Frequency Therapeutics — Hearing Loss Regeneration

[katri]

I'm not setting a date for my healing, just an expectation. We should all try to have that mentality.

 

[katri]

Do you think a mixture of FX-322 and OTO-413 would eliminate it?

 

[JohnAdams]

Do you think a mixture of FX-322 and OTO-413 would eliminate it?

I honestly think FX-322 will do it.

 

[katri]

This thread is dead. Is there anything else to talk about?¿

-We solved the nerve problem
-Tackled the shape of inner ear cells
-Debated over the connection of synapses
-Got over the amount possibly needed
-Debated the price
-Talked about the kinds of hearing loss that will benefit the most
-And looked into all the trial details

 

[Don Tinny]

This thread is dead.

At least until December, when we have the results of the last trial.

This thread is the most hopeful here.

 

[Contrast]

There was one smart investor that kept us up with everything on Frequency Therapeutics, I figured he would come back...

But I think MPP made him leave...

 

[JohnAdams]

This Reddit user is strongly suspected to be Will McLean of Frequency Therapeutics.

The Leviathan:

"Ultimately tinnitus comes down to hair cell damage/malfunction. Hearing loss might not be detected in people with tinnitus if the region responsible is small, and the nearby areas are excited by the traveling wave along the cochlea. Some ways to detect this are tone-matching experiments, and masking nearby regions. Either way, the fault lies in the hair cell, and regenerating or repairing those hair cells will help tinnitus. After all, the tinnitus is really just the brain filling in lost information not being relayed by hair cells".​

All eyes need to be on this. The FDA needs to let up on this company. Their procedural process is inadequate for the rapid advance in technology.

https://www.policymed.com/2016/10/fda-criticized-for-moving-too-slowly.html

"One report states that the FDA lacks goals, targets, and time frames for keeping up with scientific advances, while failing to track the money it spends on these efforts. The other report found fault with the FDA's strategic plan, which is supposed to speed approval of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots."​

We need to speak out with a unified voice. The drug companies can't really do it because they have a conflict of interest, it has to be us, the sufferers. Or we could just sit around and not be proactive and watch several more people off themselves and then click the hug emoji a bunch of times, while the FDA drags its ass.

The cure could already be here for most of us. If so, the only thing perpetuating our suffering is PROCEDURAL RED TAPE.

 

[grate_biff]

We need to speak out with a unified voice.

I´m with you all the way John. I have as much belief in Frequency Therapeutics as you.

Let´s just have it confirmed safe and hear what Frequency Therapeutics has to say after this phase.

Let´s hope there are also some positive news between the lines, regarding regain of hearing, tinnitus and hyperacusis.

Then I´ll do what ever I can to help speed things up, as I´m sure many others will as well.

Let´s find some patience, where there is none.

As, I´ve said before, I only live for this to succeed.

 

[JohnAdams]

I´m with you all the way John. I have as much belief in Frequency Therapeutics as you.

Let´s just have it confirmed safe and hear what Frequency Therapeutics has to say after this phase.

Let´s hope there are also some positive news between the lines, regarding regain of hearing, tinnitus and hyperacusis.

Then I´ll do what ever I can to help speed things up, as I´m sure many others will as well.

Let´s find some patience, where there is none.

As, I´ve said before, I only live for this to succeed.

Yeah, that's my point, wait until December, see what their report is, and then be like, "can we please know if the patients reported any tinnitus effects."

Super simple. We have a month and a half to two months. We need to be ready.

 

[Leoglobe]

We are more than ready

One thing that is still unclear to me: if you have no hearing loss within the normal range, but for example on at 14 kHz you have profound hearing loss like minus 80 or 90 decibels and that's where you have your tinnitus, Frequency Therapeutics won't be able to create new hair cells because there won't be enough support cells left in this area where it is actually the most needed?

I am just unclear about what the Reddit guy said about the profound hearing loss, does this comment apply to the hearing loss in general: if your hearing loss is profound then you need a cochlear implant, not Frequency Therapeutics, because you have no supporting cells left, or is this dependent on the frequency of hearing loss?

For me the former was the right explanation and as soon as you have some support cells Frequency Therapeutics could multiply them and put them where they are needed.

What do you think? Some people seem to think that this treatment will be dependent on the frequency of hearing loss and in this case that won't work for me and for some others... In my case I will still have my tinnitus at 14 kHz

 

[JohnAdams]

because there won't be enough support cells left in this area where it is actually the most needed?

