Frequency Therapeutics — Hearing Loss Regeneration

Hi all,

I am affected by the disease alport syndrome. my doctor told me that the disease causes a genetic defect responsible for the fact that hair cells in the inner ear die off. the hearing loss is probably in the middle range, I was told. Does any of you know if frequency's therapy could be successful here?
yes, it will help if your hearing loss is not profound as long as Frequency succeeds.
 
how do you know that? Because I'm in the same situation, I am born with a genetic defect that has caused my hearing loss, and I wonder if this will help me.
upload_2018-7-12_12-1-36.png

as long as you are not near completely deaf you can probably get some hearing back.
 
how do you know that? Because I'm in the same situation, I am born with a genetic defect that has caused my hearing loss, and I wonder if this will help me.
also your tinnitus was caused by "genetic hearing loss" So why'd you put unknown?
 
yes, it will help if your hearing loss is not profound as long as Frequency succeeds.
My T has gotten better but my hearing has gotten worse and it's making me really tired all the time and avoid doing things. I'm not very active and I've always been in good shape and active. I'm only 29 and feel like I'm 70. My hearing loss is from imflimation and blood from a TBI I had in 2016. I fractured my skull. Don't worry I'm fairly normal I think. My MRIs are normal at least. I think my hearing is the root of my problems right now that and maybe fear of being hurt again so. When is frequency having another clinical trail? They said second half of the year which is now. I'm not super far from the HQ. I want to participate in the study. I'm really struggling with my hearing and getting tired.
 
Hi all,

I am affected by the disease alport syndrome. my doctor told me that the disease causes a genetic defect responsible for the fact that hair cells in the inner ear die off. The hearing loss is probably in the middle range, I was told.

Does any of you know if Frequency Therapeutics' could be successful here?
According to their working theory, yes. You may have to get multiple treatments though if the hair cells doe back off.
 
Between 0-1000 hz it is normal. 1000 hz and above it's hearing loss.
Almost as in the audiogram, see the picture.
don't expect a miracle unless it's proven that FX-322 can be reapplied many many many times and still be effective on duplicating progeintor cells. however I'm sure you will get some hearing back.
 
I always wondered why Frequency Tx conducted the Phase 1 trial in Australia instead of the United States.

Apparently there is an answer - and there will be a panel discussion about it on 9 October 2018 with David Lucchino as one of the speakers.

"Australia has its advantages as a place to conduct Phase I clinical trials: the right patient sub-populations for certain indications, speed, quality, tax incentives and acceptance of clinical trial data by other key markets. This forum will provide first-hand perspectives from MA companies who have conducted Phase I trials in Australia including how to select and work with partners who serve as your local legal entity, outsourced clinical trials provider and your liaison with Australian ethics and regulatory authorities to gain approvals. We'll also hear from some Australian service providers and our local Australian Trade and Investment representative on how to get started and proven practices for superior partnerships. Key audiences for this forum are R&D strategy and operations staff from small to mid-sized companies looking to conduct Phase I clinical trials in Australia."

https://www.massbio.org/events/the-phase-i-clinical-trial-experience-in-australia-2915
 
I only have hearing loss, no tinnitus.
My hearing loss is hereditary and I'm probably born with it. And almost the same as in the picture:
http://www.terracehearing.com/wp-content/uploads/2014/08/audiogram-presbyacusis-rgb.jpg

Are you sure it's hereditary? Cause it looks like a classic age/noise/medication related slope to me. Anyway, no-one here can say for sure what target groups this may or may not help. It's all just 'educated' guessing. I think you have just as much reason for hope as the rest of us. I see it as a ray of hope, but I'm not pinning my future on it. There are also many other projects out there.
 
what do you think how long fx takes until the treatment is on the market?
Will it be feasible within the next 5 years or will it take decades?
5-15 years
from best to worst case scenario outside of it failing.

The more people are vocal and interested, the quicker things will go.


It's ashame some people with hearing loss don't know know about this, or the cochlea, or hair cells, or anything. They just put on a hearing aid or live with a high frequency gap. Not showing any appreciation towards science that is trying to help them.
 
5-15 years
from best to worst case scenario outside of it failing.

The more people are vocal and interested, the quicker things will go.


