Frequency Therapeutics — Hearing Loss Regeneration

#2,341
@JohnAdams this place will be dead if you leave lmao. I'm going to work on a ton of lists on why this would work and why it wouldn't.

If tinnitus can start then it can stop, no matter how terrible it is. People that get tinnitus from their diets, dental issues, etc have it resolved as soon as the underlying cause is corrected. It wouldn't be a far reach to assume this is the underlying cause that can be corrected, right?
 
#2,342
katri said:
Where else can we put our energy? I'm kinda lost in life right now.
Click to expand...

As I understand it, you're still a minor and you have school and lots of other things to worry about in your life so perhaps focus on those.

If you're still longing to put your energy towards something bigger, there's a lot going on behind the scenes on Tinnitus Talk. Trust me, the mods and founders of this site aren't just sitting back on their hands. They're actively doing stuff for everyone's benefit. There's also a lot of us that are volunteering behind the scenes too. :)
 
#2,343
katri said:
If tinnitus can start then it can stop, no matter how terrible it is.
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Are you sure this is true? How can you know? What about other neurological afflictions that have no cures (ALS... to name one). ALS starts, won't stop. All these theories about tinnitus are just theories... :rolleyes:
 
#2,345
annV said:
Are you sure this is true? How can you know? What about other neurological afflictions that have no cures (ALS... to name one). ALS starts, won't stop. All these theories about tinnitus are just theories... :rolleyes:
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Let me ask you this:
If someone poked your eye out, and left you half way blind.
Would you call it a neurological affliction?
 
#2,346
annV said:
Are you sure this is true? How can you know? What about other neurological afflictions that have no cures (ALS... to name one). ALS starts, won't stop. All these theories about tinnitus are just theories... :rolleyes:
Click to expand...

We already have people that have had complete resolution of their tinnitus from various reasons ranging all from cochlear implants to having a stroke. One can also alleviate tinnitus by injecting lidocaine intravenously, that would give you silence for about 30 min. So clearly it's possible, there is no doubt about that. The question is how to do it for everyone in a safe manner. Because having cochlear implants isn't a viable option and the resolution frequency is far from 100%. And I don't have to explain why inducing a stroke might be a bad idea, right?
 
#2,347
I think that tinnitus is in the brain because it is related to the number of neurons disconnected from their hair cells and therefore getting excited by looking for the lost frequency signal.

My grandfather was really deaf but didn't have tinnitus because his hearing loss was very gradual and he became deaf at 70, he didn't have many auditory neurons left maybe, they maybe pretty much died at the same time as his hair cells.

On this forum on the contrary there are a lot of young people with loud tinnitus and minimal hearing loss, they got this from a shock usually (acoustic or ototoxic) and I suppose that as they are young their neurons are very healthy and actively looking for the hair cells but those have been destroyed.

By the way someone of my family had tinnitus and then a stroke and indeed his tinnitus vanished but he lost heaps of neurons and actually behaves like a kid.

I didn't believe at all in the previous clinical trials that Auris Medical conducted but I truly believe that Ffequency Therapeutics should do the trick for most of us.

We need this synapse between the hair cells and neurons to happen and once the hair cells at the frequency x are back, then the neuron at the frequency x will find it. Neurons can live for a very long time even if the hair cells are dead.
 
#2,348
I think we do not have to over-analyze it so much. Even if your tinnitus does not disappear completely after the injection

"The better you hear, the less you hear your tinnitus".
 
#2,350
No one with hidden hearing loss will be eligible for FX-322 thanks to the 250 Hz - 8 kHz tonal audiogram which is the main factor of determining results of this trial as far as I know.
 
#2,351
Neurons don't die like that, usually they can die from an oxygen deprivation in the case of a stroke, a head trauma or aging so I wouldn't worry about this.

And I agree with @Contrast in regards to the hidden hearing loss which is also the case for me, I would then have to wait for the drug to be released and I will get it like this instead of getting it via a trial.
 
#2,352
Leoglobe said:
And I agree with @Contrast in regards to the hidden hearing loss which is also the case for me, I would then have to wait for the drug to be released and I will get it like this instead of getting it via a trial.
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Same! Just hope I'll find an ENT who would give it to me...
 
