Frequency Therapeutics — Hearing Loss Regeneration

Yep.

 

I am a bit sceptical about the line of reasoning regarding slide one, even though I very much wish you were right.

First, the figure does not indicate which region of the cochlea (i.e. which frequency region) is shown in the histological section on the right - thus, if the histological section shows lower frequency parts of the cochlea where hearing loss according to the left hand side of the slide is only moderate, there is no solid ground for arguing that severe hearing loss can be treated since in the high frequency area of the cochlea, all supporting cells could theoretically be dead. The pic does not tell.

More importantly, while supporting cells are present, it could be too few for the Frequency Thx approach to work, even if the shown histological section is from the high frequency area of the cochlea. Again, the figure does not provide enough information on this point. But let's hope the best...

 

I think it’s best to let the results do the talking at this point. Sorta seems a lot being said is speculation in my opinion

 

What I wondered about is the number of progenitor cells in the outer hair cell region.
In images I see, where these progenitor cells are shown, there are way less progenitor cells close to outer hair-cell regions.

 

This is concerning because outer hair cell damage plays a role in painful hyperacusis.

 

As far as I know this is not certain. It is still not known what exactly happens with hyperacusis with pain.
Also, what do I know regarding progenitor cells (-; Perhaps this observation of me is completely wrong.

 

I don't know either but the researchers are saying painful hyperacusis has something to do with outer hair cell death/damage and a small subsection of nerve fibres associated with them.

The problem is scientist are mostly saying it has to do with outer hair cell damage, meaning the outer hair cells are still alive but weak and their nerve fiber acting as pain receptors. Frequency will grow new hair cells not repair the damaged ones. I don't know if this will help painful hyperacusis, but hoping.

 

So, with this drug infusion, the progenitor cells would be smart enough to know which hairs to regrow? Because aren't the hairs in the cochlea lined up according to frequency? Or would they just grow all new hairs, period?

 

@Street Novelist Thats a good question. I imagine they would be all new if the other hair cells have had some damage done by noise exposure.

 

That is where concern comes it on how well regulated the hair cell regeneration will be.
We won't know the answer until stage 2 clinical trials of if Frequency gives us a direct update.

Hair cells will not grow if progeintor cells do not exist in the area. How much we don't know but that's why mild/moderate hearing loss will be the ones getting theraputic help and severe/profound hearing loss will unfortunately not much if this works.

 

Does anyone know when phase 2 is supposed to start?

 

I've heard conflicting reports, but I recently heard that they are suppose to start in the summer of 2018, and since it'll go on for 18 months, the results will probably be out by early 2020 at the very least.

 

How can I be a part of the next clinical trial? I developed sudden sensorineural hearing loss overnight in one hear from exposure to loud music. The audiologist says it's mild but I have horrible tinnitus as a result (mainly clicking and popping in both ears). I would do anything to be a part of the next phase.

 

There definition of mild hearing loss is very noticeable with a dip around 4-8k and higher frequencies above being very poor. Hearing loss begins way before it cuts into the human voice range without background noise. But most audiologist do not acknowledge the damage until the human voice range is affected.

 

Sorry if this has been answered elsewhere but Stage 1 is simply a test to make sure the drug doesn't kill the person they administer it to or harm them in some way? Stage 2 would be testing the effectiveness of the drug and if it shows any improvement? Then what would Stage 3 be, long-term effects? So realistically we could see this drug out anytime from 2020 to 2025? I''m also quite curious how someone who willingly underwent the procedure hasn't giving a testimony yet, surely if the drug had a profound effect even in stage 1 their would be a testimony posted somewhere.

 

Stage one tested profound hearing loss (virtual deafness) just for safety.

Frequency Therapeutics admitted that their product will not hardly do anything in full deafness due to the progenitor cells used to restore hearing being dead.

At first I was very confused about that.

 

How can someone be in their next clinical trial? I've left emails and voicemails for Richard Mitrano, but no response. Does anyone know?

 

Also all Phase I participants underwent cochlear implant surgery shortly (a few days?) after the injections, something that totally alters the hearing equation and precludes evaluation of treatment efficacy.
(Incidentally I assume they chose such patients because they wanted to confirm the presence of the serum in the cochlea following a given time period; this presumably requires physical access to the cochlea, and those patients were going to have their cochlea exposed anyway for their implant surgery. But, that's just a guess.)

 

I still think its too early to say that severe to profound patients have no chance for cure concerning this therapy. I still hope this works for everyone. If you had severe to profound hidden hearing loss...you cant tell so at this point everyone with Tinnitus has to fear that she/he has severe to profound hidden hearing loss. Lets stay cool until we get some data or at least the information that it works in human ears.

What I understand right now is that it only could work until moderate measured noise induced hearing loss - that means your audiogram should show a hearing loss that goes maybe at 2khz to moderate and again up at 6khz to normal hearing and you must have noise induced hearing loss? Pretty unusual because most of hearing loss patients loose high frequencies first what you see right now in an audiogram is just a small part of the battle in your inner ear.

The problem I see here with hearing loss is always that we are still world wide in a knowledge stage where ENTs cant say you 100% what the root cause was and many of us are not sure because there are lots of possibilities. Before my hearing loss and Tinnitus appeared I didnt check my vital functions all the time - now I just hear my body screaming and cant stop listen to it.

Other root causes like stress, blood cirulation, antibiotics, neck vessels, diving/pressure, .... an endless list of possibilities and combinations. I cant find any information where they calculated supporting cells based on audiograms and root causes. That would be pretty interesting.

