Hough Ear Institute's Hair Cell Regeneration Project

[FGG]

Sorry to go back quite a few pages, but if I gobbled down a handful of Astaxanthin would it have any therapeutic benefit to my synapses?

It has estrogen effects so I wouldn't take handfuls. I have no idea but not sure small amounts would hurt.

 

[mrbrightside614]

These timeframes are ridiculous.

It has been 6 years since phase 1 and when is the phase 2 going to begin?

I'm a cochlear candidate, well let's go already and let's see if it works.

6 years between trials would take a total of, what, 24 years? If I was a drug addict I could go to a rough part of town and get homemade Meth made by the local pharmacist, but I can't pay anybody for a possible hearing drug.

I don't want to hear any excuse for it, it's a broken system, the demand for the drug and profits are clear as day.

I may go to Oblato's front door and ask them what's going on. I have other trials I can be in.

Patients or those who are willing to succumb to trials' demands of poking, prodding, and drugs need to know these timelines to make decisions.

They just got funding. Did you listen to the podcast? Apply for phase 2 if you're a CI candidate.

 

[Lucifer]

Have they stated an actual date on when they will start Phase 2 trials?

 

[Piney]

I've called Oblato, no call back. I see no date or number for trial to apply. I'm also awaiting call back for my 2nd attempt with Frequency Theraputics but the trial site is extremely slow.

This is my point, the Coronavirus shows up and within weeks their begging for trial candidates and 9 companies are working as fast as possible.

I get it, it's a global virus but it just shows how quick things can actually move when they need to. It's frustrating.

 

[Piney]

I called this week too, no reply. I'll get a hold of them eventually, or at least be told we're working on things as quick as we can. I figure them knowing people are interested in trialing isn't a bad thing.

 

[all to gain]

I called this week too, no reply. I'll get a hold of them eventually, or at least be told we're working on things as quick as we can. I figure them knowing people are interested in trialing isn't a bad thing.

Why don't you contact Hough and try to arrange things through them?

 

[Piney]

Maybe I will. I was going by the Tinnitus Talk Podcast that stated Oblato was running it and since they are in NJ I can reach them. I'll call both.

 

[all to gain]

@Justin De Moss

How will the current situation (coronavirus) affect your phase 2 trials?

 

[KyleM]

Maybe I will. I was going by the Tinnitus Talk Podcast that stated Oblato was running it and since they are in NJ I can reach them. I'll call both.

Hello Piney,

What trials have you found in the NJ/NY area? Who is Oblato? They are running trials for Hough Ear Institute?

 

[Piney]

FX-322 trial is in upstate NY, and south of Jersey in Richmond, VA.

Oblato is in Princeton, but the guy never calls back. I really would knock on his door if the coronavirus didn't shut everything down. I called Hough Ear Institute and they take your name down if you want any trial info and/or interest to be in the trial, no date set yet.

 

[El BUZZ]

I've received this e-mail today:

I am reaching out to you on behalf of the entire Hough Ear Institute family to express our concern and gratitude for you during this challenging time.

As you are well aware, COVID-19 is rapidly changing what day to day life looks like for us all. I understand how trying this time can be. Our hope is that all of you are doing what you can to protect yourself, your family, friends, and community. HEI considers you a part of our extended family. Your health and well-being matter to us.

HEI is a research facility that shares a building with two other medical facilities. These organizations are currently still treating those who need it. Because of this shared space, I take our responsibility to help slow the spread of COVID-19 very seriously. Like many other businesses and organizations, we have taken important steps to safeguard our employees and our supporters– These include modified work arrangements, educating our workforce on safety practices, and connecting virtually instead of traveling and meeting face-to-face. We also have postponed fundraising events that put people in close proximity to one another. Each of these decisions will inevitably impact our fundraising, our lifeblood, but we feel these decisions are necessary based on the circumstances to keep everyone safe and healthy.

During this hard time, you and our staff are my number one priority. We are still working tirelessly to find life-changing treatments. To keep this research moving, your support is more crucial than ever. The world around us may slow down, but we know that doesn't mean your suffering stops.

The research toward tinnitus cures and hearing loss health and prevention is still happening. It is easy during times of crisis and uncertainty to pull back on our charitable giving. As we continue providing hope to thousands of patients and families affected by our work, I ask that you consider not pulling back from your regular giving. I humbly ask that you consider giving more– so this research can continue to move forward.

These times may be challenging, but there is still hope. Now, more than ever, we need your help in providing that hope. Your prayers, your encouragement, and your donations are crucial to continuing the advancement of our research.

More information about our mission and links to give online are available at https://houghear.org/supportbreakthroughresearch

I want to thank you from the bottom of my heart for all you do. Thank you on behalf of those suffering from acquired hearing loss and/or tinnitus. Thank you for all you are doing to support your communities as we face this unprecedented moment in our lives.

 

[Piney]

On The Tinnitus Talk Podcast Hough Ear Institute were open about how much funding they needed to push for their research purposes. Is there anyway to track how much more is needed from donations? Or is that impossible unless they input that information on their website?