Why won't there be enough supporting cells? I think noise damage doesnt kill supporting cells, only the hair cells. Now an ear infection definitely could kill any cells.
And even if that was so, their technology creates more supporting cells as well.

You have noise damage around 14k which is higher frequencies and the biggest, closest part of the cochlea is the higher frequencies therefore your case is the best for this drug to work.

 

[katri]

When was this posted?

 

[JohnAdams]

When was this posted?

Way back in 2013. They have had time to get their act together.

 

[Manny]

their technology creates more supporting cells as well.

How do you know this? I don't remember seeing it on the video.

 

[grate_biff]

because you have no supporting cells left

I would take this statement with a pinch of salt.
I mean, why would the progenitor cells die bc of hearing loss. We know they don´t regenerate on their own.
They are dormant and lie underneath the surface, so to speak(or actual literary). Why should they be affected by hearing loss? Profound or not? It just doesn´t make sense to why they are there in the first place!
Also, is your profound HL a result of loss to inner or outer HC´s
Maybe IHC and OHC are not profoundly lost on their own, but in combination.
Who is to say?

 

[grate_biff]

How do you know this? I don't remember seeing it on the video.

That's the whole idea behind FX-322.
The progenitor cells proliferate (divide) and then differentiate (regenerates).

http://www.frequencytx.com/our-approach/frequencys-origins.php

 

[JohnAdams]

Let's recount what we know so far.

1. Hearing (not just haircells) has been restored in mice, ly411575.
2. Hair cells have been shown to regrow in a human cochlea in vitro,
FX-322.
3. Hearing (not just haircells) has been shown to be partially restored in living humans by enhancing atoh1,
GCF-166.
4. FX-322 divides and multiplies supporting cells and induces hair cell regeneration, and the hair cells have functioning ribbon synapses.
5. Frequency Therapeutics has also demonstrated this process works in ototoxicity caused hair cell death.
6. Many of us got tinnitus from very loud noise which probably killed some hair cells.
7. A leading scientist from Frequency Therapeutics has purportedly stated that he thinks tinnitus is caused by loss or dysfunction of hair cells.
8. FX-322 has been shown to be safe per phase 1 trial last year.
9. 16 people, 8 with a low dose and 8 with a high dose of FX-322 are half way through the first real trial in humans with SNHL.
10. This trial will be over in December.

 

[Paulmanlike]

From what I can see it's only a safety trial of 24 patients, and all of them may not even have tinnitus in the first place?

 

[katri]

From what I can see it's only a safety trial of 24 patients, and all of them may not even have tinnitus in the first place?

They recruited people that have hearing loss due to noise trauma and ototoxicity.

The odds of them having tinnitus is larger than they not having tinnitus.

 

[Manny]

That's the whole idea behind FX-322.
The progenitor cells proliferate (divide) and then differentiate (regenerates).

http://www.frequencytx.com/our-approach/frequencys-origins.php

Thank you. I am going to go read up more thoroughly on this since I want to follow and discuss it.

 

[grate_biff]

From what I can see it's only a safety trial of 24 patients, and all of them may not even have tinnitus in the first place?

Well, they enrolled, exclusively, people with NIHL. Chances some of them have tinnitus is pretty big, I´d say!
Neither was having tinnitus an exclusion criteria.

 

[Paulmanlike]

Well, they enrolled, exclusively, people with NIHL. Chances some of them have tinnitus is pretty big, I´d say!
Neither was having tinnitus an exclusion criteria.

I wonder if they'll report it in December whether tinnitus was resolved or not. (That's even if it's successful at reversing hearing loss).

I have a normal audiogram but still tinnitus.

I wonder what the likes of people in my position would do if a treatment like FX-322 came to market "I want to fix my hearing loss that I don't have to see if it will resolve my tinnitus"

 

[grate_biff]

I want to fix my hearing loss

that I don't have

Or that don´t show on audiometric testing....

to see if it will resolve my tinnitus

If you're not afraid of needles, I´d try it, when eventually available!

 

[katri]

I wonder if they'll report it in December whether tinnitus was resolved or not. (That's even if it's successful at reversing hearing loss).

I have a normal audiogram but still tinnitus.

I wonder what the likes of people in my position would do if a treatment like FX-322 came to market "I want to fix my hearing loss that I don't have to see if it will resolve my tinnitus"

We all have hearing loss. It's just in the high frequencies. Audiograms don't always test as high so you never know your hearing isn't perfect.

 

[JohnAdams]

From what I can see it's only a safety trial of 24 patients, and all of them may not even have tinnitus in the first place?

