Frequency Therapeutics — Hearing Loss Regeneration

[d'Wooluf]

Ditto man! In my case, they think it was from birth but I also had a few ear infections as an infant but I don't think that they said that was the cause (although they didn't necessarily rule it out).

Ototoxic antibiotics used to control the ear infections maybe?

especially in high frequencies.

...which suggests some form of sensorineural hearing loss.

I don't think any of us are guaranteed success with this, but I don't think many of us are totally ruled out either. I say be hopeful.

 

[Jason37]

Don't beat yourself up, man. You made a decision at the time that was a difficult judgement call to make, and you still don't know yet what the outcome will be for the people who have participated.

If it turns out to be safe and efficacious, then you will have the option, one day, to have it delivered into your cochlea safely and with the optimum dosage.

There is no correct decision with stuff like this. I had to make an incredibly hard judgement call when I was 19; I was given the option of major surgery for another condition, and I probably made the wrong choice. Yet if I didn't take it, I can guarantee I'd be living a life of regret now, wishing that I did. With decisions like these you simply cannot win.

Don't let any regrets eat you up. You made the right decision, because at the time you had weighed up the pros and cons and ultimately made a choice based on them. Stand by your convictions and don't let any doubts concern you at this point. We cannot change the path we're on.

Yeah that's true but it does suck thinking I could have been apart of history as one of the fist subjects to get their hearing restored. I hope I don't regret it down the road!

 

[Striveon]

I'm honored you seek my opinion.

To be honest. I don't know. I don't know enough about congenital hearing loss to form an opinion.

My opinion is thus: if you have NIHL or ototoxicity related hearing loss and tinnitus as a result, then it seems like it will help with that, especially high frequency hearing loss.

I also believe this will alleviate many cases of tinnitus. But what do I know?

Thank you for the information . I checked my documents and it says primary diagnosis: sensorineural hearing loss, but I am afraid I may be congenital, but who knows. I guess I'll just have to chill out. I just hope it would work in many of our cases. :/

 

[Deathtotinni]

It's not his opinions. I agree with his point of view wholeheartedly. I think that Frequency Therapeutics should hurry up, too.

If I may speak freely, the only time I had any interaction with him, he was kind of a jerk to me. I can only speak for myself, but I put JohnAdams on "ignore" not because I disagree with him, but because of the mean-spiritedness and arrogance he has displayed here. Life is bad enough with loud, screaming tinnitus without having to deal with jerks on a support forum.

I like John and haven't seen anything like that.

 

[SuntoryTime]

I like John and haven't seen anything like that.

You are very welcome to disagree with me. It won't hurt my feelings.

 

[Mata_CA]

So I started noticing tinnitus mid this year and visited my doctor who scheduled me with an ENT. I had an MRI done but everything appears normal. I have high frequency hearing loss, more so in my right ear. I have felt my hearing wasn't great for several years now, but only bothered getting it checked out when the ringing started. Thing is, I'm not sure why I even have hearing loss and neither was the ENT. I'm worried it could get worse... Anyone else in the same boat?

Anyway, I brought up Frequency Therapeutics to my ENT (I'm from Canada) and he said he's never heard of it. When I quickly described what they do and their trials, he pretty much disregarded it and said it's way too early for this kind of technology.

Now, he has a point that we are in the very early stages, but does that mean we won't see something working soon? I was a bit bothered that he had very little knowledge about this area of work since it seems to be promising. I don't know, I don't want to get my hopes up for no reason but also want to have hope that I can hear properly sometime soon.

One last question, I have hyperacusis and my ENT said I shouldn't wear earplugs when not in noise damaging environments (i.e. concerts) as it will make it worse. Is this true?

 

[Contrast]

Anyway, I brought up Frequency Therapeutics to my ENT (I'm from Canada) and he said he's never heard of it. When I quickly described what they do and their trials, he pretty much disregarded it and said it's way too early for this kind of technology.

Audiologists are hearing aid salesmen, not doctors or scientists that care about repairing the inner ear.
They don't care about suffering patients who want real help, disregard their ignorance. Scientific innovation will cuck them out of business. The question is when.

One last question, I have hyperacusis and my ENT said I shouldn't wear earplugs when not in noise damaging environments (i.e. concerts) as it will make it worse. Is this true?

Is your hyperacusis painful or do things sound too loud? Or both?

