 percent better. I mean people say they're severe when they're walking around town in busy traffic saying everything is hurting their ears! It's so bad! Never have I heard a case of somebody getting severe ear pain from a squeaking door through double protection. So she's right, of course I'm upset. If my ears were stable like 99 percent of the cases I read about, I would be living my life. Or when I see people complaining about how their ears hurt so bad that they have to wear earplugs out in public. Lord, lol.

Now that virtually every hearing drug failed, we have absolutely nothing! PIPE-505 gone, FX-322 gone, FX-345, OTO-313 gone, OTO-413 gone. All we have left is Ebselen, and this drug. Susan Shore's device won't help noxacusis so I'm not counting on that. This entire community is upset that we have had nothing since the beginning of time and all we have is TRT and CBT which don't even work. Yeah, if you're a mild case, of course you can be positive and ignore it. Of course you can mask your tinnitus and feel better. It's easy to ignore moderate pain. All the people who have horrific tinnitus cases what about them? I mean being told to think positive and all the gaslighting crap does not work for true severe cases. I've only met one hyperacusis person in real life but I've met quite a few severe tinnitus cases. And not one was positive and said things like "it made me stronger", or "I was positive and thought it would quiet down and it did!" No, they said it sucks and they want to die. Every single one. That's how I know if people are bad or not. There's definitely some really negative people on forums, and some mild people are super negative and over think stuff. But bad cases will never say anything positive about it. No way lol. Now that I realized I'll be in my room for another few decades, I'm not happy!

I don't know why Hough Ear Institute sold the drug to Otologic Pharmaceuticals/Oblato if they were never going to continue with the trials. They should have added a clause that if they did not start a Phase 2 in a year, they would have to give back the rights to Hough Ear Institute.

What was their reason for stopping the Phase 2 trials? I don't think there was any announcement or mention on why they stopped the Phase 2 trials? I hope somehow they find a way to start the Phase 2 trials.

@Brian Newman, you could ask them what is causing the delay with the Phase 2 trials? It will be a shame to stop the trials after one person had his tinnitus and hyperacusis reduced from it.

If Oblato doesn't start a Phase 2 trial, does this mean Otologic Pharmaceuticals can find a different partner to start the Phase 2 trials with? I would want someone like Spiral Therapeutics buy the rights to the pill.

 

[Brian Newman]

@Brian Newman, you could ask them what is causing the delay with the Phase 2 trials? It will be a shame to stop the trials after one person had his tinnitus and hyperacusis reduced from it.

If Oblato doesn't start a Phase 2 trial, does this mean Otologic Pharmaceuticals can find a different partner to start the Phase 2 trials with? I would want someone like Spiral Therapeutics buy the rights to the pill.

I asked. They wouldn't say why. That's why I was pissed.

 

[Lucifer]

I asked. They wouldn't say why. That's why I was pissed.

Did you ask Otologic Pharmaceuticals or Oblato?

I would ask Hough Ear Institute whether someone else could buy the rights or start the trials without Otologic Pharmaceuticals and Oblato involvement. No one should be allowed to keep the rights of the pill if they aren't going to continue with the trials.

 

[Brian Newman]

Did you ask Otologic Pharmaceuticals or Oblato?

I would ask Hough Ear Institute whether someone else could buy the rights or start the trials without Otologic Pharmaceuticals and Oblato involvement. No one should be allowed to keep the rights of the pill if they aren't going to continue with the trials.

I asked all three. I got the same crap answer.

 

[ErikaS]

I asked all three. I got the same crap answer.

Do you have a current doctor who could contact them and speak on your behalf? It's just such BS how they waved the "compassionate care use" flag with this, gave it to one person that they publicly discussed and "bragged" about how it worked for him, then it was pulled??? So wrong and just awful as you were literally next. Therefore I was just wondering if your current doctor could present your case to them in a firm manner and strongly request a reconsideration for you. You probably thought of all of this already, just wanted to put my thoughts out there and share my frustration for you.

 

[JimmyStrong]

I got the same crap answer.

Which was?