#2,353
Once it is released, we will be able to get it. There will be a way, I am not worried about this.

For the trials they need an objective measure so that's why they don't open them to tinnitus sufferers without hearing loss up to 8 kHz.
 
#2,354
I would even say... once Frequency Therapeutics's cure is realised, ENTs will finally have a reason to start measuring above 8 kHz.

Today what's the point of measuring high frequency hearing loss... to determine the cause of your tinnitus? There's no cure so there's no point... and no hearing aid covers that part of the spectrum.
 
#2,355
Pero1234 said:
Today what's the point of measuring high frequency hearing loss... to determine the cause of your tinnitus? There's no cure so there's no point... and no hearing aid covers that part of the spectrum.
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If used properly it's an indicator of hearing loss when compared to the predicted high frequency hearing of the patient's age cohort.

That information could then be used to change behavior or to prescribe vitamins/earplugs/hearing protective NAC etc.

This could and should be standard practice for all ENTs.

Not having the equipment and implementing this frequency range hearing test is malpractice.
 
#2,358
Street Novelist said:
Didn't Trump pass a law giving people the right to try drugs in the clinical trial phase without approval from the FDA? How exactly does that work? Anyone know?
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Yeah it's mainly for fatal diseases and the drugs just have to pass phase 1 safety trials. It'd be nice if FX-322 works well and could qualify for this. Maybe it will be awesome and work perfectly and will qualify for this and fate would conspire in our favor just like luck conspired to fuckin ruin our lives in the first place.
 
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#2,359
JohnAdams said:
Yeah it's mainly for fatal diseases and the drugs just have to pass phase 1 safety trials. It'd be nice if FX-322 works well and could qualify for this. Maybe it will be awesome and work perfectly and will qualify for this and fate would conspire in our favor just like luck conspired to fuckin ruin our lives in the first place.
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FX-322 is not considered as a priority today, it's just "another drug test part of 40,000 others". It will not benefit from fast track unless people with tinnitus in the US are recognized as people with a serious problem. At this time people with tinnitus are just people living their lives like other people, for years and years and noone is dying from it (apart from suicides but it is from depression and not tinnitus in their medical records).

People suffering from hearing loss are not considered as a priority either. The only thing that could trigger a fast track process is money, and if this works there will be a war first to know which company will buy Frequency Therapeutics while competition will try to "kill a few people" (it's an image, no conspiracy) because we're talking about billions of dollars.

So here we are:
1) we are still waiting for the drug to be tested and fingers crossed: it to be efficient. That is one big step and we have to wait for this before "screaming" for it.
2) once it's proven efficient (a 2-year process?), we'll have to wait for "companies marketo", then admin procedures, and finally we can hope for a few ENTs to be early adopters and have them get you a place in their agenda for the next 6 months.

When you see things like this, you can't be disappointed.
 
#2,361
Ozwel said:
FX-322 is not considered as a priority today, it's just "another drug test part of 40,000 others". It will not benefit from fast track unless people with tinnitus in the US are recognized as people with a serious problem. At this time people with tinnitus are just people living their lives like other people, for years and years and noone is dying from it (apart from suicides but it is from depression and not tinnitus in their medical records).

People suffering from hearing loss are not considered as a priority either. The only thing that could trigger a fast track process is money, and if this works there will be a war first to know which company will buy Frequency Therapeutics while competition will try to "kill a few people" (it's an image, no conspiracy) because we're talking about billions of dollars.

So here we are:
1) we are still waiting for the drug to be tested and fingers crossed: it to be efficient. That is one big step and we have to wait for this before "screaming" for it.
2) once it's proven efficient (a 2-year process?), we'll have to wait for "companies marketo", then admin procedures, and finally we can hope for a few ENTs to be early adopters and have them get you a place in their agenda for the next 6 months.

When you see things like this, you can't be disappointed.
Click to expand...
It will be able to benefit from fast track if they consider hearing loss a serious condition.

