Hough Ear Institute's Hair Cell Regeneration Project

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

 

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.

 

Yes, there are.

 

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

 

I'm sure it'll heal.

 

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

 

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.

 

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!

 

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!

 

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.

 

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.

 

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

 

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.

 

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

 

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.

 

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

 

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.

 

It's not the FDA, it is funding.

 

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

 

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.

 

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!

 

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!

 

I do. But I'm biased

 

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.

 

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

 

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/

 

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.

 

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

 

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