Hough Ear Institute's Hair Cell Regeneration Project

[Daniel Lion]

How many pills would they give @JohnAdams?

How many pills can you pack into a U-Haul truck... the dude is an animal... he's going to need a lot.

 

[JohnAdams]

Are there any people who think someday a cure is coming?

Yes

 

[Jurger]

Yes

Yeah, depending on what people mean by 'cure'. Cure meaning bat-like hearing you had when you were a kid, or a decent amount of hearing restoration, dependent on the loss a patient started out with and quieting of tinnitus? I think hearing/tinnitus will always be our weak spot. That doesn't mean we can't expect significant improvement with future treatments and the increase of quality of life that goes along with that.

 

[GregCA]

Are there any people who think someday a cure is coming?

Yes, there are.

 

[Josdela]

Are there any people who think someday a cure is coming?

Look at all that humanity has built, if we patients give up who will think for us.

 

[SouthKorean]

Yes, there are.

I'm sure it'll heal.

 

[JohnK]

Are there any people who think someday a cure is coming?

Yes, absolutely, on a long enough time horizon. And I don't need a cure. I'd just like a reduction.

 

[Justin De Moss]

@Justin De Moss

Correct me if I'm wrong. I seem to recall reading that Hough Ear Institute has a 7 year patent on their mechanism and the next step is to attract a larger biotech company to take on the drug and support clinical testing.

I was talking to my dad about this (who has spent is life in pharmaceuticals, seeing drugs through infancy to market) and he was saying 7 years is not nearly long enough a patent to attract the large biotech companies. He said, whether necessary or not, they much more often like to see 15-20 year parents so that they can maximize profits on the back end after the usual 10 years of clinical testing.

Hopefully, should we see more results, Hough Ear Institute can extend their patent.

The patent is for 20 years typically. We still have time, but that window is closing. Our next big hurdle, as it relates to tinnitus, is to do a "proof-of-concept study" for the pill and tinnitus. We have already run three studies with amazing results. To get the pill in Phase II for the indication of tinnitus requires one more study with great results.

We are working hard to get there. Quite a few people here have donated and all of those donations have been earmarked for the tinnitus study.

 

[Justin De Moss]

@Justin De Moss

Not too sure if this has been answered yet or not but... If Phase 1 ended in 2015 why was there a delay in starting Phase 2? You could have been in Phase 3 or entered the market by now?

Funding has prevented us from doing it ourselves. The Phase II study is approximately 7 million dollars. We are in negotiations with a couple of different biotech firm rights now to take the pill and even the injection technology forward.

I hope to be able to share some great and exciting news in the next month or two!

 

[Justin De Moss]

Thank you for answering all our questions. I was wondering what Hough's thoughts are on the limitations of intratympanic injections. I've read that it limits the bioavailability of the drug in the cochlea, both because there's a chance of drug leakage through the eustachian tube and because of individuals' lack of permeability of their round window membranes and/or because some drugs have a particular hard time permeating. The result seems to be that it's hard to get enough of the drug in the cochlea, let alone that drug reaching the apex of the cochlea where the lower frequencies are.

There's been a lot of discussion in the literature about the delivery method being crucial for these upcoming hearing loss drugs so I would love your thoughts on that, particularly because you are developing your own intratympanic delivered drug. Are you considering trying novel delivery methods that have advantages over intratympanic injections in terms of bioavailability, like intracochlear injections or nanoparticle delivery?

Great question. We are currently trying to get Dr. Rick Kopke on the Tinnitus Talk Podcast. This would be a great question for him.

Our hearing loss injection (which regrows hair cells in adult mammals) is still in pre-clinical studies. However, our data was featured in Molecular Therapy. That injection use nanoparticles for payload delivery. Dr. Youm, one of our researchers, has increased its efficacy many times over. Exciting things are happening right here in OKC!

 

[Justin De Moss]

Wait a minute. I'm not trying to be rude, but @Justin De Moss, if you yourself have tinnitus and the pill has been proven safe and effective. What is stopping you from trying it yourself? I mean, you actually work for the company. Wouldn't it be easy for you to try it, and then you will know without a shadow of a doubt whether or now it actually works.

Hi Aaron,

No worries. You are not being rude. You are frustrated. I get it.

The short answer to your question is ethics. It would be unethical for me to try it or any of the doctors researching it. It could also jeopardize the research and any deal we could make with a biotech firm would NEVER happen - because we would have demonstrated that we are not ethical/honest. Why would they trust our data. Additionally, while we believe the compound is safe and that conclusion has been supported by all the data up to this point - there is a reason why the FDA has three clinical phases, all of which check for toxicology. We need to go through all three to ensure the drug's safety.

There are factors that we cannot control - the process for example. However there are things within our control. We can write letters, talk to researchers, etc. and try to improve the process through civil discourse. We can also support this and other research important to us. Research is driven by funds - plain and simple. If we had 7 million dollars in 2016 - we wouldn't be having this conversation. The pill would be through Phase II and possibly even through Phase III. Spread awareness of the research being done. It takes people of all kinds of means to come together for a common purpose and make the research happen as fast as it can.

 

[Justin De Moss]

@Justin De Moss how do I donate to your company?

Go to houghear.org. There you can learn more, read peer-reviewed journals on our findings, donate to advance the research, and sign up for our newsletter - where we will announce clinical trials.

 

[Justin De Moss]

I don't think it's been tested on humans yet, let alone dosing figured out.

The pill has been tested on humans. We completed the Phase I clinical study. Ready for Phase II (dosing, efficacy, etc...)