 

[MrCrybaby]

On The Tinnitus Talk Podcast Hough Ear Institute were open about how much funding they needed to push for their research purposes. Is there anyway to track how much more is needed from donations? Or is that impossible unless they input that information on their website?

They don't only get their money from individuals, they also pursue grants. I believe they were getting a large grant (matched by Oblato) to start their research. Mentioned a few pages back:

They have said they are interested in matching an OCAST grant for $150K for tinnitus. If confirmed, that will be $300K of the $735K needed and we can start the research!

@Justin De Moss if you're around can you confirm if that funding went through?

 

[Jim51042]

It has estrogen effects so I wouldn't take handfuls. I have no idea but not sure small amounts would hurt.

@Tweedleman Nah take handfuls. Just bench a ton to prevent man-boobs.

 

[Justin De Moss]

If I have trouble sometime understanding what someone is saying, is it possible nerve damage in my case and not hair cell damage? My audiogram is normal with slight hearing loss (16 dB).

Sounds like you you might have hidden hearing loss. It could be either. As I understand it the primary cause is believed to be in the nerve ending, however, it can be aggravated by damaged hair cells.

 

[Justin De Moss]

I mean how do you know nerve endings are restored, there have to be some diagnostic tool in place, right?

That sure helps! That's why we are piloting a proof-of-concept study to show pharma companies that there is a model that can objectively test tinnitus. It is one of the major hurdles in getting drugs approved for the indication of tinnitus.

 

[Justin De Moss]

@Justin De Moss

Just wanted to say thanks for all you're doing. You don't need to engage with us, but you do, and that's extremely appreciated.

You are most welcome. We are in this together, at various degrees. I really enjoy your company.

 

[Justin De Moss]

Can somebody give me a clear answer on when this is going to be available? Is it mid 2020? Or mid decade of 2020s?

Mid 2020's not mid 2020, as in 2025/2026 if everything goes as planned.

 

[Justin De Moss]

@Justin De Moss thank you for fighting our side. I'm convinced before I die that I will hear silence or quieter days again. I'm 62, but after 38 years of this I was starting to give up hope. It's just so reassuring that research is being done. There's an awful lot of us with t and more getting it every day. I really don't understand why more funds aren't available for research. Do researchers consider t to be not as important as research into treatments for cancer etc? I'm reaching the end of my treatment for breast cancer, so no doubt research has helped me get to where I am, but t is totally debilitating some days.

Thank you
Ingrid

Thank you! I know plenty of researchers that care about this issue, both here at HEI and elsewhere in the US. I think the main issue you will find is money and influence. The ATA is good but they are limited.

Think about it. Breast cancer kills people. As a result, people who are affected and their loved ones too - all get behind supporting research. The push behind it is so strong that there is essentially a lobby behind it.

The challenge we face is coming together and becoming a financial force. I'm speaking now as a tinnitus sufferer, and someone with mild hearing loss, not as an HEI employee. I used to give to about 5-6 charities with various missions. Now, I only give to faith-based organizations like my church and to hearing loss/tinnitus research. Last year, was the first year we gave more to health research than faith-based organizations.

Until those who suffer can come together financially to help become a "big kid on the block" - it is going to be very scrappy to get the research done. Good thing is that I am very scrappy

 

[Justin De Moss]

Well, ultimately it's all about money. And this applies to all health conditions that are underserved.

Costs a lot to research, and who wants to pay for research when there's no perfect proof. And that goes round and round.

There is a lot of science out there that doesn't make it as far as it could because no one wants to fund something that is hypothetical, even if the science is really really good. History shows it's an incredibly risky investment.

I'm very grateful for the somewhat recent developments in regenerative medicine and my heart goes out to long term sufferers. I've been on this ride 9 months now. I won't even go there - the what ifs.

The one nice aspect about our tinnitus is, it's not rare, and it's increasing. It's odd to say that, but our odds of conquering it are increasing.

Great points. I'm very excited about our research but others as well. That increases the odds that a solution will make it past the goal line.

 

[Justin De Moss]

In this case, I disagree. The DoD pays out $2B+ ANNUALLY in tinnitus-related disability alone, and yet awards one SINGULAR grant (thankfully to HEI) to the tune of 1.9 million over 3 years (unclear if this is the total or 5.7 million). The financial incentive for a cure is there—the problem is with the abovementioned therapy practitioners' conflation of the effects with its causes, thereby obfuscating the core problems of tinnitus and eating up all the grant funding because maybe 4 players in the field have a realistic scientific understanding of its pathology.

I understand your frustration and thoughts here, but one thing to keep in mind is that the government generally only funds initial and early clinical research. The government can help advance more research that was and allow labs to focus on the most promising research results and attract private investment for commercialization. The government take s a broad approach, had they not and applied a standard to what is funded I doubt any hearing loss or tinnitus research would make the cut.

 

[Justin De Moss]

Nobody has a real understanding of the pathology.

We have some educated guesses, but again. You can't identify tinnitus in the body with current diagnostics. Some similarities but no smoking gun.

I will rejoice the day we do get it. Whoever discovers that will, in my opinion, have 75 percent of the battle conquered. From there we can look into genuine repairs, or targeted masking.

