Frequency Therapeutics — Hearing Loss Regeneration

#2,311
JohnAdams said:
I cannot possible understand why people on this forum that have NIHL and ototoxicity induced hearing loss aren't intensely focused on this drug.
Click to expand...

Hello, I got my tinnitus in 2014 and it has worsened 5 times since then.

I am trying to not let myself become so intensely focused on this drug because it has a chance to fail.

I've seen several "chosen one" drugs that were supposed to help us over the last four years get hyped up just like this one and ended up failing before it's even out of phase 1 or 2. A lot of people were let down and found it hard to reconcile with, including myself. Many members, like Danny, put their lives at risk to try things that ended up not having as big of an impact as they thought it would or worse, it caused new health challenges they hadn't anticipated.

This drug has a chance to fail just like every other. If it does, its creators and founders will not be any the worse for wear. They will close the company down and leave it with their pockets lined.

I'm not saying don't have hope because that's what gets a lot of us through the day. I'm saying don't put all your eggs in one basket. Don't put your mental health and even your very life on this drug. That's extremely dangerous thinking.
 
#2,312
derpytia said:
Hello, I got my tinnitus in 2014 and it has worsened 5 times since then.

I am trying to not let myself become so intensely focused on this drug because it has a chance to fail.

I've seen several "chosen one" drugs that were supposed to help us over the last four years get hyped up just like this one and ended up failing before it's even out of phase 1 or 2. A lot of people were let down and found it hard to reconcile with, including myself. Many members, like Danny, put their lives at risk to try things that ended up not having as big of an impact as they thought it would or worse, it caused new health challenges they hadn't anticipated.

This drug has a chance to fail just like every other. If it does, its creators and founders will not be any the worse for wear. They will close the company down and leave it with their pockets lined.

I'm not saying don't have hope because that's what gets a lot of us through the day. I'm saying don't put all your eggs in one basket. Don't put your mental health and even your very life on this drug. That's extremely dangerous thinking.
Click to expand...
This drug is not like any of the others that have preceded it. This is in a category called REGENERATIVE MEDICINE. If tinnitus is bothering you in any degree then you should jump on the bandwagon.
 
#2,315
jeff W said:
That is fair response. I am simply brutal on failure, I see it as my responsibility to hack at these companies.
Click to expand...
I don't see how that's productive, though. I admit I haven't been that involved in this thread or reading about research as a whole in the past year or so, but when I was new to tinnitus I obsessively read about new research and even picked the brains of a number of researchers in person.

At a certain point I just realized how far off we are to a cure and that putting all my hope in one was a mistake. I hope Frequency Therapeutics is successful, but if they fail people will be saying the same thing.

Like @derpytia said, I too have seen a number of promising drugs or treatments come and go, and the amount of speculation in this thread reminds me of them.

Every failure pushes us a little closer to the goal if we can take something away from it.
 
#2,316
Alue said:
Like @derpytia said, I too have seen a number of promising drugs or treatments come and go, and the amount of speculation in this thread reminds me of them.
Click to expand...

Perhaps there are reasons to believe the preclinical research indicates a higher likelihood of success this time.

How well have they been able to regenerate hearing in rats, from 0% to 100% or from say 20% to 40%?

I am also thinking that indications of improving hearing loss in rodents is more robust than decreasing tinnitus, which would mean more certainty of potential efficacy this. (tinnitus is more difficult to measure)
 
#2,317
@Deathtotinni I have searched your posts and I am very happy to see you are active again. I have read in another thread that from your knowledge the drug seems to be safe but still no news if it works. Is that right? Please update us!
 
#2,324
Gorbeh3 said:
Under normal circumstances I would agree with this time line, however, this is not normal circumstances.

If phase 2 shows positive results there is going to be immense pressure to get this out ASAP by the US government for veterans.

https://www.military.com/benefits/v...us-is-number-one-disability-for-veterans.html
Click to expand...

The D-Methionine trial was being funded by the government aimed at active military. It died in Phase 3 due to funding. I wouldn't believe it until I see it.

https://clinicaltrials.gov/ct2/show/NCT02903355
 
#2,325
Johan_L said:
Perhaps there are reasons to believe the preclinical research indicates a higher likelihood of success this time.

How well have they been able to regenerate hearing in rats, from 0% to 100% or from say 20% to 40%?

