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Frequency Therapeutics — Hearing Loss Regeneration

#4,801
Call me desperate, but I sent them an email... Let's see!

"Hi,
I developed some hearing loss in the 8000 + Hz range and as a result I have high pitched tinnitus that is distressing. I was wondering if your new drug (FX-322) would be a good option for me once it is available to the public? Also, are there any clinical trials for people in my position?
Thank you,
Alex"
 
#4,802
Guys, today I just thought that maybe we should do something to speed up the process and make this drug available faster somehow, and I have two ideas. Some feedback on them would be welcome.

1. I don't know how drug approval works in other countries, but there should be a damn country where this drug would be accepted with those preclinical studies + the Phase 1/2 study + the fact that it is used for chronic, debilitating conditions which have no other (drug) treatment options, and we understand the risks of using it and consent. Thus, maybe we should let Frequency Therapeutics alone and try to request Astellas to bring the drug on the markets of countries which would accept it, since they own the rights for the drug in ex-US*. I would go to the other side of the world to try it.

2. Make requests to the FDA and tell them that it is unethical to not let us try the drug in the aforementioned situation (it is worse to withhold the drug than it would be to let us use it).


* or just start a clinic on some unclaimed island and name it "The Hearing Restoration Island"
 
#4,803
John Queen said:
Guys, today I just thought that maybe we should do something to speed up the process and make this drug available faster somehow, and I have two ideas. Some feedback on them would be welcome.

1. I don't know how drug approval works in other countries, but there should be a damn country where this drug would be accepted with those preclinical studies + the Phase 1/2 study + the fact that it is used for chronic, debilitating conditions which have no other (drug) treatment options, and we understand the risks of using it and consent. Thus, maybe we should let Frequency Therapeutics alone and try to request Astellas to bring the drug on the markets of countries which would accept it, since they own the rights for the drug in ex-US*. I would go to the other side of the world to try it.

2. Make requests to the FDA and tell them that it is unethical to not let us try the drug in the aforementioned situation (it is worse to withhold the drug than it would be to let us use it).


* or just start a clinic on some unclaimed island and name it "The Hearing Restoration Island"
Click to expand...
I have heard rumors of people somehow getting ahold of experimental drugs from shady pharmacies in China (specifically one guy on Reddit claiming he did this with a hair loss pill) that copy these drugs. I don't know how that works nor how it can be guaranteed that the drugs are genuine. Plus anyone can claim anything on Reddit.

In the case of Frequency you would also have to know how to administer it properly.
 
#4,804
FGG said:
I have heard rumors of people somehow getting ahold of experimental drugs from shady pharmacies in China (specifically one guy on Reddit claiming he did this with a hair loss pill) that copy these drugs. I don't know how that works nor how it can be guaranteed that the drugs are genuine. Plus anyone can claim anything on Reddit.

In the case of Frequency you would also have to know how to administer it properly.
Click to expand...
It doesn't have to be shady.

https://www.sigmaaldrich.com/catalog/product/sigma/sml0506?lang=en&region=US

25 mg = $700. Way more than enough.
The only thing standing in the way is finding a competent person that can do eardrum injections and willing to despite the law.
 
#4,805
JohnAdams said:
It doesn't have to be shady.

https://www.sigmaaldrich.com/catalog/product/sigma/sml0506?lang=en&region=US

25 mg = $700. Way more than enough.
The only thing standing in the way is finding a competent person that can do eardrum injections and willing to despite the law.
Click to expand...
I doubt you will find a vet to do this. Practicing human medicine without a license is even more illegal for vets because of the public's understanding that they have similar medical training. Not to mention that the intratympanic injection probably has to be angled a specific way for proximity to the round window. I think you need an ENT to do this realistically unless it's not as precise as I imagine.

My hunch is your best bet is to find someone overseas.

Please wait until April, though. At least then you'd have a better idea of methods and dose. I think you are very brave but please be careful.
 
#4,807
JohnAdams said:
It doesn't have to be shady.

https://www.sigmaaldrich.com/catalog/product/sigma/sml0506?lang=en&region=US

25 mg = $700. Way more than enough.
The only thing standing in the way is finding a competent person that can do eardrum injections and willing to despite the law.
Click to expand...
I've tried to purchase from Sigma Aldrich before and they won't sell to the general public. You can put an item in your cart and pay but they will review the order and cancel it unless you are a company or a researcher.
 