There isn't even research on hyperacusis but I do suspect hyperacusis with pain is a direct sign of the inner ear being damaged and having a lower tolerance to sound to prevent more damage.

 

[JohnAdams]

and said it's way too early for this kind of technology.

he said he's never heard of it.

 

[SuntoryTime]

Now, he has a point that we are in the very early stages, but does that mean we won't see something working soon? I was a bit bothered that he had very little knowledge about this area of work since it seems to be promising. I don't know, I don't want to get my hopes up for no reason but also want to have hope that I can hear properly sometime soon.

Try and get in on the Phase III Trial. These things take forever. Have hope, but keep your expectations realistic and you won't be disappointed. Here's some information regarding the time frame:

"How Close is a Hearing Loss Cure to FDA approval?
It takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. At first glance, the $32 million raised by the hardworking team at Frequency may seem impressive, but it is a small step on a long road to drug development.

"From petri dish to medicine cabinet you have to keep the FDA appraised of your entire process. That's how it works." -Snezana Markovic, Quality Assurance Manager, Lupin Pharmaceuticals

The Food and Drug Administration's goal is to protect the consumer and allow only vetted treatments to move to market. The FDA is clear and strict in the three phases a drug manufacturer must go through. Recall that our researchers are in Phase 1 of their clinical trials and have been allotted only 9 human adults as clinical trial patients. Luckily they've moved past the small-scale experiments on mice!

Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

The clinical trials for FX-322 have a chance to fail at either one of these hurdles. The process may take 10-15 years, even 20, depending on how effective the solution is, on how well the team sticks to protocol, and on how quickly the FDA turns things around on their end. The odds are stacked against them. Reuters reports that "63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III."

However, the researchers are gaining ground as they move towards Phase 2. In March of 2018, Science Magazine recognized Frequency Therapeutics' regeneration technology as a breakthrough in regenerative medicine. We wish them all the success and cross our fingers that some type of permanent treatment for hearing loss hits the consumer market."

Source:

https://bloomhearing.com/hearing-loss/stem-cells-show-promise-for-future-hearing-loss-cure/

 

[Ozwel]

Great article, many thanks for sharing. So if everything goes fine we'd have something on the market by 2023-2024. Fingers crossed. I'll still be pretty young to enjoy a new life, if 40 is considered as young.

 

[JohnAdams]

Frequency Therapeutics CEO David Lucchino @ 58:14

"The data has to continue to cooperate but so far so good and we'll look at our first batch of data early next year and then we'll plan our phase 2 studies to really prove it out and if we start to see what we think we have a potential to see ya know then you'd go to the FDA and you'd talk to them about Breakthrough or FastTrack status."

https://www.bloomberg.com/news/audi...iness-papa-ginos-rhode-island-elections-radio

"Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days."

"Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations."

https://en.wikipedia.org/wiki/Fast_track_(FDA)


"Novartis' imatinib (Gleevec) for CML -- Phase 1 trials began in June 1998, drug was approved 3 years later in May 2001 (FDA granted fast track and priority review; FDA review was a record 2.5 months)"

https://www.quora.com/What-have-been-the-fastest-FDA-drug-approvals-starting-from-an-IND​

Conclusion: if FX-322 does well, and gets approved as quick as Gleevec, then it could theoretically get approved by 2020.

 

[grate_biff]

drugs which treat a serious or life-threatening condition and fill an unmet medical need.

So our job then, as I see it, is as a community, to explain to the FDA that tinnitus and hyperacusis, as a result of hearing loss, is a SERIOUS condition, even though not fatal in itself, it can certainly be second handedly.

Believe me, they are not necessarily aware of this. And they won´t be unless we do not unite and tell them.

Thats the plan right, @JohnAdams??

Give @JohnAdams and me a genius-icon to this post if you are with us on our crusade to fast track this motherf*****, if there soon seems reason to do so......

 

[Contrast]

Try and get in on the Phase III Trial. These things take forever. Have hope, but keep your expectations realistic and you won't be disappointed. Here's some information regarding the time frame:

"How Close is a Hearing Loss Cure to FDA approval?
It takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. At first glance, the $32 million raised by the hardworking team at Frequency may seem impressive, but it is a small step on a long road to drug development.

