Memberit would definitely inform me rather I should commit suicide or not knowing the results early on
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
The last thing we want is to have a participant in a trial break their confidentiality commitments. In addition to potentially important legal repercussions for him/her, it could have a deterrent effect on new developments and new trials with an increased (warranted) worry about leaks. It could also nullify the whole study (depending on what information is leaked and who gets access to it).
I am just as anxious as you for a cure, but encouraging these breaches is counterproductive and will work against our common goal.
the FDA has a really lame way of doing things. that's what I got from your statement, you are right about that.
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Thats where you are wrong. We can never know about it soon enough. Not for us Groundhogday-ers!
The best thing is to let the trial run it's course. When the phase II trial is complete we should be getting the results from that pretty soon. If this goes to phase III we basically know that the results from phase II had to be positive or else they wouldn't proceed with the much more expensive phase III.
Phendran
Member
I wish we already knew the results were positive when they passed phase 1. Feels weird to me how they could finish any phase at all if their drug does nothing.
Well, phase I is a test on healthy volonteers designed to see if the drug is dangerous to people and to find an optimal dose with regards to side-effects. Phase II is where they actually test the drug on intended target patients. This is where we are now.
Before any phase of a trial they have to prove both efficacy and safety on animals. So the drug does work on mice and guinea pigs at least.
https://en.m.wikipedia.org/wiki/Phases_of_clinical_research
If it's like the Regain trial, they may exclude participants where tinnitus is the primary problem. They may not want to muddy the waters. I think many of us here (myself included) are spending way too much time and emotional involvement on tracking/second-guessing/predicting this whole process. The healthiest thing to do right now, might be to back off a little and deal with our various issues as best we can in the present. If and when a treatment eventuates, I'm sure they won't keep it secret.
Generally Phase 2 can take anywhere from several months to 2 years, how long after it's completed will we get results is anyone's guess as we still haven't even seen any published results from Phase 1 as far as I'm aware, and that was completed back in December 2017. Phase 2 will officially test if there is an improvement so if we get to phase 3 expect 100% positive things to come sans any crazy complications like tumors forming from cell reproduction, although if it didn't happen in mice I doubt it would happen in humans.
If I had to venture a guess haircels would probably grow within a month if they behave anything like normal hair, besides the whole not regrowing thing. I doubt they would spend anything more then a year tbh studying the affects, it either works or it doesn't.
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Regarding:
https://www.alamoent.com/wp-content/uploads/2018/07/Hearing-Loss-Study.pdf
So, why would someone make this info-sheet of a study, using Frequency´s drug F-322, if it is just BS. I just do not get it!
https://www.alamoent.com/wp-content/uploads/2018/07/Hearing-Loss-Study.pdf
So, why would someone make this info-sheet of a study, using Frequency´s drug F-322, if it is just BS. I just do not get it!
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Thats the second thing that baffles me. Why does´nt anyone residing in the US or someone with good oral english skills call em to find out their legitimacy?
Like I´ve said, I wrote them an email, trying to get additional info. No reply!
Could you try and call them on Monday, @Flamingo1 ?
On one of the Facebook forums, there has been an active discussion and several people have been in contact regarding the clinical trial. Hopefully some people on Tinnitus Talk may do the same and report back. The rules of these forums do not permit sharing of information, so I will not link or copy anything, but based on what people said it all sounded perfectly legitimate. But will be good if any TTalk members are in contact and can report here, then we can learn more.
I dont understand why there arent people on this site with more involvement in any of these activities.
My question is: if fx 322 causes progenitor cells to grow, then wont fx 322 cause too many hair cells to grow and distort hearing perception?
I have called them. I am from Maine and willing to fly. The reason you might not get a response from the email that is on the flyer, is because the person is on vacation until August 1st. I called the phone number in which case on his voicemail he just says to call the ENT number. I have done that and they have been very responsive. They were just waiting for some doctor who is doing the study to also come back from vacation. He has now. My hearing loss is over 8khz. The receptionist still wants me to send the audiograms for the Dr to review to see if I qualify. I will be doing that soon and have the receptionists email to send them to. I am not going to ask lots of questions because I feel like too many things are unknown. If I get in, then great. If not I live near Boston and hopefully Decibal has something soon. I hope soon that everyone has a quiet night sleep.
My hearing loss is over 8000hz too and I'm worried that will be considered clinically insignificant. My Right ear has a big dip literally at 10,000hz but beginning at 6000hz in my right ear background noises + high pitches start to have less priority and muffle as you go higher, meets Liberman's description of hidden hearing loss exactly.
Yes but I'm not sure they're interested in people with hidden hearing loss at the moment. They have to get the drug approved and to do that it would be more reasonable to target people where it's easier to measure progress. Then when the drug is out on the market it could easily be used on people like you (and me) who have loss in the very high frequencies and/or hidden hearing loss.
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Hair cells in the cochlea have absolutely nothing to do with hair. It's just unfortunate naming due to their relative visual resemblance. But they are a completely different cell type.
It is easy to measure high frequency (greater than 8kHz) hearing restoration with a before and after audiogram. Whether ENTs are willing to do that is a different question. But that is laziness rather then any scientific roadblock.
If they deny me because mine is over 8khz or if they accept me I will let the community know. I have to get an updated audiogram for them in the next couple of weeks to go with my previous one from about a year ago.
I am also interested to see if they say no because one of my main medical complaints is tinnitus.
I don't feel if I have hidden hearing loss because I can hear voices and speech fine in loud places. I don't know if growing cochlear ear hair will regenerate connections to the nerves and repair the nerves. I don't know if I get a shot, will I get ultrasonic hearing and will hear dog whistles? Those are the unknown questions I am not going to ask because I don't even think the Doctor will know.
My post was aimed more towards hidden hearing loss, which is pretty hard to measure. But even measuring above 8 kHz is more tricky than measuring up to 8 kHz since it's so rarely done. And also there is a big chance that many especially older people have profound hearing loss at high frequencies where they could be pretty much deaf at that range. You have to remember that most people with hearing loss and tinnitus as well are above 45 years of age. It's simpler to do it this way and in a trial you don't want to complicate things more then they already are.
I actually called Decibel Therapeutics and left a message with them. I was called back by one of their people and he was very nice and answered all of my questions as well as he could, which was ziltch. I asked him if they were confident about their technology and he said they try and maintain a healthy level of scepticism. I asked them why they recieved series C investment if what they have doesnt work and he gave a (i know something) kinda giggle but then said he could not disclose what they showed their investors or whether or not it worked. I also asked him if he knew anything about the phase 1 success of their competitor Frequency Therapeutics, specifically whether or not the subject regained their hearing and he said he couldnt comment on that. He said just check the website every month or so. So that's that.
Why is it called fx-322? I have several Masons in my family and some of the Masonic regalia features a skull and cross bones with the number 322 under it. I wonder if Masons run Frequency Therapeutics and they named it that to glorify their fraternity.
Terrel
Member
- Jul 10, 2018
- 16
- Tinnitus Since
- 10/16
- Cause of Tinnitus
- Maybe not too loud music? Maybe something crawling in my ear
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