Audion Therapeutics Trial

[Manny]

I don't think GenVec/Novartis trial isn't even something that will make it to market.
it's just one of those lets see what happens trials.
https://clinicaltrials.gov/ct2/show/NCT02132130

Genvec's product is going nowhere. At this point they are just trying to salvage something or continuing simply for research purposes.

What makes you guys say that?

 

[Coleoptere]

@parsky you can find details here: www.actiononhearingloss.org.uk/live-well/our-community/our-blog/regain-update-an-opportunity-for-people-with-hearing-loss-to-take-part-in-a-clinical-trial/

 

[Coleoptere]

If you check the link and scroll down you will find:

"The results of the phase I and II REGAIN studies will be published after the completion and data analysis of both studies; we are aiming for early 2020.".

 

[Olive27]

They are now recruiting for phase 2 trials. They have emailed me and asked for a telephone interview to see if I would be eligible. Will probably do interview etc to see I can get more information but I doubt I'd actual do trial if accepted

 

[Contrast]

They are now recruiting for phase 2 trials. They have emailed me and asked for a telephone interview to see if I would be eligible. Will probably do interview etc to see I can get more information but I doubt I'd actual do trial if accepted

why wouldn't you?

 

[Olive27]

I'd be scared of it failing and losing more hearing which I really really don't want!

 

[Contrast]

I'd be scared of it failing and losing more hearing which I really really don't want!

is that a real risk?


I don't see how you can lose hearing?

 

[JohnAdams]

is that a real risk?


I don't see how you can lose hearing?

If the substance is improperly stored or handled and an infection sets up. I think that's unlikely but still possibly a risk, one I'd gladly take

 

[Olive27]

Having hearing loss is worse than tinnitus.....I have both and had tinnitus before my hearing dropped to the current low levels

 

[Benoves]

Having hearing loss is worse than tinnitus.....I have both and had tinnitus before my hearing dropped to the current low levels

That's not always the case. I was totally completely fully habituated to my 40 dB hearing loss for 25 years until I got tinnitus and it got me suicidal for a very long time. I didn't even wear hearing aids for 25 years.

 

[Johan_L]

I'd be scared of it failing and losing more hearing which I really really don't want!

Everything we do in life is a calculated risk, even just leaving our homes. I've realized that I have a much higher risk of getting into an car accident as my earmuffs reduce my hearing... (I have H)

If there was a drug with 50% chance of getting better and say 2% risk of infection/getting worse I'd take it any day.

 

[Krolo]

Hopefully someone on TT who lives in the UK can get into this trial. Since it's only open to UK citizens.

 

[Fabrikat]

The Audion Regain trial promises efficacy results from Phase II in early 2020.

If it proves successful (always IF) and 2020 into 2021 is the Phase III period, I'm wondering if anyone knows what the process is in Europe to bring a treatment to the clinic.

Is it the same as the US FDA's? Is it as longwinded and bureaucratic? Or do the Europeans do things a little differently?

 

[Pero1234]

Or do the Europeans do things a little differently?

We do things differently in Europe.

Look up the timeline so far for this thing called Brexit.

After millions and millions... valid arguments on both sides... we will probably never come to an agreement... so we'll probably abandon the thing altogether. Or remain in limbo indefinitely.

I sincerely hope this will not be the case for Audion. But I have more confidence in FX. When there's money to be earned, you can always count on the US. Which is a good thing here.

On a more serious note, I am not familiar with the procedures here. I will send our Belgian minister of health a mail tomorrow to find out.

 

[Fabrikat]

I will send our Belgian minister of health a mail tomorrow to find out.

Actually, wasn't it your Prime Minister that suffered a hearing injury as result of some kind of noise accident? I recall seeing news footage, perhaps even posted here on TT a couple of years ago.

One would think he would now be personally invested in ensuring Audion moves as fast as possible to market. At least in Belgium anyway!

 

[Fabrikat]

Indeed @Pero1234, it was your Prime Minister who suffered hearing loss and tinnitus courtesy of a starters gun. There is a thread here on TT devoted to the incident.

http://www.telegraph.co.uk/news/201...rs-hearing-loss-princess-astrid-starting-gun/

 

[Paulmanlike]

The Audion Regain trial promises efficacy results from Phase II in early 2020.