That is why we need to show proof to pharma companies that tinnitus can be objectively measured. This will open the flood gates of research into tinnitus treatments specifically!

 

[Justin De Moss]

http://otologicpharma.com/wp-conten..._Effects_of_Delayed_and_Extended_FRR_2011.pdf

Fascinating article examining ANOTHER nitrone compound's (4-OHPBN, not NHPN-1010) effects on acoustic trauma in adjunct therapy (antioxidants NAC + ALCAR).

Another interesting passage about distribution of damage relative to the apex: "Large losses (about 70%) induced by noise were observed at 55–90% distance from the apex, indicating high frequency regions (2–10 kHz). The functional and morphological con- sequences of noise trauma were significantly attenu- ated by a combination of 4-OHPBN plus NAC plus ALCAR."

Thanks for the shout out. Rick is one of the best bosses I've worked for and it is his personal mission that all who have ears, will hear! (If they want to )

 

[Justin De Moss]

Nice catch! He produces absolutely fascinating research. I cannot express enough how thankful I am for people like @Justin De Moss and Dr. Kopke. True innovators and problem-solvers with altruistic motivation. We need more of them in this cold, Luddite-run world.

I think it's interesting they threw ALCAR into the mix considering my prior speculation regarding its potential utility in the hearing regeneration space. I still wouldn't want to rock the boat and dose it concurrently with NHPN-1010 when that fateful day comes, though.

Thank you! We would love to have many more people like those at Hough! It's a great team on a mission collectively to help people!

 

[Justin De Moss]

@Justin De Moss I'll take one magic pill please sir. To go.

I look forward to hopefully seeing more and more news from this topic.

I'd love to give you one! Hopefully in a few years !

 

[Justin De Moss]

Hello, ultimately this drug is not for chronic tinnitus?

It may be helpful for chronic tinnitus too. It appears to be so in animal models - now we just need to come up with a means of objectively measuring tinnitus in humans so we can move forward with a Phase II for the indication if tinnitus, both acute and chronic!

 

[Justin De Moss]

Their upcoming trial will not be for tinnitus. It appears you have to be receiving a cochlear implant to be eligible for the trial, so you might not be eligible regardless of location if you do not have that kind of hearing loss.

Hough are hoping that, once the pill is on the market for use in the cochlear implant population, it can be used "off label" (this is a term for US drugs used for a reason it was not in clinical trials for) for tinnitus. It has not been tested for chronic tinnitus but they believe it will work for acute is chronic. They are trying to raise money for a "proof of concept study" for chronic tinnitus but i believe this will be on rodents (correct me if I have anything wrong, please @Justin De Moss).

We would love to have tinnitus, ototoxicity, and a few other indications tested as well! The proof of concept study will be on animals first, but if it shows promise it can then be used in Phase II clinical study for tinnitus!

 

[Justin De Moss]

I asked Hough about clinical trials in Europe and the answer was negative. They will only test it in USA.

We are seeking approval from the FDA first. Once that is given, then we can work in other markets for approval. I wish this wasn't the case though.

 

[Justin De Moss]

These timeframes are ridiculous.

It has been 6 years since phase 1 and when is the phase 2 going to begin?

I'm a cochlear candidate, well let's go already and let's see if it works.

6 years between trials would take a total of, what, 24 years? If I was a drug addict I could go to a rough part of town and get homemade Meth made by the local pharmacist, but I can't pay anybody for a possible hearing drug.

I don't want to hear any excuse for it, it's a broken system, the demand for the drug and profits are clear as day.

I may go to Oblato's front door and ask them what's going on. I have other trials I can be in.

Patients or those who are willing to succumb to trials' demands of poking, prodding, and drugs need to know these timelines to make decisions.

It doesn't quite work the way you think - thank God! The plan is to have Phase II start this year. That will take 1-2 years. Phase III will start after that. Since Oblato has agreed to take the pill through the remaining (Phase II and III) clinical trials - there shouldn't be the same kind of delay as between Phase I and II - which was based on funding. In other words, the remaining clinical trials have been funded.

The caveat to that is that Oblato is going to seek the indication(s) that are the most promising to get to the market. So Cochlear Implant Trauma is one of those, ototoxicity is another one. Tinnitus might be if we can get this proof of concept study going. They are interested in it for sure!

 

[Justin De Moss]

I've called Oblato, no call back. I see no date or number for trial to apply. I'm also awaiting call back for my 2nd attempt with Frequency Theraputics but the trial site is extremely slow.

This is my point, the Coronavirus shows up and within weeks their begging for trial candidates and 9 companies are working as fast as possible.

I get it, it's a global virus but it just shows how quick things can actually move when they need to. It's frustrating.

I understand the frustration but we are talking about the difference between a life-threatening infectious virus that has swept the entire globe versus tinnitus. I don't try to discredit our sufferings, but it is understandable that these things would get fast-tracked. Plus, as I understand it, researching virus, treatments, and vaccines is a lot simpler than most other pharmacological research, especially our at HEI.

I agree it is frustrating. With all the lockdowns, people are getting a glimpse into our lives that we live and have lived for years. Hopefully, this will create some empathy and maybe some changes in the way we get drugs approved!