"From petri dish to medicine cabinet you have to keep the FDA appraised of your entire process. That's how it works." -Snezana Markovic, Quality Assurance Manager, Lupin Pharmaceuticals

The Food and Drug Administration's goal is to protect the consumer and allow only vetted treatments to move to market. The FDA is clear and strict in the three phases a drug manufacturer must go through. Recall that our researchers are in Phase 1 of their clinical trials and have been allotted only 9 human adults as clinical trial patients. Luckily they've moved past the small-scale experiments on mice!

Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

The clinical trials for FX-322 have a chance to fail at either one of these hurdles. The process may take 10-15 years, even 20, depending on how effective the solution is, on how well the team sticks to protocol, and on how quickly the FDA turns things around on their end. The odds are stacked against them. Reuters reports that "63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III."

However, the researchers are gaining ground as they move towards Phase 2. In March of 2018, Science Magazine recognized Frequency Therapeutics' regeneration technology as a breakthrough in regenerative medicine. We wish them all the success and cross our fingers that some type of permanent treatment for hearing loss hits the consumer market."

Source:

https://bloomhearing.com/hearing-loss/stem-cells-show-promise-for-future-hearing-loss-cure/

I believe if things go well we could wait as little as 5-6 years. These statistics were before the public was informed about how slow and ineffective the FDA is. We have a political administration that will cut regulations and speed up medical breakthroughs as a natural consequence. Back in the 90's and even early 2000's researchers did not have the means to communicate with one another and share research actively like they do today.

More medical breakthroughs and discoveries are happening because the internet allows researchers to communicate and discuss ideas in real time, the public is even more informed what goes on in the lab, science is broken into laymen's terms.

People are aware that the FDA has shit regulations holding back reaction, people are aware of the monopoly. I highly doubt this will take 15-20 years.

 

[JohnAdams]

So our job then, as I see it, is as a community, to explain to the FDA that tinnitus and hyperacusis, as a result of hearing loss, is a SERIOUS condition, even though not fatal in itself, it can certainly be second handedly.

Believe me, they are not necessarily aware of this. And they won´t be unless we do not unite and tell them.

Thats the plan right, @JohnAdams??

There is no plan. I'd think we could affect the situation, but there are just too many nay sayers and pro government advocates in our community. The leaders of this site agree with the system and its process, and the ATA and BTA are complacent as well. I have tried to light a fire here and I have failed miserably.

If fx 322 was everything its cracked up to be and I ran the FDA, we woul have access to this in less than a year.

 

[Mata_CA]

Audiologists are hearing aid salesmen, not doctors or scientists that care about repairing the inner ear.
They don't care about suffering patients who want real help, disregard their ignorance. Scientific innovation will cuck them out of business. The question is when.


Is your hyperacusis painful or do things sound too loud? Or both?

There isn't even research on hyperacusis but I do suspect hyperacusis with pain is a direct sign of the inner ear being damaged and having a lower tolerance to sound to prevent more damage.

I thought ENTs are doctors? Pretty sure the one I visited is an actual doctor.

Yes, my hyperacusis makes certain sounds louder which in turn hurts my ears.

Try and get in on the Phase III Trial. These things take forever. Have hope, but keep your expectations realistic and you won't be disappointed. Here's some information regarding the time frame:

Don't think I can get in their trial since I'm in Canada. Thank you for the article though.

 

[d'Wooluf]

Does anyone have any corroboration for the FDA's slowness and ineffectiveness, "shit regulations", and "monopoly"? Is there some sort of groundswell of opinion on this in the wider (non-tinnitus) community? I have no knowledge of them at all.

I do expect any drug that I'm prescribed to be safe, and that means testing and verification by a third party. I would hope that that verification is rigorous and thorough (first priority) but also timely.

 

[grate_biff]

we woul have access to this in less than a year.

Maybe we can. I for one am gonna try my best to enroll in the next trial(s).

I wrote 3 email for this one. No reply.

Hopefully they will also go out of the US for the next.

 

[Hazel]

The leaders of this site agree with the system and its process, and the ATA and BTA are complacent as well. I have tried to light a fire here and I have failed miserably.

Your conspiracy theories are getting a bit tiresome. We are not complicit with anyone.

Of course the FDA is bureaucratic. But how could we, an organisation with nearly zero resources run entirely by volunteers, change the system? Only big powerful corporations who can spend millions of dollars lobbying the FDA might achieve anything in this regard. It's simply beyond our sphere of influence.

