Inner Ear Hair Cell Regeneration — Maybe We Can Know More

http://newsok.com/article/5560970

This article came across my news feed. Don't see it posted yet, although the trial has been discussed below.
Nice find!

Quoting:
"In the military, blast injuries, which produce ringing in the ear and sound when there is nothing producing sound, are very common. It was a serendipitous discovery that as we were testing the pill as a therapy to prevent hearing damage, we discovered that it actually regrew the nerve endings that connect the inner ear to the brain, restoring hearing."
It looks awesome, doesn't it? :)
 
It does if you take the pill shortly after an acoustic trauma - it doesn't say for those who have had nihl for many years. However this was found on their website.

OPI and its collaborating institutions Hough Ear Institute and Oklahoma Medical Research Foundation will evaluate the potential utility of NHPN-1010 to treat tinnitus, vestibular injury and traumatic brain injury associated hearing disorders. approaches that are currently in early stages of research.
 
It looks awesome, doesn't it? :)
Almost to good to be true.

"that could prevent hearing loss and regenerate the nerve endings inside the ear to restore hearing to people whose hearing has already declined."
Has already declined for how long?
"The common culprits are everywhere: earbuds, loud music, concerts and TV, leaf blowers and lawn mowers, construction noise, and, for those in the military, explosions."
Who turns up the volume of his TV set up so loud it gives you hearing loss?
I suppose I am a dinosaur with my old tube TV set, which by the way you can also find in a museum (-;

This news from Hough Ear Institute is the high light of my day. I do hope more positive news follows.
 
It looks awesome, doesn't it? :)
It does, but they hardly disclose anything about this drug or where they are heading with it!

What I can gather is that they target the nerve synapses, right? Not the HC themselves?
And this is taken orally? Must be some kind of neurotrophic growth-factors then? NT-3?
This sounds, maybe to good to be true. And they have already tried it on people?, without pre- clinical trials?
Clinical trials will come after they saw this effect in humans?

Why is suddenly almost everything turned on its head here, as opposed to the time-consuming process we hear of time and time again? clinical -testing-testing-testing, approval-approval-approval, 3 years, 5 years, 10 years. Maybe fast track this and that:banghead::banghead::banghead::banghead:

They have a pill that by "serendipitous discovery" restore inner ear synapses? They found out by chance? And the waiting game begins?
I WANT IT NOW!
 
Time they start a clinical trial!
Interesting you should say that.
I checked the Otologic Pharmaceutics website.
http://otologicpharmaceutics.com/the-science/
Quote: "Proceeds of the Series A financing will be used to advance the development of OPI's lead product candidate, NHPN-1010, for the treatment of noise-induced hearing loss (NIHL), which is expected to enter Phase 1 clinical testing in the first half of 2014."
Apparently the website is not updated if this NHPN-1010 is the "pill" Hough Ear is talking about.
 
The article is from this week, So this seems pretty recent to me. Maybe they do not want to do a press release until they have an actual product to put out
 
OPIs primary focus is to advance the clinical development of our lead product NHPN=1010 which is a combination of two well-understood and safe compounds; HPN-07 and NAC.

The target indication will be as an otoprotectant to prevent and treat acute hearing loss and by doing so prevent development permanent hearing disorders. The technology enables enhanced recovery from ototoxic or traumatic injury and hence reduces permanent hearing loss when given before or shortly after acute injury.

Our lead indication is treatment of acute noise induced hearing loss (NIHL), a program that has received extensive funding from the US Department of Defense. NHPN-1010 will enter clinical trials in 2014 to advance the NIHL indication.

Also in 2014 OPI will initiate IND enabling studies to support clinical evaluation of NHPN-1010 treatment to prevent or reverse acute Cisplatin induced hearing loss (CIHL). Cisplatin is a widely used anti-cancer treatment used in adults and children. Cisplatin causes marked hearing loss in over 75% of the nearly 700,000 patients treated each year

OPI and its collaborating institutions Hough Ear Institute and Oklahoma Medical Research Foundation will evaluate the potential utility of NHPN-1010 to treat tinnitus, vestibular injury and traumatic brain injury associated hearing disorders. approaches that are currently in early stages of research.

Taken from their website if the pill is given shortly after AT then it will speed up the recovery process - nowhere does it mention fixbig already long term hearing damage.
 