Concerning measuring high frequencies my ENT told me that the human ear hears pretty good between 1khz - 4khz and thats also easier to measure because the hearing level db HL is equal to the sound pressure level db SPL. All other frequencies need different handling to be measured. Specially higher frequencies need more pressure and that could lead to interferences or vibration. Wouldnt surprise me when I look at the physical wave of a high frequence tone. Even a complete deaf person could believe he hears something based on virbrations on the headphones that gives me the idea that our possibilities to measure those frequencies are limited or maybe not 100% correct.

 

No it's not too early, Frequency announced profound deafness had virtually no progenitor cells and they were too far gone to be therapeuticized.

Profound/Total Deaf people can't or can't hardly here anything. Usually extremely loud low freq noises. They may feel vibrations like you said. Once again ENT's across America do not value frequencies above 8k simply because their practice is outdated and only concerned with human voice range. Music, birds chirping, and crickets at night that go above 8k are not valued.

 

I don’t think this is a exactly right. First of all, Frequency didn’t announce anything officially/that definitive yet but a guy on reddit said something of the kind from what I understood. And even though it appears to be partially true that some people suffering from profound deafness do not have supporting cells it is not certain that every person suffering from this condition lack of supporting cells.

Just take the CgfF166 and ATOH1 ongoing experiment: there are typically looking for people suffering from severe to profound deafness (below 110 dB in high frequencies from what I read on clinical trials). How could you then assume that people with profound deafness lack of supporting cells, considering that the ATOH1 is suppose to convert supporting cells into hearing cells? (Main difference with Fx 322 which ‘activates’ supporting cells without converting them into hearing cells).

Plus the only way to verify the statement that people with profound deafness lack of supporting cells would be to perform an autopsy on them and analyse their inner ear which I am not sure was often performed (maybe on mice).

I assume some people with severe to profound deafness do not even have supporting cells but others do, otherwise the cgf166 trials guys wouldn’t bother testing their gene therapy on them.

 

Frequency is not a gene therapy like those guys.

It's using something thats a lot less expensive, a lot more effective and works with the bodies native biology called
Progenitor cell activation (PCA) . At this moment in time gene therapy is showing to be less effective then PCA or atleast what Frequency is claiming.

I am making an edgy assumption that if gene therapy became the first to pass a clinical trial that no one but the very wealthy for the next several years would be able afford it, and it would be minimal hair cell regeneration and hearing aids would stay as a monopoly.

Where as PCA activation uses the bodies own native biology with simple drugs that do the exact same thing intestinial progenitor cells do naturally but in the cochlea for hair cell regeneration. Frequency also duplicates progenitor cells before converting them. Clearly F-tx's method is superior to gene therapy on every level, maybe in the future gene therapy can be perfected but as of now it's in it's infancy and it would be a shame to see an extremely expensive half ass treatment for hearing loss that loses to hearing aids, (but atleast better then nothing)

 

Wait. Am I reading this right? FX-322 also increases the amount of progenitor cells in your ears? So, theoretically, this would also increase the chance of regaining full hearing, correct?

 

yes but in profound hearing loss there is virtually no progeintor cells to begin with.

Hearing loss also comes from synapse damage from existing damaged hair cells that will not be repaired as well damage to the auditory nerve itself. This science is really promising but not perfection.

I being someone with mild hearing loss am looking forward too hearing normal again

 

So are the synapses what transmits the signal to the brain? So even if the hair is regrown they are technically unplugged unless the synapses can reconnect, so long as the connection isn't made the ringing would still be around since the brain still isn't receiving?

 

yup, it's like an unplugged cord, or a damage to the synapses causes muffled hearing in complex listening enviorments.

let's talk about this somewhere else. i feel like an idiot to making this thread off topic
There needs to be a faq tab pinned that answers the basic questions and updates that aaron123 has already answered and better then i have. We need to keep this thread organized and free from off topic shitposting ironically what i am doing right now

 

How can you just make such an assumption and sell it as a fact, people may believe you! As far as I know, we have one statement on Reddit: "If supporting cells die, the epithelium is practically gone, and this would present as profound hearing loss." This is a statement of the Form "if A happens, then B applies". So if, supporting cells die, this presents as profound hearing loss. You cannot assume "from B follows A" from that. You cannot just say, if you have profound hearing loss, you have no supporting cells. Thats it, stop spreading misinformation please.

Here's the post which contains the reddit quote: Frequency Therapeutics — Hearing Loss Regeneration

 

I have a question on "Virtually no supporting cells for profoud hearing loss". I have normal hearing ability till 1500HZ( 5 db to 15db).. and then profound in 2000 - 6000 HZ. I have severe in 8K plus. But bone conduction tests shows that I have severe hearing loss from 2k to 6K as well. Also with my hearing aid, I can hear till 60db in 2k to 6k( Not sure how is this possible if no supporting cells to boost, but happens !) . This is bilateral sensorineural acquired hearing loss. Do you think i may benefit from FX322 ? If so, as per your theory, my 8K may go upto moderate or mild and 2k to 6k may not be benefited. Is that right? Also wondering what kind of candidates to qualify on Trial 2, where you Freq Therapetius wants to study efficacy on all sorts of hearing loss. There might be candidates who have complicated audiogram like me too.

 

Might be, might not. All speculation at this moment. The only source for the supporting cells is a quote from reddit. I don't even think it's known where the trials will be held and what criteria they hold. Note that for the first trial it were patient undergoing surgery for a cochlear implant.
Let's hope it indeed does what you describe, but for now unfortunately only time can tell..

 

When in God's name is the next phase going to start? What's the holdup?