Hough Ear Institute's Hair Cell Regeneration Project

[DimLeb]

I believe that since it passed the safety trial, one has nothing to lose by trying the pill out.

Unfortunately for us here in Europe, I don't see how we could apply for it.

 

[InNeedOfHelp]

EMA/Europe also has a Compassionate use program.

https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use

You could try there.

 

[Gb3]

So was that article true? And Justin had no idea what he was talking about.

 

[scotty03874]

So Ashley is from where though?

From Hough Ear Institute.

 

[scotty03874]

Does anyone know if I can apply for compassionate use? I live in Spain.

Only the USA right now for compassionate use.

 

[scotty03874]

I think Ashley is the new @Justin De Moss - aka Philanthropy Director for Hough Ear Institute. Are we all applying for this or what? Or is this only for acute NIHL?

Yes, her signature line said Philanthropy Director.

 

[scotty03874]

Wow!!! OK, who is going to be the brave soul to give this a go?

I will 100% if I get approved...

 

[Rb86]

So was that article true? And Justin had no idea what he was talking about.

Justin was talking about how and why Hough Ear Institute acquired this drug candidate. I'd say a guy who was an employee of Hough Ear Institute knows a little more than you. But please do prove him wrong.

 

[Gb3]

Justin was talking about how and why Hough Ear Institute acquired this drug candidate. I'd say a guy who was an employee of Hough Ear Institute knows a little more than you. But please do prove him wrong.

He told us it wasn't available for compassionate use. It looks like it is according to the above post?

 

[IntotheBlue03]

Not sure if I'm going to go through with it but I'm going to ask my PCP about applying for this. He prescribed me Topamax which I refused to take right off the bat so what's the harm in an off label investigatory anti-seizure med?

 

[Gee82]

To all my European fellows: I wrote an email to the FDA enquiring if non-US residents would be eligible to the expanded access. Here's their reply:

"Typically, if a patient is not an United States citizen, then approval would be needed from the regulatory agency governing their own respective country. In addition, the treating physician would also need to obtain agreement from the drug company who would be providing the drug for the patient's use."​

It sounds to me that we can still apply, but we probably have to check in with EMA first. I will try to contact them to see if they can help.

 

[Brian Newman]

I will be going to doctors to find one who will write a good summary of my case. I will keep everybody updated. Definitely need something to reconnect my nerves.

 

[AnonymousPie]

I was emailing with a lady from Hough Ear Institute who got back to me and said it will be aimed at basically all types of tinnitus, regardless of the cause, with or without hearing loss.

So sorry for my delayed response. It's been a busy week so far!

In regards to the pill, our licensing partner, Oblato, Inc., is in charge of where we seek clinical approval for NHPN-1010 and currently their focus is the FDA. Unfortunately, we're just the inventors of the pill, they're the ones responsible for getting it to the market. As such, we have no control over that part of the process so I can't tell you whether or not they will seek clinical approval in Europe, too.

And yes, our formulation is designed to treat tinnitus of all kinds. It's also worthy to mention that tinnitus is actually a type of nerve-deafness which has nothing to do with the ear drum. That means no worries for you there!

I hope that answers your questions! Let me know if you have any more.

ASHLEY EVERETT

Philanthropy Coordinator

 

[Joeseph Stope]

I will be going to doctors to find one who will write a good summary of my case. I will keep everybody updated. Definitely need something to reconnect my nerves.

Not one to pee on your parade or on your placebo-effect (which can have significant influence on outcome) but don't set your heart and soul on it.

But prove me wrong. I'll be very happy.

 

[Brian Newman]

Not one to pee on your parade or on your placebo-effect (which can have significant influence on outcome) but don't set your heart and soul on it.

But prove me wrong. I'll be very happy.

Not expecting a miracle but it's worth a try. I need relief or I will not be around much longer. Anything that has potential regenerative effects even in mice needs to be tried before I do anything drastic. I must try all drugs or see if any of the drugs in the pipeline go to Phase 3. If I don't think there's a chance after the results this year, I will be starting surgery after surgery, I will remove my inner ear if I have to. This level of noxacusis is not livable.

 

[AnonymousPie]

Another email from Ashley from Hough Ear Institute with regards to hyperacusis. Just asked her about inner ear damage, cochlear hydrops and Meniere's disease. Fingers crossed we get things for all types of damage or tinnitus and other conditions soon.

