Frequency Therapeutics — Hearing Loss Regeneration

[Paulmanlike]

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.

Mate believe me I have tinnitus. I can hear it now jolting around my head and been in hospital with depression induced tinnitus. So wind your neck in.

 

[john paul]

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

The problem is that doing a test on 28 people and then releasing something for the world to consume is complete madness. This trial is about working out the dosage amounts, the next trial is about safety and putting the nail in the coffin of any debate about safety and it working. After that they can take another risk and allow people to have it.

If you have hearing loss, get two audiograms together over the next 6 months and get in on the next larger trial. If they struggled to get 28 people together for this one they are going to need thousands for the next one which might hold things back even more.

 

[JohnAdams]

The problem is that doing a test on 28 people and then releasing something for the world to consume is complete madness. This trial is about working out the dosage amounts, the next trial is about safety and putting the nail in the coffin of any debate about safety and it working. After that they can take another risk and allow people to have it.

If you have hearing loss, get two audiograms together over the next 6 months and get in on the next larger trial. If they struggled to get 28 people together for this one they are going to need thousands for the next one which might hold things back even more.

This is the safety trial. If it also restores hearing what is a rational argument to make them do another trial for efficacy?

Madness is taking something that is safe and may also drastically improve the lives of millions of people and testing it over and over and over again I trials that take a year each.

 

[JohnAdams]

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.

Meant to say there AREN'T lgr5+ cells all through your head. This android spell check really sucks.

Congress and the President have both slammed the FDA for being too slow and I'm also pointing that out here and there are some really silly people casting super irrational arguments at me as to why we should just wait for the FDA process to run its course as if they are going to FDA fanatics or something.

The FDA is not our friend folks. They actually have approved many of the drugs that have caused many cases of tinnitus in the first place.

Doiiiiiippppp*****

 

[annV]

Meant to say there AREN'T lgr5+ cells all through your head. This android spell check really sucks.

Congress and the President have both slammed the FDA for being too slow and I'm also pointing that out here and there are some really silly people casting super irrational arguments at me as to why we should just wait for the FDA process to run its course as if they are going to FDA fanatics or something.

The FDA is not our friend folks. They actually have approved many of the drugs that have caused many cases of tinnitus in the first place.

Doiiiiiippppp*****

You'll absolutely never succeed in lobbying FDA to cut the red tape allowing FX-322 to be released faster than the guidelines state. It's hilarious to think a few hundred people from the internet could get something like that done.

Not to be mean, but... How can you be so gullible, JohnAdams? Am I the only one who thinks John here is out of his mind? Maybe wisdom does come with age...

 

[katri]

You'll absolutely never succeed in lobbying FDA to cut the red tape allowing FX-322 to be released faster than the guidelines state. It's hilarious to think a few hundred people from the internet could get something like that done.

Not to be mean, but... How can you be so gullible, JohnAdams? Am I the only one who thinks John here is out of his mind? Maybe wisdom does come with age...

Or pessimism. Tons of people are gullible but at the end of the day, people are entitled to their beliefs.

Even if the FDA doesn't cut the tape, what good are you doing talking crap about it?

People on this site need some form of hope. Do you want to yank it from them?

 

[Soren]

You'll absolutely never succeed in lobbying FDA to cut the red tape allowing FX-322 to be released faster than the guidelines state. It's hilarious to think a few hundred people from the internet could get something like that done.

Not to be mean, but... How can you be so gullible, JohnAdams? Am I the only one who thinks John here is out of his mind? Maybe wisdom does come with age...

Then it is good that there is an organization that is working to "cut the red tape" for drugs at the FDA. Namely Faster Cures https://www.fastercures.org/

"FasterCures praises efforts to modernize FDA drug review programs
This morning, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb made an important announcement, introducing five guidance documents that focus on advancing treatments for neurological disorders, an area in which there is a vast unmet need and lack of understanding.

"FasterCures is honored to have participated in the groundbreaking work that led to the commissioner's statement, and our team is eager to see progress toward treating the neurological conditions from which millions of patients suffer," said Tanisha Carino, executive director of FasterCures, a center of the Milken Institute. "This announcement speaks volumes to the exciting changes afoot in the biomedical R&D world."

FasterCures applauds the FDA's efforts to streamline its drug regulatory programs and to utilize patient organizations as partners and experts in R&D. The guidance documents are evidence of a commitment to building a more efficient, collaborative process through which we can speed up and improve the medical research system."​

 

[JohnAdams]

A few hundred people could get the attention of the ATA and the Wounded Warrior Project. They have more weight to throw around anyway.

Then it is good that there is an organization that is working to "cut the red tape" for drugs at the FDA. Namely Faster Cures https://www.fastercures.org/

​

"FasterCures praises efforts to modernize FDA drug review programs
This morning, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb made an important announcement, introducing five guidance documents that focus on advancing treatments for neurological disorders, an area in which there is a vast unmet need and lack of understanding.

"FasterCures is honored to have participated in the groundbreaking work that led to the commissioner's statement, and our team is eager to see progress toward treating the neurological conditions from which millions of patients suffer," said Tanisha Carino, executive director of FasterCures, a center of the Milken Institute. "This announcement speaks volumes to the exciting changes afoot in the biomedical R&D world."

