Carl LeBel said that they didn't believe that was a factor for their drug.I remember reading somewhere, though not sure if true, that 20% if people have bad round window permeability. Maybe someone more knowledgeable can opine.
Carl LeBel said that they didn't believe that was a factor for their drug.I remember reading somewhere, though not sure if true, that 20% if people have bad round window permeability. Maybe someone more knowledgeable can opine.
Off the top of my head:Can somebody explain to me why FX-322 would work for some but not for others (outside of hair cell death, same level of expertise of doctor injecting it etc)?
Or should it work for everyone?
When Frequency Therapeutics did their perilymph analysis study earlier this year, they stated that anatomical factors did not affect drug delivery: "The presence of round window membrane mucosal folds in certain subjects did not prevent the entry of FX-322 into the cochlea"I remember reading somewhere, though not sure if true, that 20% if people have bad round window permeability. Maybe someone more knowledgeable can opine.
I actually think that your point about taking doctor's views as fact being a thing of the past is rather relevant, especially when you look at the way things are going in the medical field. From what I can see, the biomedical researchers actually seem to be much further ahead in the treatment space than the vast majority of doctors. Furthermore those working in the research field have far more knowledge around treatment options, what treatments would work and how to look at developing new treatments than the doctors do. It actually amazes me how clueless some doctors are when it comes to either knowing what treatments to prescribe people, how to look at developing treatments and also what is being worked on for future treatments.Taking doctor's views as fact is so 20th century
Thanks for the reassurance. I was just going to say that people seem a lot more skeptical ever since Frequency Therapeutics put out that update. Maybe it's natural for people to hyper-analyze any little update Frequency Therapeutics puts out since they're so few and far in between.
Is number 5 just related to tinnitus? I presume it is. Lucky, my hearing loss is just as big a concern, if not more so, than my tinnitus at present.Off the top of my head:
1) they have other untreated pathology that is more significant and possibly even undiagnosed (e.g. Hydrops, third window syndromes both are notorious for being hard to diagnose).
2) they didn't follow instructions and moved too much and/or swallowed after injection.
3) their injury is closer to the apex than where FX-322 reached.
4) they have an untreated immune or autoimmune pathology that makes the ear less conducive (this is theoretical but inflammation impairs that process in the intestine, so it makes sense).
5) they have a problem outside of their cochlear or one not addressed by hair cell regeneration (e.g. Neurotransmitter dysfunction after anti depressants, TMJ, ETD).
Even then most of these potential treatment barriers do not seem as if they are that difficult for people to overcome.Off the top of my head:
1) they have other untreated pathology that is more significant and possibly even undiagnosed (e.g. Hydrops, third window syndromes both are notorious for being hard to diagnose).
2) they didn't follow instructions and moved too much and/or swallowed after injection.
3) their injury is closer to the apex than where FX-322 reached.
4) they have an untreated immune or autoimmune pathology that makes the ear less conducive (this is theoretical but inflammation impairs that process in the intestine, so it makes sense).
5) they have a problem outside of their cochlear or one not addressed by hair cell regeneration (e.g. Neurotransmitter dysfunction after anti depressants, TMJ, ETD).
Re: number 4, I wasn't thinking of run of the mill inflammation here. I wouldn't think this would be necessary for most people without autoimmune conditions (and they might be fine too but I could see it being a potential hypothetical factor in terms of maximum efficacy).Is number 5 just related to tinnitus? I presume it is. Lucky, my hearing loss is just as big a concern, if not more so, than my tinnitus at present.
In relation to 4, would it then be a good idea to lower inflammation as much as possible before trying FX-322, i.e. using Astaxanthin etc?
I agree with the TMJ issue. I have had conductive issues/short bouts of tinnitus on the left side that directly stemmed from moving the mouth.Re: number 4, I wasn't thinking of run of the mill inflammation here. I wouldn't think this would be necessary for most people without autoimmune conditions (and they might be fine too but I could see it being a potential hypothetical factor in terms of maximum efficacy).
Re: number 5. You can get hearing loss or I should say hearing interference which can show up on an audiogram with TMJ (which improves with treatment):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3117795/
Tommyd87 what is your background? You seem to be very knowledgeable?I agree with the TMJ issue. I have had conductive issues/short bouts of tinnitus on the left side that directly stemmed from moving the mouth.
In terms of work and/or study, I have nothing to do with this area at all.Tommyd87 what is your background? You seem to be very knowledgeable?
I remember reading somewhere, though not sure if true, that 20% if people have bad round window permeability. Maybe someone more knowledgeable can opine.
I wonder how anyone who's had the Silverstein surgery fits into this. I know it's apparently reversible but even if the reinforcement can be removed, could it leave the round window in a non-permeable state? (Scar tissue etc.?)Carl LeBel said that they didn't believe that was a factor for their drug.