 

[Justin De Moss]

Hough Ear? Maybe we should start with Dr. De Moss and see what he thinks?

Good morning. It's just Mr. De Moss, not Dr.

I think writing letters to improve the system is always a great idea. It has to be more than letters though. It needs to be researchers who are frustrated with the system and how it works who have keen insights that will allow for safety to be the highest priority but also streamlining the process to be more efficient. Of course, it all needs to be done in a civil manner otherwise the powers that be will just write it off immediately.

 

[Justin De Moss]

I think we should have two goals in mind when taking action:

1. Accelerating testing/research, meaning:
a. funding
b. bitching to decision makers hearing loss and/or tinnitus is crap and should have priority, not to mention carries significant societal costs

2. expanded use programs for potential hearing loss drugs that have made it past a phase 2a trial, when there should be a pretty clear picture of safety, efficacy and dosing

Agreed. Maybe not bitching, but offering solutions from experts in the field!

 

[Justin De Moss]

Do you only need funding to conduct phase 2 trials? Can we raise the necessary amount and become volunteers ourselves? How much are we talking about?

Raising support to advance research is a great idea. However, the selection for who gets to be in the trials is not done by HEI, rather the biotech firm.

 

[Justin De Moss]

Thank you but I am nothing like that at all. I just have a medical background and am utterly obsessed with trying to learn everything I can to try and get my life back. I used to be so joyful.

I learn so much from everyone here. I'm so glad this place exists.

Ditto - you guys and ladies are great! Thank you for being so welcoming and civil!

 

[Justin De Moss]

Considering that this treatment has been stuck in trial purgatory for years, looks to me like the process itself is unethical.

Why should we have to wait 5 more years to try this? We shouldn't. Our government is failing us. You should be allowed to resume testing this TODAY.

There is not one good reason whatsoever why you shouldn't be allowed to do that.

What I want to know is EXACTLY why you can't. What s the specific reason you cannot begin recruiting right now? What is holding this up?

I'm so sick of these mysteries.

It's not that we can't move forward in the sense that the FDA is stopping us or some regulation says wait. It is about funding! Simple as that.

A phase II clinical study will cost approximately 7 million dollars. We can't order supplies, hire additional researchers, or outsource the research to the labs that do this day in day out without the ability to pay for it.

So we are allowed, but can't because we cannot afford it on our own currently. Hence, we need to either raise the funds to advance the research or sign a deal with a biotech company to take the research through Phase II and Phase III.

 

[Justin De Moss]

We need to find out exactly why Hough Ear is waiting to continue these trials. Surely it is because someone at the FDA has not given them the green light to do so. We need to figure out who that is.

It's not the FDA, it is funding.

 

[Justin De Moss]

Why not just market this pill as a supplement and make no specific claims? If it works, word of mouth will spread like wildfire.

Sorry, this just isn't possible. The compounds are regulated.

 

[Justin De Moss]

But they would miss out on millions of $ surely?

HEI won't make millions. The biotech firm that invests (50-110 million dollars) in our research and licenses it - they will make a lot of money. They should after fronting all that money, to begin with. Plus fronting money for the other 9 drugs that fail.

 

[Justin De Moss]

Maybe we can get a reaction from @Justin De Moss on some of the questions we posed? What's been holding up Phase 2 of the pill? If it's funding, how much would you need? Do you have enough funding to start Phase 1 of your injection? What about the limitations of intratympanic drug delivery? What's Hough's view on alternative delivery methods? Are you worried you might not get a high enough concentration in the cochlea with intratympanic drug delivery? What about reaching the apex of the cochlea?

Thanks in advance.

I think I answered all these in the post I did this morning. Sorry I've been away for several days. We have an event coming up that has all hands on deck! If I missed anything, please call me out!

 

[Justin De Moss]

Now the question remains: will Hough do that? I think I know the answer.

I don't know. This is above my pay grade However, when Dr. Kopke gets back from Vietnam, I'll bring it to his attention and coming back with some insights. This also would be a great question to ask during the Tinnitus Talk Podcast!

 

[Justin De Moss]

Are there any people who think someday a cure is coming?

I do. But I'm biased

 

[Piney]

Why not team up with Frequency Therapeutics? Sure they have their method, but maybe they could add another. They just received plenty of funds? Just a thought.

 

[Coleoptere]

Ditto - you guys and ladies are great! Thank you for being so welcoming and civil!

@Justin De Moss Thank you so much for your responses. It is really appreciated!

 

[JohnAdams]

I do. But I'm biased

What do you think about this?

Several of us including myself have experienced significant relief from taking curcumin.

Tinnitus patients have lower BDNF levels:
"Serum BDNF level was found lower in the tinnitus patients than controls"
https://www.ncbi.nlm.nih.gov/pubmed/28615544

Curcumin increases BDNF levels:
curcumin at doses of 50 and 100 mg/kg (p.o.) increased BDNF protein levels by 78.0% and 95.1%, respectively, compared to the control group.
https://www.hindawi.com/journals/mi/2017/6280925/

 

[Chriscom]

What do you mean with biased?

He simply means he works for the institute that has a drug it believes will work. It's like saying you think your team will win the championship--naturally you cheer for your own team! Of course in this case he would add it isn't just belief, there's science and an initial trial that supports that view.

 

[Duderonomy]

The biotech firm that invests (50-110 million dollars) in our research and licenses it - they will make a lot of money.

Yeah, about that. Any idea what the financial cost will be to the sufferer?

 

[Daniel Lion]

Ditto - you guys and ladies are great! Thank you for being so welcoming and civil!

Thank you Justin De Moss.
Thanks again for your time.
We are grateful.