If it's so important to you why don't you do it yourself?

 

[grate_biff]

I thought ENTs are doctors?

They are, but when it comes to tinnitus, it doesn´t help. To my experience, audiologists are far more knowledgeable than ENTs. They think it´s on the table of neurologists. Followed that route back and forth

 

[JohnAdams]

The leaders of this site agree with the system and its process,

Your conspiracy theories are getting a bit tiresome

But generally speaking, man, I agree with the red tape and FDA.

 

[Markku]

@JohnAdams,

Shame on you taking things out of context.

The private message I sent to you said, in part, the following, which obviously makes it clear I forgot "don't" from the sentence in regards to red tape and the FDA.

But generally speaking, man, I agree with the red tape and FDA.

I believe people should be allowed to test drugs in early clinical phases if they are desperate.

People shouldn't be treated as incapable of making these life decisions.

Once they're properly told about the risks (some of which may be unknown in early clinical phases), a person should be able to make a decision if they want to take that risk. If the risk-benefit ratio is there for them in their thinking.

I believe same carries over euthanasia. A person who wants to end their life should have the right to do so at any point in their life, in a safe and loving setting, instead of having to resort to violent and unsure methods.

I believe in free will.​

 

[JohnAdams]

@JohnAdams,

Shame on you taking things out of context.

The private message I sent to you said, in part, the following, which obviously makes it clear I forgot "don't" from the sentence in regards to red tape and the FDA.

But generally speaking, man, I agree with the red tape and FDA.

I believe people should be allowed to test drugs in early clinical phases if they are desperate.

People shouldn't be treated as incapable of making these life decisions.

Once they're properly told about the risks (some of which may be unknown in early clinical phases), a person should be able to make a decision if they want to take that risk. If the risk-benefit ratio is there for them in their thinking.

I believe same carries over euthanasia. A person who wants to end their life should have the right to do so at any point in their life, in a safe and loving setting, instead of having to resort to violent and unsure methods.

I believe in free will.​

I'm done.
Bye.
Shame on me.

 

[Ed209]

For what it's worth, I agree that people should be allowed to take an experimental drug (where the risks are not known), if they believe it can save their life - and their sanity - and are happy to take the risk.

However, for every debate I've been involved in on this thread (and others), I was simply trying to steer the ship back towards reality. There is zero chance of anyone getting this drug in a year or less, so it's better that you remove these thoughts from your minds. It will never happen.

Don't forget that the FDA was criticised in a $1.8m report (by the IOM) in 2006 for not ensuring the safety of drugs. Because of this there was an overhaul of their regulations. Do you honestly think a few people on here can do anything to change their protocols? It's absurd.

Even with the backing of a huge legal team, and a decent budget, I still doubt we'd get very far.

 

[PDodge]

We all want this to work, and try it ASAP!

 

[lymebite]

In the United States (and probably other countries but I can only speak with good knowledge about the US) government institutions sometimes can change dramatically over time. The FDA seems to be doing just that, and it is happening in real time right now.

In today's issue of the Wall Street Journal newspaper, there is an article about how much faster the FDA has been moving - for example, the article says that over the last 20 months the FDA approved "an astounding 1,617 generic drugs" which is a large increase over prior years.

The current Commissioner of the FDA, Scott Gottlieb, has made a primary goal of his leadership to cut red tape and change the protocols at the FDA to enable speeding drugs (safely) to market.

Leaders like Gottlieb are always looking for "wins" they can point to as achievements - I wonder if FX-322 could be something that might catch his eye as a transformative therapy that could help millions of people, and therefore be a good win for him and the FDA.

Any of us could email him to mention how disabling severe tinnitus can be and ask that he do everything possible to speed FX-322 to market (safely) if the 2019 clinical trials are successful. His email address is:

CommissionerFDA@fda.hhs.gov

A few emails may do nothing, but you never know - one of them just might catch his attention.

Easy to google in more depth about what Scott Gottlieb is doing with the FDA, here is one example article:

FDA's Gottlieb Addresses Effort to Advance New Innovations

https://www.clinicalleader.com/doc/fda-s-gottlieb-addresses-effort-to-advance-new-innovations-0001

 

[1000]

In the United States (and probably other countries but I can only speak with good knowledge about the US) government institutions sometimes can change dramatically over time. The FDA seems to be doing just that, and it is happening in real time right now.