#4,808
FGG said:
I would actually like to hear someone try this who has a confirmed normal audiogram up to 16000 Hz. I have severe to profound loss over 11000 Hz (and also some brain stem hearing issues) or i would try it.

What do you attribute the dramatic increase in word scores of those 4 who had moderate to severe loss while no placebo subject had the same response?

Whether or not my theory about ultra high frequency holds, it's clear the drug had an effect.
Click to expand...
There was no change in audiogram so according to Occam's razor the most obvious cause is something like bias. Bias is the intentional or unintentional adjustment in the design or conduct of a clinical trial that may affect the results. For example selection bias. The simplest solution is most likely the right one.

I have done word score tests and they are not that scientific and clear cut like an audiogram. So depending on your hearing curve if you are at the borderline you may "figure out" the test after some time. I don't know how they chose the patients in the groups but that could be one explanation.

If I was to look for more extraordinary explanations then I would guess the drug improved some frequencies within the speech range (let's say eg. 500-4000 Hz) and that improvement happened to take place within just narrow range between tested frequencies. Maybe it improved eg. between 3200 – 3500 Hz when they tested only 3000 Hz and 4000 Hz and so on.

I don't actually believe that they did not test up to 16000 Hz. This drug and its basic principles have been researched for a long time and a lot of money has been invested. Then comes the big day when this drug is finally injected into the ear. Would these highly qualified hearing specialists and professional scientist decide that we will only test it up to 8000 Hz? Would their investor agree that lets leave some stones unturned? No no no… That makes absolutely no sense. Testing from 8000 Hz to 16000 Hz adds no costs and takes about an additional minute to do.
 
#4,809
Mr Mister said:
There was no change in audiogram so according to Occam's razor the most obvious cause is something like bias. Bias is the intentional or unintentional adjustment in the design or conduct of a clinical trial that may affect the results. For example selection bias. The simplest solution is most likely the right one.

I have done word score tests and they are not that scientific and clear cut like an audiogram. So depending on your hearing curve if you are at the borderline you may "figure out" the test after some time. I don't know how they chose the patients in the groups but that could be one explanation.

If I was to look for more extraordinary explanations then I would guess the drug improved some frequencies within the speech range (let's say eg. 500-4000 Hz) and that improvement happened to take place within just narrow range between tested frequencies. Maybe it improved eg. between 3200 – 3500 Hz when they tested only 3000 Hz and 4000 Hz and so on.

I don't actually believe that they did not test up to 16000 Hz. This drug and its basic principles have been researched for a long time and a lot of money has been invested. Then comes the big day when this drug is finally injected into the ear. Would these highly qualified hearing specialists and professional scientist decide that we will only test it up to 8000 Hz? Would their investor agree that lets leave some stones unturned? No no no… That makes absolutely no sense. Testing from 8000 Hz to 16000 Hz adds no costs and takes about an additional minute to do.
Click to expand...
Disagree.
 
#4,810
Mr Mister said:
There was no change in audiogram so according to Occam's razor the most obvious cause is something like bias. Bias is the intentional or unintentional adjustment in the design or conduct of a clinical trial that may affect the results. For example selection bias. The simplest solution is most likely the right one.

I have done word score tests and they are not that scientific and clear cut like an audiogram. So depending on your hearing curve if you are at the borderline you may "figure out" the test after some time. I don't know how they chose the patients in the groups but that could be one explanation.

If I was to look for more extraordinary explanations then I would guess the drug improved some frequencies within the speech range (let's say eg. 500-4000 Hz) and that improvement happened to take place within just narrow range between tested frequencies. Maybe it improved eg. between 3200 – 3500 Hz when they tested only 3000 Hz and 4000 Hz and so on.

I don't actually believe that they did not test up to 16000 Hz. This drug and its basic principles have been researched for a long time and a lot of money has been invested. Then comes the big day when this drug is finally injected into the ear. Would these highly qualified hearing specialists and professional scientist decide that we will only test it up to 8000 Hz? Would their investor agree that lets leave some stones unturned? No no no… That makes absolutely no sense. Testing from 8000 Hz to 16000 Hz adds no costs and takes about an additional minute to do.
Click to expand...
Well then I guess you are smarter than the investors at Astellas Pharmaceuticals. A company with $14 billion in assets and an annual revenue of $11 billion. You know, because it is easy to get that successful by investing in things that don't work.
 