I am also thinking that indications of improving hearing loss in rodents is more robust than decreasing tinnitus, which would mean more certainty of potential efficacy this. (tinnitus is more difficult to measure)
Click to expand...

Sometimes it doesn't matter whether a drug is effective enough or not. There is a whole host of other reasons that a clinical trial can fail. And once it fails because of those reasons it's extremely hard for a company to get on track. So far, what I've seen of Frequency Tx and how they operate leans towards positive thinking. But it still isn't healthy to be so hyperfixated on this. There's so much energy being put into speculation and waiting here when I believe that energy could be put to better use.

Again, I'm not saying to abandon all hope. I'm saying that speculation and hyperfixation does you no good in the long run.
 
#2,326
I am not jumping on any hysteric band wagon yet. There is still a long way to go with this drug and there is still great risk that it will fail.

It is good to have hope but there is one thing worse then hope and that is FALSE hope. That can really destroy you. I am not putting any hope up until many people have received this drug and report back that it has lowered their tinnitus. Only THEN will I get exited.
 
#2,328
vttbx said:
The D-Methionine trial was being funded by the government aimed at active military. It died in Phase 3 due to funding. I wouldn't believe it until I see it.

https://clinicaltrials.gov/ct2/show/NCT02903355
Click to expand...
Exclusion criteria: (...) or asymmetric hearing worse than 25 dB at any frequency in either ear, (...)

I think they couldn't find suitable people.
 
#2,329
derpytia said:
Sometimes it doesn't matter whether a drug is effective enough or not. There is a whole host of other reasons that a clinical trial can fail. And once it fails because of those reasons it's extremely hard for a company to get on track. So far, what I've seen of Frequency Tx and how they operate leans towards positive thinking. But it still isn't healthy to be so hyperfixated on this. There's so much energy being put into speculation and waiting here when I believe that energy could be put to better use.

Again, I'm not saying to abandon all hope. I'm saying that speculation and hyperfixation does you no good in the long run.
Click to expand...
There are 16 people with SNHL that have been given the drug. There will definitely not be a placebo effect here. 8 had the low dose, 8 had the high dose. Are you not extremely interested in whether or not a) it worked and b) if they had tinnitus and it went away? I am hyper interested.

The only thing keeping us from this knowledge at the end of this trial is now just arbitrarily imposed secrecy. Yay secrecy!
 
#2,331
JohnAdams said:
There are 16 people with SNHL that have been given the drug. There will definitely not be a placebo effect here. 8 had the low dose, 8 had the high dose. Are you not extremely interested in whether or not a) it worked and b) if they had tinnitus and it went away? I am hyper interested.

The only thing keeping us from this knowledge at the end of this trial is now just arbitrarily imposed secrecy. Yay secrecy!
Click to expand...
I think there's a good chance it might work because the company is open about most of its announcements and goals. They work hard to keep their research in the news. Most other trials wouldn't let us know how they want to improve myelin and other crap. Why would they lay out their next step before they've even finished 1b?

Also if it's proven effective then they'd gain investors or get more people to invest anyway. Frequency Therapeutics isn't the only company working towards the same goals and it's kinda fun to follow.
 
#2,332
The only choice for tinnitus sufferers. FX-322 is on the right track, not patches, not bandaids... They are working towards a HEARING LOSS CURE. It also has the highest probability of being able to cure tinnitus as well without cutting the auditory nerve. It could also be effective for hyperacusis, for anything that is related to sensorineural hearing loss.

I spoke to the ENT secretary from San Antonio. They have big hopes on Frequency Therapeutics and FX-322. She also mentioned that she was told that they are working on more stuff.

Tinnitus is a major concern, believe it or not, they are aware.
 
#2,333
1000 said:
The only choice for tinnitus sufferers. FX-322 is on the right track, not patches, not bandaids... They are working towards a HEARING LOSS CURE. It also has the highest probability of being able to cure tinnitus as well without cutting the auditory nerve. It could also be effective for hyperacusis, for anything that is related to sensorineural hearing loss.
Click to expand...
Either way I think many questions will be answered for better or worse.
 
#2,334
Soren said:
Either way I think many questions will be answered for better or worse.
Click to expand...
I believe this should not worsen tinnitus. It should not. Treating tinnitus has been a complex thing for medicine because of oppositions, because of lack of interest in finding a cure.

