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Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
"- Based on the data reviewed early next year, Frequency Therapeutics will try to go for the designated breakthrough status with the FDA to fast track this drug if they are seeing the results they are looking for in the current study."
So they are officially looking at efficacy and not just safety in this trial?
Outcome measures from Clinical Trials:
So they are officially looking at efficacy and not just safety in this trial?
Outcome measures from Clinical Trials:
- Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: Day 15 ]
- Time-concentration profile of FX-322 in plasma [ Time Frame: Baseline, Day 1, Day 2 ]
Blood samples to be collected within the first 24 hours of dosing to measure drug concentration in the circulation.
Mild hearing loss and moderate hearing loss are part of the current criterion for their target group as it stands today, and these are the two groups they feel will both benefit from FX-322 if it works.
Lucchino's offhand comment about FX-322 potentially benefiting cochlear implant candidates with severe hearing loss is interesting to say the least. He has privileged information we don't, so a comment like this garners fair intrigue.
Wow! Thank you so much for explaining
I really hope it is all a success and we all benefit from FX-322!
From a quick scan of the internet I've found information which suggests drugs that get breakthrough status on average come to market 2 years quicker than regular review process.
If anyone is wondering.
If anyone is wondering.
Member- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
From a quick scan of the internet I've found information which suggests drugs that get breakthrough status on average come to market 2 years quicker than regular review process.
If anyone is wondering.
At the current phase they are in right now, what timeframe are we talking about until it could reach the market? 2020? 2021? I guess for non-Americans we can only get the drug if it's officially on the market.
If I have any supporting cells left... please stay alive!!
This is the million dollar question, I have no real idea.At the current phase they are in right now, what timeframe are we talking about until it could reach the market? 2020? 2021? I guess for non-Americans we can only get the drug if it's officially on the market.
If I have any supporting cells left... please stay alive!!
While shaving 2 years off the time frame is certainly a welcomed idea, it probably doesn't mean the drug will be in the market in 2 years.
My gut instinct tells me that 5 years is a reasonable guess and that's with fast track status and yes it sucks.
The thought of one day having silence will be enough for me though if they assure us that this is going to work. For me one of the hardest things about this condition is the life sentence.
If someone could give me a date in the future I'd be tinnitus free it would mean so much to me.
This is a life sentence with no parole.
My uneducated guess is that 2 years with fast-track is a reasonable timeframe.
Reasons:
The inner ear is isolated from the rest of the body. Drug goes in the ear and nowhere else (as tested in first study in Australia). Less chance of unwanted systemic interactions.
It only stays in the ear for a short time. Less risk of side effects.
Success or otherwise is easily and reliably measured. Simple hearing tests.
Disclaimer: I know as much as most people here (which is pretty much nothing).
Exactly, which means they are already going to know if it works soon. Which is what makes me so pissed off about the alleged need for more trials. The most they should need is 1 more.
If the government would just dump a ton of cash into this company and run multiple trials in parallel they could really speed things up. They owe it to us. How many soldiers got tinnitus from their service? How many people got tinnitus from drugs that the FDA approved? Really I'd speculate that the government is one of the leading causes of tinnitus in the first place.
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Coleoptere
Member
Well, they have to investigate if it is working and totally safe. What would your life look like when after an injection you turn 100% death in an ear? Maybe with a screaming tinnitus as a remainder? That you are desperate does not mean they have to accelerate their research.
Sure I hope it will be on the market soon as long as it is safe.
Unfortunately I think that a period of 5 years is reasonable. I hope to have "supporting cells" when it is available.
It is cruel. If I had not attended the show and my tinnitus had increased years later because of an accident or something, I would have had some therapeutic alternative (FX-322, neuromodulation, etc.) to reduce it.
At least, if my daughter or a loved one suffers an acoustic trauma within a few years they will be able to use some of these treatments, if they are approved.
One thing that raised my eyebrows is that he said 200 years ago people weren't shooting guns...
1803-1815
Napoleonic wars.
1776 American Revolution.
30 years war 1618-1648.
Siege of Constantinople 1453.
Alrighty then
1803-1815
Napoleonic wars.
1776 American Revolution.
30 years war 1618-1648.
Siege of Constantinople 1453.
Alrighty then
Maybe he meant automatic and machine guns. He could be drawing a comparison between outdated hearing aids and new approaches like FX-322.One thing that raised my eyebrows is that he said 200 years ago people weren't shooting guns...
1803-1815
Napoleonic wars.
View attachment 23980
1776 American Revolution.
View attachment 23981
30 years war 1618-1648.
View attachment 23982
Siege of Constantinople 1453.
View attachment 23983
Alrighty then
I personally hope that someone like Bam or jasonbourne (think that's his name) or Autumly or Markku or fishbone or Valeri or Christian78 (I think that's his name) or derpytia.
Anything could happen. It's all up in the air but it shows way more promise than it did back in 2016
I appreciate your sentiment but I feel like I should be among the very last on this site to get a cure. I'm still thinking we need to get loud about this.
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If you really want to fight for this, get the attention of major institutions for veterans.
https://www.military.com/benefits/v...us-is-number-one-disability-for-veterans.html
DoD is already in contact with Frequency Therapeutics as well.
https://en.wikipedia.org/wiki/List_of_veterans'_organizations#United_States
We have to do it all together in an organized method, with the people that run the tinnitus communities to also help.
Hello friends.
You guys keep mentioning your supporting cells and whether or not they're alive by the time treatment comes. I'm assuming that's where the hair cells regrow from.
How long do they stay alive for? I have a feeling the answer is somewhere in the 83 pages of this thread but I'd rather not comb through it.
Thanks.
You guys keep mentioning your supporting cells and whether or not they're alive by the time treatment comes. I'm assuming that's where the hair cells regrow from.
How long do they stay alive for? I have a feeling the answer is somewhere in the 83 pages of this thread but I'd rather not comb through it.
Thanks.
Tinnitus in most cases is more than likely caused by hearing loss. The sound you're hearing is probably your brain filling in for lost input. Restoring hearing should reverse that. This is a profound experiment which will answer this question.
Never thought of that... I wonder if hair cells grow off of supporting cells..? So, we may or not have enough supporting cells to be able to recuperate our hearing?
FX-322 divides supporting cells so when the hair cell grows you don't deplete supporting cells.
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