#4,814
Ringeee said:
Do any of the trials say that people with hidden hearing loss/hearing loss in general have had improvement in their tinnitus?
Click to expand...
Not so far because none of these regenerative drugs have completed beyond phase 1 yet. We should have that answer second half of next year.
 
#4,820
Mathieulh said:
I am afraid you can't even fake that
Click to expand...
The video mentions it is difficult, but it doesn't say you can't.

The video assumes that your friendly audiologist will put you through all the stages of test... PTA, PTA in noise, word recognition, reflex, OAE, ABR, which is not true: many audiologists will just do the first 3, which are, admittedly, difficult to fake (you have to be very consistent, and smart enough to know how a word will sound with a given loss you are faking, which you can "prepare for" since the word lists are standardized and you can apply a hearing loss filter to your audio output on your computer). Yes, that's a lot of work, not an easy task, and not something I'd recommend, but it doesn't sound impossible (the video doesn't say it is: it says it's quite difficult and that you have to be very consistent).

If you do go down the full testing path with reflexes/OAE/ABR that don't require patient signaling, then you'll have some explaining to do indeed. If that happens then I agree, you don't stand much of a chance.
 
#4,821
JohnAdams said:
Well then I guess you are smarter than the investors at Astellas Pharmaceuticals. A company with $14 billion in assets and an annual revenue of $11 billion. You know, because it is easy to get that successful by investing in things that don't work.
Click to expand...
You are convinced that having Astellas as an investor guarantees success in curing hearing loss :) You should definitely buy Frequency Therapeutics stock. Just beware that the general statistical probability through clinical trials to approval is around 10%.
 
#4,822
#4,823
Mr Mister said:
You are convinced that having Astellas as an investor guarantees success in curing hearing loss :) You should definitely buy Frequency Therapeutics stock. Just beware that the general statistical probability through clinical trials to approval is around 10%.
Click to expand...
No, I just think their opinion matters more than yours. This drug definitely regrows human hair cells. That's been proven. Regrowing hair cells improves hearing in mammals, something else that's been proven. This was a very small dose and they didn't seem to measure HF hearing. I think there is good reason to be very optimistic.
 
#4,824
JohnAdams said:
No, I just think their opinion matters more than yours. This drug definitely regrows human hair cells. That's been proven. Regrowing hair cells improves hearing in mammals, something else that's been proven. This was a very small dose and they didn't seem to measure HF hearing. I think there is good reason to be very optimistic.
Click to expand...
It is proven to grow hair cells of living mice but not living humans. Pre-money valuation of USD 425 million is very attractive if you believe it will work. There is huge upside if they can prove efficacy. On the other hand it is a bit disappointing that they don't see more value in the business currently. USD 425 million is nothing compared to the market opportunity for curing hearing loss.
 
#4,825
Mr Mister said:
It is proven to grow hair cells of living mice but not living humans.
Click to expand...
It regrew the hair cells in a human cochlea that was donated by a guy that was getting it removed to operate on a brain tumor and the guy was more than likely alive when they did that, his cochlea just wasn't in his head.

So......... you're wrong?
 
#4,826
Here's the truth.

These types of drugs work. They restore hearing. FACT. Restoring hearing will alleviate tinnitus and hyperacusis PROBABLY FACT. They are also kinda dangerous because they are messing with cellular signalling pathways that can trigger tumors and other stuff. FACT. As long as they don't get into the blood stream then they are okay. FACT. That is why phase 1 was measuring blood plasma levels.

Here's the doom scenario, and I am speaking from experience. An ENT is doing this procedure, and sticks the needle in a little too far and instead of injecting the gel into the middle ear cavity, they inject it into the middle ear epithelium. That will introduce the drug I to the bloodstream. BAD. It can happen. One time Minbo Shim did that to me with PRP, and it hurt so bad that I was cussing him out. It was up there in the most painful things I ever experienced, but that was 1 out of > 100. AND it was PRP so it was okay.