FasterCures applauds the FDA's efforts to streamline its drug regulatory programs and to utilize patient organizations as partners and experts in R&D. The guidance documents are evidence of a commitment to building a more efficient, collaborative process through which we can speed up and improve the medical research system."​

​

Thanks for this, glad there's more people out there that understand this.​

 

[Enclave]

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.

This is misinformation at best.

FX-322 does NOT create new supporting cells. FX-322 makes a copy of an existing supporting cell, and that additional copy differentiates into a hair cell. The initial supporting cell that was copied in the first place remains intact and presumes its normal function and placement. There are no additional supporting cells created in aggregate.

Also, noise damage CAN damage supporting cells. This has been illustrated in research since at least 2013.

Everyone here needs to take @JohnAdams with a grain of salt. Review his posting history. He doesn't ever contribute factual updates or the latest breaking information.

He pollutes this thread with his opinions and loose understanding of the factual information at hand.

These threads would be significantly shorter and more informative if it weren't for people like him.

The greatest contribution John Adams can make to this forum would be to remove himself from it entirely.

 

[JohnAdams]

FX-322 does NOT create new supporting cells. FX-322 makes a copy of an existing supporting cell, and that additional copy differentiates into a hair cell. The initial supporting cell that was copied in the first place remains intact and presumes its normal function and placement. There are no additional supporting cells created in aggregate.

their technology creates more supporting cells as well.

How is copying supporting cells that differentiate into hair cells not the same as creating more supporting cells? They are created, then turn into hair cells. That's exactly what I meant. I never claimed there would be more in aggregate.

I think noise damage doesnt kill supporting cells

See how I said "I think", that's called an opinion. I never presented that as a fact. If you have evidence that noise exposure kills supporting cells too then please post the source instead of just launching personal attack against me. Thanks.

So if you could please enlighten us and post a link to your claim that would be great .

 

[katri]

The greatest contribution John Adams can make to this forum would be to remove himself from it entirely.

It's still a support forum. Once we start seriously kicking people out, we might be hurting them.

 

[Enclave]

It's still a support forum. Once we start seriously kicking people out, we might be hurting them.

This is a research update forum. This is NOT a support forum.

There is a forum here coincidentally called "Support". Please find your way there.

 

[katri]

This is a research update forum. This is NOT a support forum.

There is a forum here coincidentally called "Support". Please find your way there.

Where's the responses for John's last question? Because at least he is contributing to the conversation. He's updated articles, videos and emails so let's chill out here. You can ignore out of context posts and keep going. Or you could personally choose to argue the position he takes.

 

[JohnAdams]

There are no additional supporting cells created in aggregate.

From the Frequency Therapeutics patent:

"By way of further example, in one such embodiment the compound has the capacity to increase the cell density of Lgr5+ supporting cells in an in vitro population of cochlea supporting cells by factor of at least 100, at least 500, at least 1,000 or even at least 2,000"
https://patents.google.com/patent/US9968615B2/en​

So they can increase the numbers of supporting cells by a factor of up to 2,000.

I don't understand the personal attack on me. If I'm wrong you can post evidence and I will read it.

 

[Bart]

@JohnAdams,

I am wondering, I could be completely wrong here , but when hair cells or hairs die off, it leaves scar tissue so to speak, how do you regrow something on scar tissue?

I think this is more aimed at recent hearing loss, for example immediately after a noise trauma?

 

[katri]

From the Frequency Therapeutics patent:

"By way of further example, in one such embodiment the compound has the capacity to increase the cell density of Lgr5+ supporting cells in an in vitro population of cochlea supporting cells by factor of at least 100, at least 500, at least 1,000 or even at least 2,000"
https://patents.google.com/patent/US9968615B2/en​

So they can increase the numbers of supporting cells by a factor of up to 2,000.

I don't understand the personal attack on me. If I'm wrong you can post evidence and I will read it.

Wait it REPAIRS and PROLIFERATES the supporting cells?

 

[JohnAdams]

Wait it REPAIRS and PROLIFERATES the supporting cells?

I don't know about repairing. That would be super sweet though. I'll look into that.

@JohnAdams,


I am wondering, I could be completely wrong here, but when hair cells or hairs die off, it leaves scar tissue so to speak, how do you regrow something on scar tissue?

I think this is more aimed at recent hearing loss, for example immediately after a noise trauma?

That is a great question that I don't know the answer to.

 

[katri]

I don't know about repairing. That would be super sweet though. I'll look into that.

"The present invention relates to methods of inducing the self-renewal of stem/progenitor supporting cells, including inducing the stem/progenitor cells to proliferate while maintaining, in the daughter cells, the capacity to differentiate into hair cells. Specifically, the invention relates to methods of using compounds comprising a 3-(pyridin-2-yl)-1H-indol-2-ol containing moiety having a Formula I:"​

First part of the patent.

 

[katri]

@JohnAdams,

I am wondering, I could be completely wrong here , but when hair cells or hairs die off, it leaves scar tissue so to speak, how do you regrow something on scar tissue?