Our hearing loss pill is used to treat noise-induced traumas/degeneration so it's possible, BUT (and this is a big but) we haven't studied the pill's efficacy for that specific disorder. It is believed the same neural pathways that cause tinnitus are the same that cause hyperacusis which is why I say it's possible, but again, research is needed to know for sure. As far as acoustic trauma, yes. The pill would aid in treating hearing loss and tinnitus induced by those traumas. And the patient receiving NHPN-1010 currently through the FDA's expanded access program has had tinnitus for many years.

Hope that answers your questions! Let me know if you have any more. Have a blessed weekend!

ASHLEY EVERETT
Philanthropy Coordinator

 

[prowlinacage]

Is it me or does it seem like HEI's Philanthropy Coordinator is getting a little over her skis here?

 

[Bambam0]

Who all have actually applied for compassionate use so far? If someone does, will they outline the process they used?

 

[Mentos]

Is it me or does it seem like HEI's Philanthropy Coordinator is getting a little over her skis here?

She allows herself more than Justin De Moss did for sure, seems to me more honest and opened than her predecessor though. At least she does not end each of her email asking for donations.

 

[Bambam0]

At least she does not end each of her email asking for donations.

They'd sure raise more $$ if people knew it worked!

 

[Diesel]

Is it me or does it seem like HEI's Philanthropy Coordinator is getting a little over her skis here?

This community is also relentless about bothering public-facing people of these hearing loss treatment organizations. She's new. She'll get burned. She'll learn.

 

[Brian Newman]

Another email from Ashley from Hough Ear Institute with regards to hyperacusis. Just asked her about inner ear damage, cochlear hydrops and Meniere's disease. Fingers crossed we get things for all types of damage or tinnitus and other conditions soon.

Did you ask what the patient receiving the drug had to do to obtain compassionate use? I mean to get approved for it?

 

[IntotheBlue03]

Can anyone clarify if the compassionate use tinnitus sufferer was in the initial trial? Or if there's been any follow up on them?

 

[Brian Newman]

Another email from Ashley from Hough Ear Institute with regards to hyperacusis. Just asked her about inner ear damage, cochlear hydrops and Meniere's disease. Fingers crossed we get things for all types of damage or tinnitus and other conditions soon.

What's the email address you contacted her by?

 

[AnonymousPie]

Did you ask what the patient receiving the drug had to do to obtain compassionate use? I mean to get approved for it?

Hey Brian! The email I have for her is info@Houghear.org and her name is Ashley Everett. Try searching Google her name to see if anything comes up. She said she believes this will help all types of hearing loss & tinnitus including auditory neuropathies etc but I suppose we just gotta wait and see. They're waiting to do trials she said. I think if all these companies could already just start the human clinical trials, we'd get this ball rolling very soon.

 

[Brian Newman]

Hey Brian! The email I have for her is info@Houghear.org and her name is Ashley Everett. Try searching Google her name to see if anything comes up. She said she believes this will help all types of hearing loss & tinnitus including auditory neuropathies etc but I suppose we just gotta wait and see. They're waiting to do trials she said. I think if all these companies could already just start the human clinical trials, we'd get this ball rolling very soon.

Thanks! I am trying to apply for compassionate use, so I want to talk to her and get her advice on it. I will be having my doctor apply pretty soon. Gotta go in and explain this drug to him.

Yeah I wish they would hurry up, at least the other drugs have Phase 2 results coming out this year. So we will see. This is a big year.

I think I would be an excellent test candidate for this drug anyways. Fingers crossed.

 

[IntotheBlue03]

I know it's anecdotal but I wish we knew more about the tinnitus patient on compassionate use and if the pill is still effective and/or how effective it is.

 

[Gb3]

I know it's anecdotal but I wish we knew more about the tinnitus patient on compassionate use and if the pill is still effective and/or how effective it is.

Dr. Santosh Kesari of the Saint John's Cancer Institute.

 

[IntotheBlue03]

Dr. Santosh Kesari of the Saint John's Cancer Institute.

Thanks @Gb3. Can you elaborate? Is that the doctor who signed on for the compassionate use application of the tinnitus patient?

 

[Gb3]

Dr. Santosh Kesari of the Saint John's Cancer Institute.

Is that the doctor who signed on for the compassionate use application of the tinnitus patient?

@IntotheBlue03, I believe so...

FDA OKs expanded access program for HLB Therapeutics' tinnitus treatment candidate