Right, the official endpoint of this trial is safety. They have given 8 people a low dose and 8 a high dose and 8 a placebo. They are then testing their blood for trace amounts.

Think about it, the FDA will not allow a company to make claims about a drug unless it is FDA approved to do so. Therefore at the end of this trial the only claim they will legally be allowed to make is that it is safe because that's the official measure here. Even if all 16 patients had hearing restoration and tinnitus cured, the FDA would not allow them to claim that and thus sell it to cure that yet until they go through another drawn out trial to specifically assess that endpoint. Which could add years and years to the process.

I'm saying that's bullshit because the FDA should just allow them to compare these peoples audiograms pre and post this trial's treatment and then let that be the efficacy data and also allow them to simply say if it had an affect on their tinnitus without having to do 2 or 3 or more trials because this is a tragic emergency. The FDA process is very outdated and slow and is not designed to keep up with the rapid advancements in science. The President has said this, Congress has said this. It's probably more about keeping things slow to allow markets to adjust to new emerging technology that disrupts other markets. I say f÷<( the markets, our lives our more important than making sure investment bankers have time to reinvest. Boo hoo for them.

Why would they lie and say their tinnitus went away? Why would any of us lie and say we had tinnitus to get the drug when we didn't need it? Having an injection in your eardrum is not something I would have ever elected to do for fun.

If this stuff works by the end of next month, Frequency Therapeutics needs to be allowed to say it, and then the FDA needs to gtfoutta the way and let us have it.

Especially since it is safe, what could be the problem?

 

[Paulmanlike]

We all have hearing loss. It's just in the high frequencies. Audiograms don't always test as high so you never know your hearing isn't perfect.

I know that, but since my alledged hearing loss is not recognizable to me, this treatment would be of no interest to me if it didn't solve my tinnitus. Not slating them by the way, I hope they succeed, but I'm thinking of my own personal position and others.

I would also imagine tinnitus is more of a problem than a mild hearing loss.

 

[Paulmanlike]

Right, the official endpoint of this trial is safety. They have given 8 people a low dose and 8 a high dose and 8 a placebo. They are then testing their blood for trace amounts.

Think about it, the FDA will not allow a company to make claims about a drug unless it is FDA approved to do so. Therefore at the end of this trial the only claim they will legally be allowed to make is that it is safe because that's the official measure here. Even if all 16 patients had hearing restoration and tinnitus cured, the FDA would not allow them to claim that and thus sell it to cure that yet until they go through another drawn out trial to specifically assess that endpoint. Which could add years and years to the process.

I'm saying that's bullshit because the FDA should just allow them to compare these peoples audiograms pre and post this trial's treatment and then let that be the efficacy data and also allow them to simply say if it had an affect on their tinnitus without having to do 2 or 3 or more trials because this is a tragic emergency. The FDA process is very outdated and slow and is not designed to keep up with the rapid advancements in science. The President has said this, Congress has said this. It's probably more about keeping things slow to allow markets to adjust to new emerging technology that disrupts other markets. I say f÷<( the markets, our lives our more important than making sure investment bankers have time to reinvest. Boo hoo for them.

Why would they lie and say their tinnitus went away? Why would any of us lie and say we had tinnitus to get the drug when we didn't need it? Having an injection in your eardrum is not something I would have ever elected to do for fun.

If this stuff works by the end of next month, Frequency Therapeutics needs to be allowed to say it, and then the FDA needs to gtfoutta the way and let us have it.

Especially since it is safe, what could be the problem?

Slow down, it could grow you another head in a years time if these progenitor cells keep dividing and they will face all sort of legal issues then.

We all want a treatment ASAP, but these things have to be rigorously trialled for safety and efficacy.

 

[katri]

Slow down, it could grow you another head in a years time if these progenitor cells keep dividing and they will face all sort of legal issues then.

We all want a treatment ASAP, but these things have to be rigorously trialled for safety and efficacy.

Part of their solution causes it to stop dividing. There is literally no risk of cancer. It doesn't do that job forever.

 

[Manny]

Slow down, it could grow you another head in a years time if these progenitor cells keep dividing and they will face all sort of legal issues then.

We all want a treatment ASAP, but these things have to be rigorously trialled for safety and efficacy.

Will my new head come with new ears?

 

[JohnAdams]

FX-322 is not going to make people grow a new head. Just ignore comments like that. It's almost as if people that say stuff like that don't even have tinnitus and are here just trolling.

First off, there are lgr5+ progenitor cells all through your head, just your cochlea. The dose is small and will cycle out of your endolymph and they already stated they couldn't detect it in the first trial patients' blood.