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Frequency Therapeutics — Hearing Loss Regeneration

#3,421
I think the multiple doses statement could be a positive. If one dose gives you 10 dB, they probably want to see if 5 doses gives you 50 dB. I don't think there is any implication that a single dose won't do any good. The article also mentions the fast track so they must be onto something.
 
#3,422
JohnAdams said:
Nothing is for sure, but it is looking like this will in fact recover some hearing loss, and that will likely have a positive impact on tinnitus. The mere fact that they are still moving along with it and getting investments is a good indicator.

That time frame I have proposed would be if everything goes well and they get granted fast track status.
Click to expand...
I truly hope all that you have said is what happens, I know it's not for sure, but I hope something can help us out here. If not, I hope you see improvement with the injections you got and that may be our cure. I'm so sick of this chronic illness. I'm just tired...
 
#3,425
Philip83 said:
Any particular reason for this?
Click to expand...
Yeah, when they were testing gamma secretase inhibitors on rats, first they gave it to them orally before they tried eardrum injections. The rats regained their hearing but their hair fell out, their skin changed color, and they developed skin tumors. Messing with cell signaling in this manner is potentially very dangerous.
 
#3,428
Piney said:
Any improvement I believe will help with everything. If I'm severely deaf now and If have to live with this 24/7 then any natural sound increasing has to be easier on the mental side. Of course we're all hoping for a reversal of hearing loss and maybe that will come as well. If CI implants sometimes lower tinnitus or knock it out then hearing improvement has to do something. That's my theory anyways.

For those who haven't had injections tell the doctor to have a steady hand, after the first one I was face down on the couch in the fetal position all night, he hit my skinny inner ear canal.

For those who had 72 injections, let it be known you're made of metal.
Click to expand...
I've had a CI for about 29 years so let me tell you it doesn't knock out the tinnitus at all. It might lessen it a bit but as far as eradicating tinnitus, no way! Constant hissing, humming for 38 years...
 
#3,429
JohnAdams said:
Yeah, when they were testing gamma secretase inhibitors on rats, first they gave it to them orally before they tried eardrum injections. The rats regained their hearing but their hair fell out, their skin changed color, and they developed skin tumors. Messing with cell signaling in this manner is potentially very dangerous.
Click to expand...
Ah ok, so there are some safety concerns even with injections at high doses after all?
 
#3,430
RB2014 said:
I think the multiple doses statement could be a positive. If one dose gives you 10 dB, they probably want to see if 5 doses gives you 50 dB.
Click to expand...
The decibel scale doesn't work like that. For example, if one dose gives 10 dB improvement, a second dose would only amount to a 13 dB improvement, and 5x a little over 16 dB improvement. And that's only if the subsequent doses improved hearing by exactly the same amount as the first dose.
 
#3,431
Flamingo1 said:
The decibel scale doesn't work like that. For example, if one dose gives 10 dB improvement, a second dose would only amount to a 13 dB improvement, and 5x a little over 16 dB improvement. And that's only if the subsequent doses improved hearing by exactly the same amount as the first dose.
Click to expand...
True, assuming a linear improvement. However, the effect might be exponential...
 
#3,434
JohnAdams said:
Yeah, when they were testing gamma secretase inhibitors on rats, first they gave it to them orally before they tried eardrum injections. The rats regained their hearing but their hair fell out, their skin changed color, and they developed skin tumors. Messing with cell signaling in this manner is potentially very dangerous.
Click to expand...
So you're saying that I can eat FX-322... Seems like a pretty small price to pay to get my hearing back and my tinnitus gone. No hair, I turn blue with skin tumors... hmmmmmm. I could start a new race of super beings. Maybe that's how we are all supposed to evolve...

Good points on the dB example I posted. Agreed with the guys who said that there would be diminishing returns. There is no good reason why it would be exponential, and linear like I mentioned doesn't make sense either.
 
#3,435
RB2014 said:
So you're saying that I can eat FX-322... Seems like a pretty small price to pay to get my hearing back and my tinnitus gone. No hair, I turn blue with skin tumors... hmmmmmm. I could start a new race of super beings. Maybe that's how we are all supposed to evolve...

Good points on the dB example I posted. Agreed with the guys who said that there would be diminishing returns. There is no good reason why it would be exponential, and linear like I mentioned doesn't make sense either.
Click to expand...
Just an example:

Say it turns out you need the cochlea to be continuously exposed for 10 days for a hair cell to fully grow.

If an injection stays say two days in the cochlea, one injection would have zero effect as the hair cells would not develop within that time. Two injections would also have zero effect has well, but five would have "full effect".

(This example has no basis in any data posted by Frequency Therapeutics or other source)
 
#3,436
Johan_L said:
Say it turns out you need the cochlea to be continuously exposed for 10 days for a hair cell to fully grow.
Click to expand...
I think once the cell is signaled the process just starts and finishes on its own. I really don't think it will need to to be continuously exposed while the hair cell grows to maturity.
 
#3,437
JohnAdams said:
I think once the cell is signaled the process just starts and finishes on its own. I really don't think it will need to to be continuously exposed while the hair cell grows to maturity.
Click to expand...
This makes sense to me. As far as I know stem cells in the womb gets a command and then they fullfil it. It's not like someone needs to check in and refresh the memory of the cell about what it should become.
 
#3,438
I'm curious what the impact of the Fast Track Status will actually mean for the availability of FX-322 in the market place. Any ideas? The FDA has 60 days to respond once Frequency Therapeutics has raised the request for getting that status. So that may explain the radio silence as we are in that 60 days time limit.
 
#3,439
Coleoptere said:
I'm curious what the impact of the Fast Track Status will actually mean for the availability of FX-322 in the market place. Any ideas? The FDA has 60 days to respond once Frequency Therapeutics has raised the request for getting that status. So that may explain the radio silence as we are in that 60 days time limit.
Click to expand...
I'm pretty sure they want/need to conduct the phase 2 study (and phase 3?) before they ask for a fast-track?

I think there is no official word on when phase 2 will begin yet though, right? Or finish for that matter.
 
#3,440
Philip83 said:
I'm pretty sure they want/need to conduct the phase 2 study (and phase 3?) before they ask for a fast-track?
Click to expand...
"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 make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition."

https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
 
#3,441
JohnAdams said:
That's not how it works.
The drug is injected via the eardrum into the middle ear and then diffuses through the round window membrane.
Go look at a 3D anatomical model of the ear, you will see that getting a needle into the eardrum and then the round window membrane would be extremely difficult.
Click to expand...
Well Frequency Therapeutics was on ABC News two days ago. Gotta be a good sign!!

 
#3,447
upload_2019-3-5_15-45-56.png

upload_2019-3-5_15-46-7.png

:wacky:
 

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