 

[Brian Newman]

Do you have a current doctor who could contact them and speak on your behalf? It's just such BS how they waved the "compassionate care use" flag with this, gave it to one person that they publicly discussed and "bragged" about how it worked for him, then it was pulled??? So wrong and just awful as you were literally next. Therefore I was just wondering if your current doctor could present your case to them in a firm manner and strongly request a reconsideration for you. You probably thought of all of this already, just wanted to put my thoughts out there and share my frustration for you.

Thanks. I agree. The fact that they're showing off how their drug fixed the one guy makes me so angry. I haven't talked to most of my doctors in a while. Just my neurologist. Sadly, coming up with a good case won't change anything because when I emailed everyone, they all said sorry, Oblato decided to pull compassionate use, you can't get it if you tried. The guy I talked to was from Oblato. He said it was his superior's decision and he doesn't know why they pulled it; they never gave him a reason. They just pulled it and that's it. I don't think it could help too much. If it does regenerate synapses like they said, it definitely could, but I have a hard time believing it would help a lot because it's oral. The drug needs to get in the cochlea.

I just think it's wrong how they're trying to hype up their drug so much when it will probably never come out. They're toying with all of us. I mean their Phase 1 was completed in 2014. Lol.

 

[Ava Lugo]

Thanks. I agree. The fact that they're showing off how their drug fixed the one guy makes me so angry. I haven't talked to most of my doctors in a while. Just my neurologist. Sadly, coming up with a good case won't change anything because when I emailed everyone, they all said sorry, Oblato decided to pull compassionate use, you can't get it if you tried. The guy I talked to was from Oblato. He said it was his superior's decision and he doesn't know why they pulled it; they never gave him a reason. They just pulled it and that's it. I don't think it could help too much. If it does regenerate synapses like they said, it definitely could, but I have a hard time believing it would help a lot because it's oral. The drug needs to get in the cochlea.

I just think it's wrong how they're trying to hype up their drug so much when it will probably never come out. They're toying with all of us. I mean their Phase 1 was completed in 2014. Lol.

Yeah, I would be pissed too. I agree, I think the drug would help better if we could inject it in the cochlea. I want to believe we might have something that can help us within 5 years but I don't know.

 

[Brian Newman]

Yeah, I would be pissed too. I agree, I think the drug would help better if we could inject it in the cochlea. I want to believe we might have something that can help us within 5 years but I don't know.

I wish. Unless gene therapy doesn't need 10 years for trials, we're looking at next decade for hearing regeneration. It's pretty sad and horrible. Susan Shore is good but for noxacusis, with the exception of maybe XEN1101, we got nothing

 

[JimmyStrong]

I wish. Unless gene therapy doesn't need 10 years for trials, we're looking at next decade for hearing regeneration. It's pretty sad and horrible. Susan Shore is good but for noxacusis, with the exception of maybe XEN1101, we got nothing

IMO gene therapy is probably going to need 10 years just for clinical trials. It seems like a very complicated task to complete compared to other methods.

 

[dj_newark]

I've asked Dr. Shore if she will be presenting any new information at the conference she'll be speaking at in France this September. She just said:

I don't know - depends on if the publication is out yet.

 

[tomytl]

There is new information about the development of NHPN-1010:

NHPN-1010 Clinical Development (houghear.org)

 

[Nick47]

There is new information about the development of NHPN-1010:

They should give a breakdown of costs? How can two clinical trials and FDA approval cost $500 million?

Here are the average costs of clinical trials in the USA. How can these con artists claim they need $500 million? Go swing.

Many stakeholders + different costs = complex clinical trial (Part 1)

 

[DimLeb]

There is new information about the development of NHPN-1010:

NHPN-1010 Clinical Development (houghear.org)

I don't see how that's new. They've been at the stage of begging money for trials since 2014...

 

[JimmyStrong]

I don't see how that's new. They've been at the stage of begging money for trials since 2014...

You would think, after so much begging for money since 2014, that they would need less than $500 million dollars. That's a gigaton of money. Even if this thing is the real deal, I doubt these guys will receive the funding. It's essentially dead in the water.

 

[Jupiterman]

If the drug was that promising or, dare I say it, worked well, would they need to beg for money?

And to ask for half a billion?

I smell a rat!

 

[DimLeb]

You would think, after so much begging for money since 2014, that they would need less than $500 million dollars. That's a gigaton of money. Even if this thing is the real deal, I doubt these guys will receive the funding. It's essentially dead in the water.