I think this is more aimed at recent hearing loss, for example immediately after a noise trauma?

I kinda doubt it. Scar tissue could be there for a good couple of reasons but it doesn't always mean that it's there. If that area is dead, then the nerves are too so they aren't sending out damaged signals that produce tinnitus. When people naturally lose their hearing the nerve is dead and it's all natural so they don't get tinnitus.

 

[JohnAdams]

@JohnAdams,

I am wondering, I could be completely wrong here , but when hair cells or hairs die off, it leaves scar tissue so to speak, how do you regrow something on scar tissue ?

I think this is more aimed at recent hearing loss, for example immediately after a noise trauma?

Wait it REPAIRS and PROLIFERATES the supporting cells?

The only mention of repair in the patent is this:

"In certain embodiments, the disclosure provides methods for maintaining or promoting the growth of cells of the auditory system in a subject comprising administering to said subject the compound described herein or derivative thereof or pharmaceutically acceptable salt thereof in an effective amount so as to augment or initiate endogenous repair, thereby maintaining or promoting the growth of cells of the auditory system in the subject."​

https://patents.google.com/patent/US9968615B2/en

 

[Johan_L]

This is the safety trial. If it also restores hearing what is a rational argument to make them do another trial for efficacy?

Madness is taking something that is safe and may also drastically improve the lives of millions of people and testing it over and over and over again I trials that take a year each.

Could it not be for identifying risks? (Headaches, long term cancer, etc).

Not that I wouldn't mind taking the risk tomorrow.

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.

Is there some regulation hindering them from saying this? Something like "16 out of 16 improved their hearing loss. We still need to do a phase 3 though."

Pretty interesting from a stock market perspective to get this info. I cannot buy shares in Frequency Therapeutics, but I can go short on hearing aid companies if it turns out this works (and make some $$$ when FX 322 puts them out of business).

 

[JohnAdams]

Could it not be for identifying risks? (Headaches, long term cancer, etc).

Not that I wouldn't mind taking the risk tomorrow.


Is there some regulation hindering them from saying this? Something like "16 out of 16 improved their hearing loss. We still need to do a phase 3 though."

Pretty interesting from a stock market perspective to get this info. I cannot buy shares in Frequency Therapeutics, but I can go short on hearing aid companies if it turns out this works (and make some $$$).

I concede that I'm actually ignorantly assuming they cant report those findings. From what I remember from school, they cant make any claims whatsoever about any aspect of it unless it is specifically studied and approved in that area.

Remember this isnt the first safety trial. They gave it to subjects last year. I doubt they would have started this years trial if that were the case. And you bring up a great point about the financial aspects of this. Very rich investors are keeping a very close eye on this, and probably internet support forums as well

 

[Johan_L]

I concede that I'm actually ignorantly assuming they cant report those findings. From what I remember from school, they can't make any claims whatsoever about any aspect of it unless it is specifically studied and approved in that area.

What have others communicated in early phases of trials?

I think saying "16 out of 16 saw signifcant improvements in hearing so we think this is very promising" is OK, but not stating "Our drug will cure hearing loss and it is safe drug.", for that they'll need more proof.

Very rich investors are keeping a very close eye on this, and probably internet support forums as well

I don't think they are, at least not many, not yet. That's why it would be an opportunity for us. If Hearing Aid companies drop slightly upon a succesful trial, that would be cool! (indicating investors are looking at this)

 

[Don Tinny]

Maybe I do not understand. But I imagine it is necessary for pharmaceutical companies to acquire the license to sell this drug worldwide, if it works. As I understand Frequency Therapeutics is a relatively small / medium company. Am I wrong?

 

[Zeneth]

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.

The mice didn't grow extra heads... so that's a good thing.

 

[JohnAdams]

Maybe I do not understand. But I imagine it is necessary for pharmaceutical companies to acquire the license to sell this drug worldwide, if it works. As I understand Frequency Therapeutics is a relatively small / medium company. Am I wrong?

Are you in the United States?

 

[Paulmanlike]

Maybe I do not understand. But I imagine it is necessary for pharmaceutical companies to acquire the license to sell this drug worldwide, if it works. As I understand Frequency Therapeutics is a relatively small / medium company. Am I wrong?

Yeah it's not even public (yet).

Hands up if you're gonna buy shares if it does go public - and the results continue to be promising. Nothing wrong with making a bit of money while getting cured at the same time.

 

[Don Tinny]

Are you in the United States?

No. Unfortunately I live in Argentina and I know I will have to wait longer to do the treatment. Anyway, here are some tinnitus centers that will surely be interested in having it available.

 

[JohnAdams]

No. Unfortunately I live in Argentina and I know I will have to wait longer to do the treatment. Anyway, here are some tinnitus centers that will surely be interested in having it available.

If you travel up here to get it you can stay at my place.

 

[Don Tinny]

If you travel up here to get it you can stay at my place.

Thanks JohnAdams. I appreciate your kindness.

If the drug is successful I will surely consider traveling as an option. I do not know how much longer it could take to be available in other countries.