The comparison of the advent of LASIK and the eye care industry at the time with what we are likely to see with the potential success of FX-322 and the hearing aid industry, I believe, is limited to similarities in economics only and it stops there. Hearing loss and tinnitus, unlike poor vision, carries with it a rather latent prognosis for mental depression, dementia, and social isolation for many people - despair leads to suicide when there is no hope in sight.1. I absolutely agree about FX-322 working effectively but currently not going deep enough in the ear. I think that there is a lot more confidence with the stability and durability of the treatment results and benefits now that we have seen these outcomes. I think this is why the drug delivery methodology is going to be the major focus from Frequency Therapeutics in the near future. Finding ways to improve the drug delivery is seemingly the missing link and this will improve not only the benefit provided by FX-322 but also increase the number of people who can be assisted by taking FX-322.
At this point in time, I can clearly see that either the companies making these ear medicines like Frequency Therapeutics or drug delivery companies will initiate work to improve the dosing. It is obviously in the interests of the medicine development companies like Frequency Therapeutics to improve the effectiveness of delivery as this will mean it is possible to treat a wider group. However if a drug delivery company or companies can come out with improved techniques then they can provide this to all companies who are manufacturing ear medicines. This is a highly positive situation, as drug delivery companies now have a potentially highly profitable market to work with. Thus there will be huge interest in this project from the drug delivery sector and drug delivery companies and I am sure that we will see significant work take place. Pretty sure we have already seen the foundations laid for this type of work with the investigations and research into dosing via cochlear pumping techniques and that there will be more of this type of research continuing.
2. Your position that word scores fell due to a worsening at some lower frequencies is probably a fair summation. However I would also wonder whether there was some other factor at play. I would probably wait to see some further results to confirm that worsening at the lower frequencies was the cause. This is because while this is a likely cause, there are still some unknowns around the actual benefits of FX-322 and also there has only been limited testing done to date.
3. The fact that the benefits of the FX-322 have been maintained 20 months after administering it tells me that this further demonstrates that the FX-322's performance appears to be legitimate and that the benefit is real. Furthermore it shows that this progenitor cell activation process is an effective and legitimate technique. I agree with you that this is huge and also a major breakthrough. This shows me that the process does work and makes me feel very confident.
4. The LASIK comparison is highly relevant when it comes to looking at FX-322 and the views that some bodies and some individuals have towards it. While some entities have been balanced in their commentary about FX-322 and its performance and capabilities, there have been other entities who have been reasonably keen to be negative/critical of FX-322 too.
Based off of the information I have found out about when LASIK started in Australia, it seems that some in the eye care industry were very focused and keen on using whatever information they could to paint LASIK in a negative light. This didn't just include plausible and valid negative information (such as the cost of the treatment) but also groups were widely interested in using positive outcomes from early treatment using LASIK to try and show why it was not necessarily a good choice of treatment. We have also seen these tactics used by those who are against and are critical of FX-322.
I think that this is going to be a likely tactic used by groups like hearing aid manufacturers. The issue in Australia was that glasses used to be expensive and cost $400 a pair in mid 90s and actually now cost $99 for a reasonably good pair at the big brand/chain glasses stores. Optometrists were never going to admit this, though it is blatantly obvious that their criticism and concerns about LASIK were financially driven.
I can see this also playing out with hearing aid manufacturers, as they will have their business potentially reduced if treatment like FX-322 means that fewer people are using the hearing aids and/or people are only needing to utilise the basic devices.
In the end however, LASIK won out and became a highly viable option/alternative to glasses once it could be demonstrated the effectiveness and safety of the LASIK procedure was to a high standard.
I believe that the companies undertaking FX-322 and related treatments will simply have to go hard on the messaging and the information campaigning. My memories of watching TV as a child were that there were LASIK ads bombarding the TV to inform people of this option. The end result was that they helped to build up the knowledge of the procedure and thus candidates were willing to have the procedure. This meant others could now have first hand accounts of the procedure (such as what I was like and how it went) from others. This in turn then meant more people took up LASIK because if they previously had concerns these were being alleviated by the evidence from the procedure outcomes.
Thus I can see all regenerative treatments needing to follow the same path because not only are they going to need to educate people on the potential benefits of this treatment but this is also the most effective way to negate the resistance from the status quo.
5. I know that Frequency Therapeutics need to remain rather guarded and cautious when it comes to what information they release so they don't infringe the FDA/stock market rules, however I actually think that the fact that they have released some small unofficial hints about the benefits of the treatment and what is going on is promising progress and also going to make people feel more confident. I am pretty positive that the cryptic clues that Frequency Therapeutics has released about FX-322 give us a good insight in to what FX-322 can potentially do and also what Frequency Therapeutics will be doing in the future.
6. Although we don't know what is happening internally, I must say that that the decision to expand the scope of the operations to look at some other treatment groups for example definitely suggests some positive progress is being made and also that Frequency Therapeutics is robust. Right now I think that this is a good sign of progress.
Why does this worry you? It was a trial primarily designed for safety. Phase 2a will allow them to see what effect multiple dosing has.What's the reason only 4/13 participants saw significant improvements? Makes me a bit worried...
Carl LeBel reported that some patients involved in the trial had mentioned improvements in their tinnitus.So FX-322 hasn't done anything to people's tinnitus yet?
And alas there will be little else to hang our hats on until their testing proceeds.Carl LeBel reported that some patients involved in the trial had mentioned improvements in their tinnitus.