It's funny, because, if you gave that amount of money to any random person who knew absolutely zero about medical companies, medical research, trials, medicine science etc, they would probably be able to start their own tinnitus treatment campaign and even come up with a real treatment.

With half a billion, you could even build a rocket like Elon Musk.

 

[tomytl]

It's funny, because, if you gave that amount of money to any random person who knew absolutely zero about medical companies, medical research, trials, medicine science etc, they would probably be able to start their own tinnitus treatment campaign and even come up with a real treatment.

With half a billion, you could even build a rocket like Elon Musk.

And all this "just" for a protective pill.

How much their regenerative program would cost?

 

[Brian Newman]

They should give a breakdown of costs? How can two clinical trials and FDA approval cost $500 million?

Here are the average costs of clinical trials in the USA. How can these con artists claim they need $500 million? Go swing.

Many stakeholders + different costs = complex clinical trial (Part 1)

Lol $500 million. I hurt my ears from laughing so hard.

 

[obnoxious]

There is new information about the development of NHPN-1010:

NHPN-1010 Clinical Development (houghear.org)

Charlatans.

 

[JimmyStrong]

And all this "just" for a protective pill.

How much their regenerative program would cost?

A protective pill that might not even work. If it was something like a regenerative pill that has been proven to show some decent results, I would back it up, but it's not even that.

They should give a breakdown of costs? How can two clinical trials and FDA approval cost $500 million?

Here are the average costs of clinical trials in the USA. How can these con artists claim they need $500 million? Go swing.

Many stakeholders + different costs = complex clinical trial (Part 1)

It seems like even if they receive the funding, we are going to wait for 8+ years under false hope, only to end up with a failed project and some people walking out with a crazy amount of profit. These guys should really give us a breakdown of the costs, it's the least they could do.

 

[tomytl]

I really don't get Hough Ear Institute.

They have talked about their "blast" pill for decades, but nothing has really come out of it.

On the other hand, there are abstracts available about their regenerative program:

Gene therapy for hair cell regeneration: Review and new data

So they seem to do research, but nobody knows what's really going on.

 

[Lucifer]

I wonder if they could sell the rights for NHPN-1010 faster if they highlighted some of the successful patients in the Phase 1 clinical trial. They are bound to have hearing loss and tinnitus.

The only successful story that they highlighted is Max but, whether his hearing loss was restored and tinnitus and hyperacusis reduced due to NHPN-1010 or time, we don't know, unless they test it with more patients.

Where did they get the $500 million dollar amount? It seems ridiculous for Phase 2 and Phase 3. This should be around $150 million ($50 million for Phase 2 and $100 million for Phase 3). Is the $500 million including the production cost of coming out in the market?

 

[Cal18]

I realized I need some kind of synaptic regenerative or hair cell regenerative drug to improve this.

Have you thought of exosome injections into the ear? If you're in the US, this doctor will do them and also make house calls. I've received the exosomes but only as facial injections and intranasal. They don't help much for tinnitus but he has seen good improvement for some patients with hyperacusis.

Happiness is... when you know you made a difference

 

[Brian Newman]

Have you thought of exosome injections into the ear? If you're in the US, this doctor will do them and also make house calls. I've received the exosomes but only as facial injections and intranasal. They don't help much for tinnitus but he has seen good improvement for some patients with hyperacusis.

Happiness is... when you know you made a difference

Thanks for the information. I have read about him and I was considering it. There's another place called Advanced Rejuvenation in Sarasota who do intratympanic injections too. They offer stem cells, PRP, and exosomes. I will try it eventually but I'm still pretty sure no matter what we inject through our eardrums, it won't get into the cochlea. I'm not about to inject $20k worth of stem cells, or $5k worth of exosomes, lie on my side for 30 minutes, and then, as soon as I sit up and swallow, have it drain all out.

 

[ColinUK]

Would it really be so hard to find investment to push this to market if there was compelling evidence that it worked?

I mean didn't the USA Govt also give them funding? It just makes no sense at all.

Is this just utter incompetence by the people in charge or a big con to try to stay relevant and get more donations? Either way is shocking but I really don't know how things work in the USA.