In today's issue of the Wall Street Journal newspaper, there is an article about how much faster the FDA has been moving - for example, the article says that over the last 20 months the FDA approved "an astounding 1,617 generic drugs" which is a large increase over prior years.

The current Commissioner of the FDA, Scott Gottlieb, has made a primary goal of his leadership to cut red tape and change the protocols at the FDA to enable speeding drugs (safely) to market.

Leaders like Gottlieb are always looking for "wins" they can point to as achievements - I wonder if FX-322 could be something that might catch his eye as a transformative therapy that could help millions of people, and therefore be a good win for him and the FDA.

Any of us could email him to mention how disabling severe tinnitus can be and ask that he do everything possible to speed FX-322 to market if the 2019 trials are successful. His email address is:

CommissionerFDA@fda.hhs.gov

A few emails may do nothing, but you never know - one of them just might catch his attention.

Easy to google in more depth about what Scott Gottlieb is doing with the FDA, here is one example article:

FDA's Gottlieb Addresses Effort to Advance New Innovations

https://www.clinicalleader.com/doc/fda-s-gottlieb-addresses-effort-to-advance-new-innovations-0001

@JohnAdams or someone with great convincing skills can try sending him an email?

 

[IAmCalifornia]

@Jason37 scary the risk of substantial hearing loss and it is what they are supposed to fix. I am so confused.

It's a pretty risky and invasive treatment, so there would definitely be risks.

In the United States (and probably other countries but I can only speak with good knowledge about the US) government institutions sometimes can change dramatically over time. The FDA seems to be doing just that, and it is happening in real time right now.

In today's issue of the Wall Street Journal newspaper, there is an article about how much faster the FDA has been moving - for example, the article says that over the last 20 months the FDA approved "an astounding 1,617 generic drugs" which is a large increase over prior years.

The current Commissioner of the FDA, Scott Gottlieb, has made a primary goal of his leadership to cut red tape and change the protocols at the FDA to enable speeding drugs (safely) to market.

Leaders like Gottlieb are always looking for "wins" they can point to as achievements - I wonder if FX-322 could be something that might catch his eye as a transformative therapy that could help millions of people, and therefore be a good win for him and the FDA.

Any of us could email him to mention how disabling severe tinnitus can be and ask that he do everything possible to speed FX-322 to market (safely) if the 2019 clinical trials are successful. His email address is:

CommissionerFDA@fda.hhs.gov

A few emails may do nothing, but you never know - one of them just might catch his attention.

Easy to google in more depth about what Scott Gottlieb is doing with the FDA, here is one example article:

FDA's Gottlieb Addresses Effort to Advance New Innovations

https://www.clinicalleader.com/doc/fda-s-gottlieb-addresses-effort-to-advance-new-innovations-0001

I will absolutely be sending an email.

Will you?

Every member here who cares about this should. Anyone who is tiredness of tinnitus and hearing loss and is on this forum should be doing this RIGHT NOW.

Just brought to plant to seed.

And maybe, maybe make a difference.

 

[Don Tinny]

The clinical trials for FX-322 have a chance to fail at either one of these hurdles. The process may take 10-15 years, even 20, depending on how effective the solution is, on how well the team sticks to protocol, and on how quickly the FDA turns things around on their end. The odds are stacked against them. Reuters reports that "63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III."

Oh, God: So I'm going to continue reading about neuromodulation or wait for a second miracle. A second chance.

If it takes 20 years I will be 53. My daughter will be 24. And my supporting cells will be dead, probably.

 

[Fabrikat]

A few emails may do nothing, but you never know - one of them just might catch his attention.

Thanks for this.

@lymebite, there's nothing like a bit of direct action, no matter how small, to make one feel even a fleeting sense of doing more than simply languishing helplessly.

I hope maybe we can let Mr. Gottlieb know that one of the US government's biggest compensation costs are the nearly 3 billion taxpayer's dollars, spent each year, on Veteran's disability payments for tinnitus and hearing deficits.

If he's after 'wins', I can't think of a more tangible one for the government, than that kind of saving, should any viable treatment come on board as soon as possible.

 

[Deathtotinni]

You are very welcome to disagree with me. It won't hurt my feelings.

I think I found the problem and it's not John.