Hearing loss from WHO:

Key facts
  • Around 466 million people worldwide have disabling hearing loss (1), and 34 million of these are children.
  • It is estimated that by 2050 over 900 million people will have disabling hearing loss.
  • Hearing loss may result from genetic causes, complications at birth, certain infectious diseases, chronic ear infections, the use of particular drugs, exposure to excessive noise, and ageing.
  • 60% of childhood hearing loss is due to preventable causes.
  • 1.1 billion young people (aged between 12–35 years) are at risk of hearing loss due to exposure to noise in recreational settings.
  • Unaddressed hearing loss poses an annual global cost of US$ 750 billion. Interventions to prevent, identify and address hearing loss are cost-effective and can bring great benefit to individuals.
  • People with hearing loss benefit from early identification; use of hearing aids, cochlear implants and other assistive devices; captioning and sign language; and other forms of educational and social support

FDA Breakthrough Therapy:

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

For purposes of Breakthrough Therapy designation, clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

  • An effect on an established surrogate endpoint
  • An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical benefit (i.e., the accelerated approval standard)
  • An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the underlying disease
  • A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy
A drug that receives Breakthrough Therapy designation is eligible for the following:

  • All Fast Track designation features
  • Intensive guidance on an efficient drug development program, beginning as early as Phase 1
  • Organizational commitment involving senior managers
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation.

Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.​

I think it is possible for FX-322 to get this.
 
#2,362
Were any of the Frequency Therapeutics studies done on live mice? Did they expose them to noise and then inject FX-322?

Or did they expose them to the noise, wait a while and then took out the cochlea and experiment?
 
#2,363
katri said:
Were any of the Frequency Therapeutics studies done on live mice? Did they expose them to noise and then inject FX-322?

Or did they expose them to the noise, wait a while and then took out the cochlea and experiment?
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Both. They also ablated their hair cells with ototoxic chemo drugs and regrew the cells too. But yeah, they did this in living mice. They also did it in an explanted cochlea from a brain tumor patient and the process worked in it as well.

Also the entire endpoint is the restoration of hearing, which another drug, CGF166 was shown to work in living humans.

FX-322 is more sophisticated than that drug as well. So far there is much to be hopeful about.
 
#2,364
JohnAdams said:
Both. They also ablated their hair cells with ototoxic chemo drugs and regrew the cells too. But yeah, they did this in living mice. They also did it in an explanted cochlea from a brain tumor patient and the process worked in it as well.

Also the entire endpoint is the restoration of hearing, which another drug, CGF166 was shown to work in living humans.

FX-322 is more sophisticated than that drug as well. So far there is much to be hopeful about.
Click to expand...
Do we know how much hearing it was that was regenerated?
 
#2,365
JohnAdams said:
Both. They also ablated their hair cells with ototoxic chemo drugs and regrew the cells too. But yeah, they did this in living mice. They also did it in an explanted cochlea from a brain tumor patient and the process worked in it as well.

Also the entire endpoint is the restoration of hearing, which another drug, CGF166 was shown to work in living humans.

FX-322 is more sophisticated than that drug as well. So far there is much to be hopeful about.
Click to expand...
So they put it in mice and waited months before they killed them and examined it all?
 
#2,366
katri said:
What makes Frequency Therapeutics better than Novartis? In terms of treatment.
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The Novartis drug only introduces Atoh1 into the supporting cells, the Frequency Therapeutics method uses a combination of like 4 different small molecule drugs to divide the supporting cells, grow the cells in the right pattern etc.

Go check out that Will McLean YouTube presentation, the one that's about 24 minutes long.
 
#2,367
katri said:
So they put it in mice and waited months before they killed them and examined it all?
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I don't know about the durations. Will McLean at the end of his presentation seemed to think as long as there are still lgr5+cells present that the treatment should work and that they seem to persist long after damage. Go watch the video.
 
#2,368
JohnAdams said:
I don't know about the durations. Will McLean at the end of his presentation seemed to think as long as there are still lgr5+cells present that the treatment should work and that they seem to persist long after damage. Go watch the video.
Click to expand...
Sounds scary. How much longer do we have to wait for the treatment to become available? It has been 1 year since my tinnitus worsened.

I hope I can qualify for this treatment, if it is successful.
 

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