If it proves successful (always IF) and 2020 into 2021 is the Phase III period, I'm wondering if anyone knows what the process is in Europe to bring a treatment to the clinic.

Is it the same as the US FDA's? Is it as longwinded and bureaucratic? Or do the Europeans do things a little differently?

You got a link?

 

[Fabrikat]

You got a link?

It's on the Action On Hearing Loss Audion Regain research update page and comments sections.

https://www.actiononhearingloss.org...earing-loss-to-take-part-in-a-clinical-trial/

 

[Fabrikat]

As a Brit @Paulmanlike, you have the opportunity to participate in the Audion trial if you wish. They're keen for numbers.

 

[Pero1234]

Actually, wasn't it your Prime Minister that suffered a hearing injury as result of some kind of noise accident? I recall seeing news footage, perhaps even posted here on TT a couple of years ago.

One would think he would now be personally invested in ensuring Audion moves as fast as possible to market. At least in Belgium anyway!

Yes, he went to the same hospital / hyperbaric oxygen chamber as me. University hospital of Antwerp.

 

[Fabrikat]

Yes, he went to the same hospital / hyperbaric oxygen chamber as me. University hospital of Antwerp.

And was it helpful?

 

[Paulmanlike]

As a Brit @Paulmanlike, you have the opportunity to participate in the Audion trial if you wish. They're keen for numbers.

Just checked it out, thanks. I had a 30 dB loss in 6 kHz range but I will get retested next week to confirm it. Interesting in the comments they will be looking at any effect on tinnitus as well.

 

[Paulmanlike]

As a Brit @Paulmanlike, you have the opportunity to participate in the Audion trial if you wish. They're keen for numbers.

Jeez this whole hearing regeneration is movingly faster than expected. I hope they will also publish the results if it cures tinnitus as well, and it's safe, then it's just a waiting game. I suppose until then, we have Neuromod working on bimodal neuromodulation to keep the noise down whilst this thing comes out. I expect if it's successful to be on the market no later than 2023.

Click laughing face if you're reading this in 2023 and they still haven't figured it out.

 

[Pero1234]

And was it helpful?

I don't know... I don't hang out with the guy

 

[Fabrikat]

I don't know... I don't hang out with the guy

No, I meant you!

 

[Fabrikat]

Jeez this whole hearing regeneration is movingly faster than expected. I hope they will also publish the results if it cures tinnitus as well,

I must say that I really like Action On Hearing Loss as an organisation too. They seem to have their fingers in so many pies.

They're not just about counselling, rehabilitation and publicity, but they also fund seminal and ongoing research into treatments and cures for hearing loss and tinnitus all over the globe. I'm not sure if they've received much attention on TT (perhaps they have over the years), but they seem to be the type of organisation that many people on TT wish the BTA and the ATA were. Admittedly, they're of longer standing and maybe better funding. They appear very worthy of our support.

 

[Pero1234]

No, I meant you!

I got my first HBOT three weeks after the noise induced trauma and because the meds did not resolve my T completely.

Five weeks after HBOT my mild tone was reduced to a static hiss which I only heard in silent surroundings. The weeks after the sessions my ears were itching deep inside, like a wound that's recovering... I cannot tell whether it was HBOT or my own body healing...

I personally do believe it can help your body heal, but only in the first few weeks.

Unfortunately, my T increased again after two incidents:

1) high pressure cleaning with lousy earplugs

2) one pill of trazodone which made me freak out and which "moved" my static ear-tinnitus to a sharper head tinnitus.

 

[d'Wooluf]

Positive results from phase 1 (nothing about efficacy):

http://www.pharmabiz.com/NewsDetails.aspx?aid=114010&sid=2

 

[Fabrikat]

Positive results from phase 1 (nothing about efficacy):

Audion is running at the same pace as Frequency. If they're successful, here's hoping perhaps they could hit the market first. Certainly in Europe without all the FDA red tape.

 

[Striveon]

Audion is running at the same pace as Frequency. If they're successful, here's hoping perhaps they could hit the market first. Certainly in Europe without all the FDA red tape.

Will this help cure chronic tinnitus?