Frequency Therapeutics — Hearing Loss Regeneration

[Bartoli]

What's interesting is they didn't get to that part of the interview before i was disqualified. I might have been disqualified based on that but my audiogram disqualified me first.

What you may call mild hearing loss at a normal audiogram may not be their definition? The common definition is something like 20 or 25 dB at 3 pure tones.

 

[FGG]

What you may call mild hearing loss at a normal audiogram may not be their definition? The common definition is something like 20 or 25 dB at 3 pure tones.

Right. I don't know their definition and it was not shared with me.

 

[Hammers]

Call me stupid but wouldn't we need to regenerate the auditory nerve before we regenerate hair cells, at least in the case of people who have had hearing loss for more than a year?

 

[JohnAdams]

Call me stupid but wouldn't we need to regenerate the auditory nerve before we regenerate hair cells, at least in the case of people who have had hearing loss for more than a year?

Dr. Robert Jackler, over Heller Lab at Stanford University, where they discovered hair cell regeneration, stated in a presentation that once the hair cell regrows that the auditory nerve regrows and reconnects to the new hair cell. He even called it a "miracle".

 

[RingingBrother]

Do you get paid for being in the FX-322 trial? Does anyone know the amount?

 

[JohnAdams]

Do you get paid for being in the FX-322 trial? Does anyone know the amount?

$322.

 

[JohnAdams]

I think the two ingredients are this:
https://www.tocris.com/products/chir-99021_4423
and this:
https://www.tocris.com/products/valproic-acid-sodium-salt_2815

They have passed 2 safety trials.

Can we please try this out now?

 

[Caveman]

I think the two ingredients are this:
https://www.tocris.com/products/chir-99021_4423
and this:
https://www.tocris.com/products/valproic-acid-sodium-salt_2815

They have passed 2 safety trials.

Can we please try this out now?

I can't believe how excruciatingly slow the approval process is!!!

 

[Flyingsheep]

I think the two ingredients are this:
https://www.tocris.com/products/chir-99021_4423
and this:
https://www.tocris.com/products/valproic-acid-sodium-salt_2815

They have passed 2 safety trials.

Can we please try this out now?

How on earth did you find that? What??

 

[JohnAdams]

How on earth did you find that? What??

It's out there man.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395286/

 

[JohnAdams]

I can't believe how excruciatingly slow the approval process is!!!

They are actually moving pretty fast considering how recently they discovered all of this stuff.

 

[JohnAdams]

Notice anything in that study by the Frequency Therapeutics people?

IGF-1.

IGF-1 is in PRP.

 

[Piney]

They pay you a 75 dollar check, I believe each time you go. I only went once so that's all I got.

 

[Mathieulh]

They pay you a 75 dollar check, I believe each time you go. I only went once so that's all I got.

Do you know if you received placebo? How did it go? Can you talk about it?

 

[FGG]

Do you know if you received placebo? How did it go? Can you talk about it?

The $75 was also for the eval visit. I got the same check.

 

[John Queen]

Those of you who are Americans, couldn't you petition to the FDA and engage the Hearing Loss / Tinnitus associations to find a way to include drugs like FX-322 in the expanded access program?

It's plain stupid what the FDA does right now, FX-322 actually completed 2 studies (Phase 1 & Phase 1/2) which included SAFETY, yet we can't request to try the drug. It's--plain--stupid.

There's nothing that they should keep us away from. If we do nothing, they will just go on with the usual long, dull drug approval process; maybe, just maybe we can do something about it.

 

[FGG]

Those of you who are Americans, couldn't you petition to the FDA and engage the Hearing Loss / Tinnitus associations to find a way to include drugs like FX-322 in the expanded access program?

It's plain stupid what the FDA does right now, FX-322 actually completed 2 studies (Phase 1 & Phase 1/2) which included SAFETY, yet we can't request to try the drug. It's--plain--stupid.

There's nothing that they should keep us away from. If we do nothing, they will just go on with the usual long, dull drug approval process; maybe, just maybe we can do something about it.

Frequency says on their website they are not equipped to handle the demand for expanded use atm.

 

[JohnAdams]

Frequency says on their website they are not equipped to handle the demand for expanded use atm.