It is not clear to me if they concentrate on regenerating hair-cells or regenerating the connections to hair cells.

According to the article with that drug they weren't "focused" on either outcome they were trying to preserve existing hair cells from addition damage. But they noticed a cool side effect from the drug was regenerating some nerve fibers aka connections to the hair cells.
 
Acoustic injury can result in the initiation of inflammatory and cell death pathways that remain active for days to weeks and the ensuing permanent neural and hair cell injury can play out over a period of days or weeks. Therefore, a short therapeutic window exists post-injury where an antioxidant, anti-inflammatory or antiapoptotic treatment can enhance recovery and reduce permanent hearing loss. Accordingly, a great deal of research has been dedicated to discover antioxidant compounds that can neutralize ROS with the aim of preventing and/or treating damage to the cochlea

--
talking about a therapeutic window - that's us lot out
 
According to the article with that drug they weren't "focused" on either outcome they were trying to preserve existing hair cells from addition damage. But they noticed a cool side effect from the drug was regenerating some nerve fibers aka connections to the hair cells.
Yeah, that's what I believe, too. Hope we'll eventually get a proper paper or at least more information. Someone should try to email them.
 
OPIs primary focus is to advance the clinical development of our lead product NHPN=1010 which is a combination of two well-understood and safe compounds; HPN-07 and NAC.

The target indication will be as an otoprotectant to prevent and treat acute hearing loss and by doing so prevent development permanent hearing disorders. The technology enables enhanced recovery from ototoxic or traumatic injury and hence reduces permanent hearing loss when given before or shortly after acute injury.

Our lead indication is treatment of acute noise induced hearing loss (NIHL), a program that has received extensive funding from the US Department of Defense. NHPN-1010 will enter clinical trials in 2014 to advance the NIHL indication.

Also in 2014 OPI will initiate IND enabling studies to support clinical evaluation of NHPN-1010 treatment to prevent or reverse acute Cisplatin induced hearing loss (CIHL). Cisplatin is a widely used anti-cancer treatment used in adults and children. Cisplatin causes marked hearing loss in over 75% of the nearly 700,000 patients treated each year

OPI and its collaborating institutions Hough Ear Institute and Oklahoma Medical Research Foundation will evaluate the potential utility of NHPN-1010 to treat tinnitus, vestibular injury and traumatic brain injury associated hearing disorders. approaches that are currently in early stages of research.

Taken from their website if the pill is given shortly after AT then it will speed up the recovery process - nowhere does it mention fixbig already long term hearing damage.

Acoustic injury can result in the initiation of inflammatory and cell death pathways that remain active for days to weeks and the ensuing permanent neural and hair cell injury can play out over a period of days or weeks. Therefore, a short therapeutic window exists post-injury where an antioxidant, anti-inflammatory or antiapoptotic treatment can enhance recovery and reduce permanent hearing loss. Accordingly, a great deal of research has been dedicated to discover antioxidant compounds that can neutralize ROS with the aim of preventing and/or treating damage to the cochlea

--
talking about a therapeutic window - that's us lot out
You're quoting a website that hasn't been updated for 3-4 years. Meanwhile, a lot of things may have changed (and indeed have changed according to the press report).
 
The key prefix in all of those word is anti. Growing nerve synapses is not anti. With nerve regrowth this drug would likely not have a "window". Regrow our ear nerves I'm in. Lets all starting taking this drug and over time rid ourselves of T!!!

Need to get in touch with them, one of their evaluations in the future is how this impacts T

You're quoting a website that hasn't been updated in 3-4 years. Meanwhile, a lot of things may have changed (and indeed have changed according to the press report).

I just don't want to get hopes up for something that may not be as great as it sounds at least for us

Alledgedly they started phase 1 trails in 2014 but where are they now? Seem pretty elusive
 
I will start by saying that I hope I am wrong, but ...

I've followed Hough for a few years now, and if you believe their web site, they have been on the verge of curing hearing loss for years. They just need a few hundred thousand dollars because their federal funding has fallen by 85%. Seems likely that if they could demonstrate that they were on the verge of a major breakthrough, their funding would not have fallen that much. Research funding in the US has fallen generally, but other labs working on similar ideas have not seen drops like that. Additionally, Otologic attracted $4 million with the start of their trial. Since then, there is no evidence of additional funding, but Decibel and Frequency have attracted something like 80 million dollars. (I've written more about Hough elsewhere which a search would surely find.)