I 100% believe this is a full blown cure for many of us, but success depends on the steady hand of the ENT/Otolaryngologist doing the procedure and it could be the difference between life and death. And it will not be a one time shot, this will undoubtedly require multiple injections.

Make no mistake, this is some high wire medical shit that will require the ENT to be perfect with their hands. Despite the awesomeness of this technology, the major risks might sink this. Hope not. :)
 
#4,827
JohnAdams said:
It regrew the hair cells in a human cochlea that was donated by a guy that was getting it removed to operate on a brain tumor and the guy was more than likely alive when they did that, his cochlea just wasn't in his head.

So......... you're wrong?
Click to expand...
This is a good point he will likely dismiss but it is an important one: they regrew hairs in an intact cochlea with FX-322. This means the drug works and works on live human cells. There really is no other explanation for the regrown hairs. Astellas knows that too.

The only difference in the clinical setting would be penetrance into the cochlea through the round window. This means, at least at a smaller dose, it would only reach ultra high frequency areas.

I believe Frequency would have definitely measured an extended audiogram if they anticipated the results they got in the safety study. It's not very scientific to do an "after" measurement without a baseline "before" measurement and selecting participants based on ultra high frequency results for a safety study makes no sense. It would just delay the whole process just to repeat it again during phase 2. Phase 1 does not test for efficacy. It's not designed to.

The question about ultra high frequency hearing will definitely be answered at the conclusion of phase 2a in 2020. I think it's extremely pertinent that they are adding audiograms up to 16000 Hz and tinnitus scores to phase 2a. This tells me that something in phase 1 is prompting them to add these measurements to the experimental arm of the study. Occam's razor, you know?

They have some other piece of information we don't have: patient testimonials. While you can't declare those scientific, I do wonder if there had been comments about tinnitus reduction and that's why it was added to phase 2. Unless that was part of the study plan all along, it suggests some cautious optimism there too to me.
 
#4,828
JohnAdams said:
Here's the truth.

These types of drugs work. They restore hearing. FACT. Restoring hearing will alleviate tinnitus and hyperacusis PROBABLY FACT. They are also kinda dangerous because they are messing with cellular signalling pathways that can trigger tumors and other stuff. FACT. As long as they don't get into the blood stream then they are okay. FACT. That is why phase 1 was measuring blood plasma levels.

Here's the doom scenario, and I am speaking from experience. An ENT is doing this procedure, and sticks the needle in a little too far and instead of injecting the gel into the middle ear cavity, they inject it into the middle ear epithelium. That will introduce the drug I to the bloodstream. BAD. It can happen. One time Minbo Shim did that to me with PRP, and it hurt so bad that I was cussing him out. It was up there in the most painful things I ever experienced, but that was 1 out of > 100. AND it was PRP so it was okay.

I 100% believe this is a full blown cure for many of us, but success depends on the steady hand of the ENT/Otolaryngologist doing the procedure and it could be the difference between life and death. And it will not be a one time shot, this will undoubtedly require multiple injections.

Make no mistake, this is some high wire medical shit that will require the ENT to be perfect with their hands. Despite the awesomeness of this technology, the major risks might sink this. Hope not. :)
Click to expand...
Did Dr. Shim aspirate before injecting to make sure he didn't get a flash of blood? Seems like an easy way to prevent an intravascular injection but may not have been something he was overly concerned with using PRP.

Agree that you absolutely wouldn't want someone careless with that.
 
#4,829
#4,830
FGG said:
Did Dr. Shim aspirate before injecting to make sure he didn't get a flash of blood? Seems like an easy way to prevent an intravascular injection but may not have been something he was overly concerned with using PRP.

Agree that you absolutely wouldn't want someone careless with that.
Click to expand...
This could be a potential problem with inexperienced ENTs driving BMWs and having no hand on experience with intratympanic injections. When and if this drug is available, we will then have to search for skilled ENTs. I'd go to Silverstein in Florida, he's invented so many things already, but he's old and deserves to retire. Perhaps one of his protégés as long as he's not high on coke ...

One step at a time. Phase 2a coming soon. Let's jump that hurdle, fingers crossed.

Although I am reconciled to my condition, I still have hope and can dream for a brighter day. I am only human... I think.

So glad you are here FGG, and JohnAdams, you always brighten my day. Thanks.
 

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