I can see that.

 

[neo-t]

I haven't kept up with Frequency Therapeutics. Are they measuring tinnitus now? I saw something on their clinical trial page about tinnitus but i didn't understand it much.

 

[Pero1234]

It's plain stupid what the FDA does right now, FX-322 actually completed 2 studies (Phase 1 & Phase 1/2) which included SAFETY, yet we can't request to try the drug. It's--plain--stupid.

There's nothing that they should keep us away from. If we do nothing, they will just go on with the usual long, dull drug approval process; maybe, just maybe we can do something about it.

Don't forget that they have no idea yet how much of their medicine they should pour in your ear to be most effective. They're figuring this out at this very moment.

It would be nice to know at least that beforehand, I guess.

 

[John Queen]

Don't forget that they have no idea yet how much of their medicine they should pour in your ear to be most effective. They're figuring this out at this very moment.

It would be nice to know at least that beforehand, I guess.

No problem, I'd be happy to try the dose used in the Phase 1/2 study, which is likely safe; I don't necessarily need good efficacy.

Frequency says on their website they are not equipped to handle the demand for expanded use atm.

Now I see... I honestly hope that'll change after this clinical trial. Even if they'd ask for a higher price for the drug to cover all the expenses, I wouldn't care...

I haven't kept up with Frequency Therapeutics. Are they measuring tinnitus now? I saw something on their clinical trial page about tinnitus but i didn't understand it much.

Yeah, they're also assessing tinnitus in this trial as a secondary outcome measure.

 

[d'Wooluf]

Some people might find this article interesting and 'on point', seeing as Frequency Therapeutics is partnering with a Japanese company:

https://hbr.org/sponsored/2018/02/h...ities-in-the-field-of-regenerative-medicine-2

 

[serendipity1996]

Some people might find this article interesting and 'on point', seeing as Frequency Therapeutics is partnering with a Japanese company:

https://hbr.org/sponsored/2018/02/h...ities-in-the-field-of-regenerative-medicine-2

Great find and makes me hopeful for the future!

 

[LostOutWest]

Perhaps it is discussed somewhere in the thread, but I wonder if this drug will work for people that have tinnitus and healthy audiograms that do not show hearing loss? Sure there could be hidden hearing loss but because this isn't being tested for tinnitus without apparent HL, I'm not sure what it does for some of us.

@JohnAdams I believe you have pretty healthy audiograms and you're bullish on FX322 - what are your thoughts?

 

[JohnAdams]

I wonder if this drug will work for people that have tinnitus and healthy audiograms that do not show hearing loss?

They have only been accepting those with a good amount of hearing loss for their trials so there is no data for that.

I think there is a good chance it will.

 

[RingingBrother]

That's an interesting question that I've thought about myself. Some deafness at birth is the result of genetics, though I haven't looked into the specific mechanisms. I would guess that if a person simply doesn't have progenitor cells in their cochlea then FX-322 won't do anything for them. If the deafness has some other cause not related to genetics then maybe it could work.

I wonder if there are any drugs in the works that can produce brand new supporting cells.

 

[FGG]

I wonder if there are any drugs in the works that can produce brand new supporting cells.

FX-322 doesn't deplete supporting cells. As far as fully regenerating them from epithelial cells, Chen at Harvard is working on this.

 

[JohnAdams]

I wonder if there are any drugs in the works that can produce brand new supporting cells.

Yes. I believe that one of the ingredients to FX-322 is valporic acid, which causes supporting cells to divide.

 

[JohnAdams]

Perhaps it is discussed somewhere in the thread, but I wonder if this drug will work for people that have tinnitus and healthy audiograms that do not show hearing loss? Sure there could be hidden hearing loss but because this isn't being tested for tinnitus without apparent HL, I'm not sure what it does for some of us.

@JohnAdams I believe you have pretty healthy audiograms and you're bullish on FX322 - what are your thoughts?

I don't think the healthy audiograms are telling the whole story with our ears. I think I wiped out what hair cells I had left above 15.5kHz.

 

[Caveman]

I don't think the healthy audiograms are telling the whole story with our ears. I think I wiped out what hair cells I had left above 15.5kHz.

What if the problem is in your auditory nerve?