The trial alluded to above was a Phase I trial that was completed in 2015 (https://clinicaltrials.gov/ct2/show/NCT02259595), but there hasn't been an announcement of a Phase II study in the last 2 1/2 years or any publications on the safety of the drug (NAC + HPN-07). They are, however, continuing to do animal studies: https://www.ncbi.nlm.nih.gov/pubmed/28438658

I've contacted them in the past asking about new papers or evidence of their claims, and they have not responded. Hopefully they are where they say they are, but in the absence of significant publications their "announcements" sound like fundraising pitches to me.
 
I will start by saying that I hope I am wrong, but ...

I've followed Hough for a few years now, and if you believe their web site, they have been on the verge of curing hearing loss for years. They just need a few hundred thousand dollars because their federal funding has fallen by 85%. Seems likely that if they could demonstrate that they were on the verge of a major breakthrough, their funding would not have fallen that much. Research funding in the US has fallen generally, but other labs working on similar ideas have not seen drops like that. Additionally, Otologic attracted $4 million with the start of their trial. Since then, there is no evidence of additional funding, but Decibel and Frequency have attracted something like 80 million dollars. (I've written more about Hough elsewhere which a search would surely find.)

The trial alluded to above was a Phase I trial that was completed in 2015 (https://clinicaltrials.gov/ct2/show/NCT02259595), but there hasn't been an announcement of a Phase II study in the last 2 1/2 years or any publications on the safety of the drug (NAC + HPN-07). They are, however, continuing to do animal studies: https://www.ncbi.nlm.nih.gov/pubmed/28438658

I've contacted them in the past asking about new papers or evidence of their claims, and they have not responded. Hopefully they are where they say they are, but in the absence of significant publications their "announcements" sound like fundraising pitches to me.
Unfortunately I agree with Aaron.

What's your view on the best company to watch Aaron? Do you believe they will cure tinnitus with regeneration/synapse repair? How long do you think something will be on the market?

I'm asking you specifically because you are like a God-of-knowledge on this website. I would appreciate your personal opinion.

....and you're good at telling people off for going off topic..
 
I will start by saying that I hope I am wrong, but ...

I've followed Hough for a few years now, and if you believe their web site, they have been on the verge of curing hearing loss for years. They just need a few hundred thousand dollars because their federal funding has fallen by 85%. Seems likely that if they could demonstrate that they were on the verge of a major breakthrough, their funding would not have fallen that much. Research funding in the US has fallen generally, but other labs working on similar ideas have not seen drops like that. Additionally, Otologic attracted $4 million with the start of their trial. Since then, there is no evidence of additional funding, but Decibel and Frequency have attracted something like 80 million dollars. (I've written more about Hough elsewhere which a search would surely find.)

The trial alluded to above was a Phase I trial that was completed in 2015 (https://clinicaltrials.gov/ct2/show/NCT02259595), but there hasn't been an announcement of a Phase II study in the last 2 1/2 years or any publications on the safety of the drug (NAC + HPN-07). They are, however, continuing to do animal studies: https://www.ncbi.nlm.nih.gov/pubmed/28438658

I've contacted them in the past asking about new papers or evidence of their claims, and they have not responded. Hopefully they are where they say they are, but in the absence of significant publications their "announcements" sound like fundraising pitches to me.
I am agreed with Aaron as well. I have also been following them for years and someone is always able to pick apart their claims. You go to their website and its numerous pitches for fundraising. I wouldn't get too hopeful on this one.
 
Not about inner ear regeneration per se, but an interesting article about the nerve synapses
https://theconversation.com/some-nerves-how-loud-noise-may-change-hearing-71304

Interesting, Maybe this is what Josef is talking about in about using serotonin and dopamine as potential treatments for tinnitus.

https://www.sciencealert.com/scient...the-answer-to-what-causes-ringing-in-the-ears

Here they also talk about the gate keeping being compromising thus leading to tinnitus.
 
What strike me is that the compounds used to regenerate these cells so far are largely safe. For those who know, it's mostly anti tgfb1, wnt activator, hdac inhibitor and the like.

For god sake it is safe, so why waiting this long :frustration:
 

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