It's ashame some people with hearing loss don't know know about this, or the cochlea, or hair cells, or anything. They just put on a hearing aid or live with a high frequency gap. Not showing any appreciation towards science that is trying to help them.

I'm curious. Why so long (assuming it doesn't fail)? And I don't want to start an argument about it but... what difference would it make if large numbers of people were vocal? The feeling I'm getting is that Frequency Therapeutics is an organisation made up of entrepeneurs. They are obviously kick-arse scientists, but they started Frequency Therapeutics to make money. They've got their ip locked down. They've got the funds they need to run their trials. It either works or it doesn't. I don't think they need or want a cheer squad.
 
Why so long (assuming it doesn't fail)?
Frequency hasn't started phase 2 yet.
  • Phase 2 can take several months to 2 years (approx. 33% of drugs move to the next phase)
  • Phase 3 can take 1 to 4 years (approx. 25-30% of drugs move to the next phase)
  • If phase 3 is successful a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval
 
Frequency hasn't started phase 2 yet.
  • Phase 2 can take several months to 2 years (approx. 33% of drugs move to the next phase)
  • Phase 3 can take 1 to 4 years (approx. 25-30% of drugs move to the next phase)
  • If phase 3 is successful a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval
So under 10% of trialed drugs make it through all three phases? Youch..
 
For anyone adventurous, no need to wait 5 to 15 years. As was posted earlier by @Aaron123 there seems to be an initial clinical trial site for patients to receive Frequency Tx FX-322 right now:

Worldwide Clinical Trials
2455 NE Interstate 410 Loop #150
San Antonio, TX 78217
Contact: Jeff Holland, Clinical Coordinator of Research, 210-387-0214

https://www.alamoent.com/wp-content/uploads/2018/07/Hearing-Loss-Study.pdf
 
For anyone adventurous, no need to wait 5 to 15 years. As was posted earlier by @Aaron123 there seems to be an initial clinical trial site for patients to receive Frequency Tx FX-322 right now:

Worldwide Clinical Trials
2455 NE Interstate 410 Loop #150
San Antonio, TX 78217
Contact: Jeff Holland, Clinical Coordinator of Research, 210-387-0214

https://www.alamoent.com/wp-content/uploads/2018/07/Hearing-Loss-Study.pdf
Maybe someone who talks english could call them and try to figure out if this is legit. The whole deal, just seems strange/unproffesional to me.
 
  • Phase 2 can take several months to 2 years (approx. 33% of drugs move to the next phase)
  • Phase 3 can take 1 to 4 years (approx. 25-30% of drugs move to the next phase)
  • If phase 3 is successful a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval

So potentially 5-6 years?

Here's the thing though from my understanding. This treatment has a couple of advantages when it comes to measuring efficacy and safety. First of all it's easily measurable. It's just a hearing test. There's no need for subjective measures. Secondly, it is applied in a relatively sealed-off area of the human body. It seems unlikely that an injection in the ear is going to affect your liver for example. If I remember correctly, one of the things they tested for in the phase one study was absence of the medication in other parts of the body. If you were testing a drug for cholesterol, for example, you would have to test for multiple interactions and systemic effects over a period of years. So maybe in this case we can shave some time off the averages?

Disclaimer: I didn't even do human biology in high school so you can safely ignore me.
 
Are you sure it's hereditary? Cause it looks like a classic age/noise/medication related slope to me. Anyway, no-one here can say for sure what target groups this may or may not help. It's all just 'educated' guessing. I think you have just as much reason for hope as the rest of us. I see it as a ray of hope, but I'm not pinning my future on it. There are also many other projects out there.

No, I'm not 100% sure, but a doctor told me that almost everyone with the form of hearing loss is hereditary.
 
What does it mean to have stable hearing loss?

I imagine it means that your hearing is not worsening on its own and is stable (ie if you were to sample your hearing every year, you wouldn't see any change from one year to the next). Some people with degenerative diseases or other health conditions see a degradation of their hearing with time.
 
We need someone from this forum on the inside of the clinical trial, even if there is all kinds of red tape and ndas just knowing that there is some improvement without having to wait another 2-3 years for the official results would be amazing. A simple yes or no my hearing/tinnitus has improved would be enough to ease my mind until it hits the market.
 

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