MemberI hope when Phase 2a clinical trials for FX-322 are done that they can release it ASAP with Breakthrough Therapy status. I'm sick of waiting when I could be cured right now.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
TrevorSanders
Member
- Oct 8, 2020
- 85
- Tinnitus Since
- 09/2020
- Cause of Tinnitus
- Noise Exposure/Ototoxic Medication
These kinds of things keep me going.
Holy shit. This must be someone who got 4 shots of FX-322.
frpp
Member
- Sep 17, 2020
- 196
- Tinnitus Since
- 2010
- Cause of Tinnitus
- Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
Now that's hope right there!!!!! Whoever that was brave enough to violate their NDA I salute you and hope your hearing continues to improve.
Hopefully Breakthrough Therapy status incoming this summer.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
This is great and heartening to hear but surely this person is breaking their NDA and therefore potentially compromising the results of the trial?
The directionality aspect is amazing to hear and doesn't get talked about much. I hugely have this problem.
I'm glad to see this but I really am not fond of low info anecdotes, personally.
But then again, having someone come on with before and after audiograms and medical history (as well as how long it's been since the injections) would give too much identifying information.
Who knows how many they have had however. It could have been they have only had two for all we know. I will wait and see what the outcomes are in July when everything is unraveled.
Yes, sadly. I shall simply hope they end up doing the right thing and remove it.
frpp
Member
- Sep 17, 2020
- 196
- Tinnitus Since
- 2010
- Cause of Tinnitus
- Tmj, Nihl, ototoxic drugs, nerve/ vascular issues
Can't wait for good hearing, normal sound tolerance and silence. It's been far too long but the journey's almost over.
It would be freaking awesome if they got great improvement just from 2 shots of FX-322, hell even one. I'm hoping FX-322 restores everything or damn near everything and we never have to hear this hellish ringing ever again.
Holy shit. That's truly groundbreaking to hear.
Is this some private Facebook group? Are they technically violating the NDA?
Makes me very, very excited regardless. Big things in store for 2021, folks. A cure is coming.
We still have no clue how many shots of FX-322 the anecdote got. If he only got two shots of FX-322, that is a good improvement.
The fucking cure is near us now.
Wish they could've asked if they had tinnitus and how it was affected. I'm sure volume measurably reduced if they had that big of an improvement.
- Apr 23, 2019
- 364
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Slap to the ear / Leading to more issues after ear surgery
Yes they would be in violation of their NDA. But I wish it to be true... If they licensed this anywhere else in the world before USA, I would be there the next day if the results are positive.
We don't know yet. If they improve the dosing method to penetrate deeper into the cochlea then yes. The hope is that they can restore the whole frequency range from 20-20 kHz. Sadly it's all just speculation right now.
- May 2, 2020
- 202
- Tinnitus Since
- 01/2019 T, 04/2020 H
- Cause of Tinnitus
- Headphones/Car Alarm/Immune Response?
There's a long way to go before we know if this drug will help people with no discernible hearing loss. I'm glad to see this anecdote but don't jump off a cliff if this doesn't turn out to be a panacea, there is more research in the pipeline.
How does breaking an NDA compromise the results of a trial? I'm not advocating breaking an NDA, I just don't understand.
That said, we have no proof that person's even in a trial, or even exists.
THAT said, after 400 pages, it's nice to have another jolt of positive news, even if it's unverifiable hearsay.
Leaving aside the ethics and legalities...
1) Would researchers tell participants their specific results midway through a trial?
2) High frequencies seem more important than low frequencies in sound localisation, which would fit in with what we know about FX-322.
Does anyone recall how many extra frequency 'bands' were added to the phase 2a trial?
1) Would researchers tell participants their specific results midway through a trial?
2) High frequencies seem more important than low frequencies in sound localisation, which would fit in with what we know about FX-322.
Does anyone recall how many extra frequency 'bands' were added to the phase 2a trial?
Frequency Therapeutics probably won't be the silver bullet we're all hoping for, but it should undo a considerable amount of damage--even for noxacusis sufferers.
I agree with @FGG on this; anecdotal and unverified claims of results should be taken with a grain of salt. Naturally, I understand the excitement of this individual over their results and their inherent desire to broadcast them to the world, but I personally find it difficult to trust the validity of someone who violates a non-disclosure of something that could potentially change their life for the better and risk either their participation and or the overall trials.
We need to wait until the official results are presented in March before any real celebration.
We need to wait until the official results are presented in March before any real celebration.
Well what could possibly have happened is that they went to get a hearing test done themselves that is independent from the trial. The thing that we know is they were testing from 16 kHz, however it is incredibly possible if they got a hearing test done using the standard testing method then they wouldn't have been tested above 8 kHz.
False and misleading statements or claims could be made about the benefit of FX-322 from the illegitimate and unverified claims.How does breaking an NDA compromise the results of a trial? I'm not advocating breaking an NDA, I just don't understand.
That said, we have no proof that person's even in a trial, or even exists.
THAT said, after 400 pages, it's nice to have another jolt of positive news, even if it's unverifiable hearsay.
It only treats the high frequencies based off of the data we have seen thus far. What we were told however is that Frequency Therapeutics achieved compete regrowth in lab work. What this implies is it is possible to do the same thing in human ears, however whether this happens might come down to other factors like drug dosing or delivery to get it deep enough to where it needs to go to benefit lower frequencies.
This won't be the silver bullet basically because it cannot resolve everything on its own anyhow. All the research is confirming that we will need a synapse treatment in conjunction with a hair cell treatment to get full regrowth and thus full benefit.
I honestly don't care if they broke their NDA if it's an accurate and truthful account. They are not going to placebo their fellow participants into hearing better by broadcasting positive news.
The only threat is if they are an outlier in terms of their response to the therapy.
The only threat is if they are an outlier in terms of their response to the therapy.
Koz
Member
- Dec 15, 2013
- 153
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Unilateral sensorineural hearing loss
3 frequency bands is a fucking big deal. That's almost half of what shows up on the traditional audiogram. I just wonder how much these increases were in terms of decibels.
Please sweet baby Jesus let this be true.
Please sweet baby Jesus let this be true.
You have tremendous faith in the intellectual foresight of people. Could very well be someone who got too excited and didn't think it through.
I thought this drug also regrew synapses alongside the new hair cells though? I know it won't regrow damaged synapses for healthy pre-existing hair cells.
Isn't the test double-blinded? That would require different audiologists doing the hearing tests without comparing previous results. You raise a good point in that they would not be able to communicate with the patient about this.
Maybe this person did an online hearing test? When done with the same gear and headphones, they can be quite accurate I found.
This is one of the more interesting aspects of this trial to me. I really hope the four shots makes a difference compared to two. If that is indeed the case, the treatment could probably be extended for some (once released) to give maximum benefit.
Depending on age, genetics and amount of hearing loss, some people might just need 1-2 shots, while others might need 5-10.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
1. An Outcomes Assessor can tell the participant the outcome of their follow-up test. Both are still blind to whether the participant got 1/2/4 doses or placebo.
2. Good point.
3. I assume by bands they mean the audiogram. Could be 4 kHz, 6 kHz, 8 kHz on the standard, or if they're including the high-frequency, 8 kHz, 12 kHz, 16 kHz.
I would further speculate that they mean 4 kHz, 6 kHz, and 8 kHz band improvements; because "bands" are typically used in reference to the standard audiogram.
What about their tinnitus?
Wherever you found that, can you ask the person please?
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