We are creations of the Almighty, wisdom is on play here, there's a lot of information on tinnitus, what pathways are affected, what could be the possible root cause.

God can give revelation to a human for a cure.

I wonder how it was back in the days before LASIK existed.
 
#2,335
Soren said:
Either way I think many questions will be answered for better or worse.
Click to expand...
They could be answered much faster if the FDA cut the red tape and let Frequency Therapeutics conduct more congruent trials, and faster.

Why would they need 6-9 months to say, take preexisting audiograms, give drug, wait 3 months, take another audiogram? Ask, "did you have tinnitus?" and "did it get better"?
 
#2,336
@JohnAdams probably has something to do with the myelin. It could reestablish itself pretty well but without a sufficient signal, we wouldn't know how good it is. If they say it doesn't work now and that they need to tweak it then we'd all freak (even though that's what they are already doing). If they think strengthening the signal is worth it, then it is. They don't want to fuck up their first project because they didn't improve something they already know how to do.
 
#2,337
katri said:
@JohnAdams probably has something to do with the myelin. It could reestablish itself pretty well but without a sufficient signal, we wouldn't know how good it is. If they say it doesn't work now and that they need to tweak it then we'd all freak (even though that's what they are already doing). If they think strengthening the signal is worth it, then it is. They don't want to fuck up their first project because they didn't improve something they already know how to do.
Click to expand...

Let's say the drug works very well, and by December, they know this. The FDA is going to make them do another trial to discover something they may already know which will add another year to the entire process.

My idea is that if they figure out they have a slam dunk by December, then they should be allowed to skip the next trials.

We need to get some power players like the ATA, WWP, whatever to step in and advocate this.

This would speed up the release of the drug and make it cost less as well.

When this trial concludes in December, and IF they know it works, then there is no point in making them go through 2 or more more trials to answer questions that they already know the answer to just because the FDA has their process to follow.
 
#2,338
Side note:
Double blind placebo controlled studies are designed to rule out bias as well as the placebo effect.

There is no way the placebo effect could possibly apply to regenerative medicine.

If that was true then you should be able to give a placebo to an amputee and their belief that the drug would work would cause them to regrow their missing limb, which would actually be awesome.

There is actually a good chance that what I am advocating for FX-322 is already the plan. I wouldn't be surprised, these arent stupid people. If it works, they too will want to get it to market and lower initial costs.

And if it works they certainly will be raising awareness so maybe I should just chill and be patient.
 
#2,339
1000 said:
Tinnitus is a major concern, believe it or not, they are aware.
Click to expand...
clint.gif
 
#2,340
JohnAdams said:
Let's say the drug works very well, and by December, they know this. The FDA is going to make them do another trial to discover something they may already know which will add another year to the entire process.

My idea is that if they figure out they have a slam dunk by December, then they should be allowed to skip the next trials.

We need to get some power players like the ATA, WWP, whatever to step in and advocate this.

This would speed up the release of the drug and make it cost less as well.

When this trial concludes in December, and IF they know it works, then there is no point in making them go through 2 or more more trials to answer questions that they already know the answer to just because the FDA has their process to follow.
Click to expand...
This would be the only way for the FX-322 to get in people's ears faster.

https://www.fda.gov/forpatients/approvals/fast/default.htm
 

Log in or register to get the full forum benefits!

Register

Register on Tinnitus Talk for free!

Register Now

Similar threads

N
Delix Therapeutics — Neuroplastogen for Hearing Loss
Replies
6
Views
3K
Research News
AverageJoe12
AverageJoe12
N
Hoba Therapeutics' HB-097 for Sensorineural Hearing Loss
Replies
2
Views
1K
Research News
Nick47
N
N
Amber Therapeutics — Brain Implants
Replies
0
Views
776
Research News
Nick47
N
LBE
Intratympanic Lidocaine as a Potent Remedy for Tinnitus in Sudden Sensorineural Hearing Loss
Replies
2
Views
692
Research News
LBE
LBE
I
From Hidden Hearing Loss to Supranormal Auditory Processing by Increasing Neurotrophin 3
Replies
3
Views
2K
Research News
sspencermo
sspencermo
Top Bottom
Back
Forums
Members
Donate
Menu