That would be crazy. I wonder if anyone in the trial lurks on this thread but can't comment because of the NDA. There already exists a yes or no to the million-dollar question, but for now, it's Schrodinger's cure.When things will really heat up is if/when someone who claims to have been through the treatment reports in here and subjects him/herself to interrogation.
Except we already know from Phase I/II that it does work in humans. The questions are: how will repeated doses help, how tinnitus will be affected, and if study adjustments will lead to a better outcome (everyone getting the high dose, everyone having moderate to moderately severe hearing loss, extended audiogram, etc).That would be crazy. I wonder if anyone in the trial lurks on this thread but can't comment because of the NDA. There already exists a yes or no to the million-dollar question, but for now, it's Schrodinger's cure.
In the group of 13 participants, does it also include those who received placebo?What's the reason only 4/13 participants saw significant improvements? Makes me a bit worried...
Right, I meant with regards to tinnitus rather than hearing loss.Except we already know from Phase I/II that it does work in humans. The questions are: how will repeated doses help, how tinnitus will be affected, and if study adjustments will lead to a better outcome (everyone getting the high dose, everyone having moderate to moderately severe hearing loss, extended audiogram, etc).
Right now they need to keep testing and see if they can achieve better results than what they currently have. They need to use extended audiograms to see how much it helped in frequencies above 8 kHz. People have speculated in previous threads with more information but right now if your tinnitus is located right within 8 kHz-16 kHz and your hearing only dropped 10 dB to 20db, I'd say your chances are pretty good of FX-322 being a cure. For everyone else they need to keep testing...Right, I meant with regards to tinnitus rather than hearing loss.
Maybe Otonomy would be open to the idea, since Otonomy was founded by Jay Lichter who has Meniere's & hearing loss with the aim to develop therapies for the inner ear. So maybe he would welcome any advance in the field.If OTO-413 shows that it improves hearing in the lower frequencies, I wonder if Frequency Therapeutics will attempt to license their hydro-gel - and if Otonomy would even be open to the idea, since they're developing their own hair cell regeneration drug.
There are three things I would say in relation to your post:And alas there will be little else to hang our hats on until their testing proceeds.
I mean, I do follow this thread because of the collapse of hope surrounding Lenire but it's still too early to develop any conclusions.
When things will really heat up is if/when someone who claims to have been through the treatment reports in here and subjects him/herself to interrogation. But that is pretty far away.
What I can say is that Frequency Therapeutics seems professional and doesn't have the same baggage of failure that Neuromod does. And while they haven't initially targeted tinnitus with this, they seem to be angling to make it a #2 priority. I'm just not picking up any red flags.
No this is only those who were dosed with FX-322.In the group of 13 participants, does it also include those who received placebo?
There's two things that I would point out about this post from a factual benefit.Right now they need to keep testing and see if they can achieve better results than what they currently have. They need to use extended audiograms to see how much it helped in frequencies above 8 kHz. People have speculated in previous threads with more information but right now if your tinnitus is located right within 8 kHz-16 kHz and your hearing only dropped 10 dB to 20db, I'd say your chances are pretty good of FX-322 being a cure. For everyone else they need to keep testing...
I frequently see a need on here to localize tinnitus to one structure in the cochlea. This is wrong. If it was just synapses, hydrops alone would not cause fluctuating tinnitus depending on severity (and it does). Same with middle ear disease, ETD etc etc.There's two things that I would point out about this post from a factual benefit.
1. There is still much debate about tinnitus being caused by very high frequency hearing loss. Many experts have actually identified that the tinnitus is much more likely to have been caused by hearing deficiency in the 250 Hz-8000 Hz range solely because this is where the vast majority of day to day sounds are located.
Furthermore, there is evidence which supports this such as the fact that the tinnitus can quite often be eliminated while using a hearing aid. At this stage most hearing aids do not go above 8000 Hz.
Also there are suggestions that tinnitus might be caused by damaged synapses and not hair cells.
There are three facts which support synapses being a potential cause of tinnitus:
- FX-322 is believed to restore synapse connections in conjunction with hair cells. There are also anecdotal accounts that FX-322 helped with tinnitus.
- The tinnitus treating Hough Ear Institute Pill is also assisting with synapse repair as well as supposedly being able to also treat tinnitus.
- There are people who have hearing loss but no tinnitus. This tends to be a fairly plausible indication that the synapses may play a bigger role in causing tinnitus than what people think they actually do.
Thus I am actually reckoning that while we might see benefit with tinnitus from using FX-322, we might actually see bigger benefit from treatments that target primarily synapses. This is because FX-322 is believed to not target synapses as effectively as a specific synapse treatment would.
2. Your theory about FX-322 being a cure for a 20 dB drop in 8000 Hz-16000 Hz is relatively realistic, even if it is not proven as of yet. However I don't necessarily agree that better testing is necessarily the answer to seeing if Frequency Therapeutics can get better results, but rather a better delivery method for FX-322 is.
There is already evidence that FX-322 works within the full range of hearing in the lab setting and thus it is just a matter of getting FX-322 much deeper in the ear to make it work more effectively.