Frequency Therapeutics — Hearing Loss Regeneration

"This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery."

"Inclusion Criteria:

1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery."

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Would you be kind enough to point to me where it says it's been injected before implantation?

 

This is wrong. I have mild hearing loss in one ear and was accepted in the trial and went for physical. I left the trial after some concerns with getting the half dose.

 

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372587

"This injection will be performed by a specialist and qualified cochlear implant surgeon. The participants will differ in obtaining Placebo (12-24 hours prior to implantation) or FX-322 (18mg) and the time window for the injection
(either 12-24 hours prior to the surgery, 3-5 hours prior to surgery or 0.5-2 hours prior to the surgery)."

 

So you got the half dose or no, you didn’t? If you did get the half dose, did you see improvement?

 

Thanks for the clarification.

 

I did not get any. I was told if I got the placebo and there was a significant hearing increase in others I could be given a real dose at a later date. So I decided to let them find out what works and doesn't.

 

If we only knew what is considered by them "significant"... 10 dB or 40 dB...

 

December was the end of the 2nd trial, correct? So we should hear something this month on results?

 

REGAIN is another shit gene therapy, gene therapies have had historically mediocre results and they don't clone the progenitor cells first before creating new hair cells.

 

That is loudness hyperacusis, not pain hyperacusis.

 

It has a name: Noxacusis. But it´s just too fancy to use imo.
Point being, WNGs does nothing for the pain, probably just worsen it imo.

 

It's not a gene therapy.

Until we have one that's working and approved, ALL therapies have had historically mediocre results. Even though your tinnitus was caused by acoustic trauma, there may be a genetic component for all you know. I'd be cheering for gene therapy technology as much as for Frequency Therapeutics.

 

Yes, it is LY#####drug, a gamma secretase inhibitor. The same technology as FX-322, except FX-322 has other stuff that divides supporting cells. The REGAIN drug may also do this. Anyone else know?

 

They said January I believe.

 

Could someone e-mail Richard Mitrano and ask when they are publishing the results?

His e-mail is richard.mitrano@frequencytx.com

 

Something tells me it’s a good thing nobody in the trial has posted on this.

 

Really? I wonder how they manage to keep patients quiet. I could not avoid telling that I was injected with a new drug that healed my ears.

 

Of course you would be happy if it works and try to tell people but to be honest there are enough common methods in the business world to keep people quiet and it's even easier if you are a patient and really really need that drug.

For example:

If you say anything, they exclude you from further injections that could help you and if this is not enough they might include a high penalty lets say 100,000 and after that everything goes to the court and you have to pay even more money. Noone would risk that.

So silence doesn't mean anything here.

 

I am really happy for every company or research that is around hearing loss and tinnitus. God bless such researchers that focus on such a complex topic, I bet there are easier methods to make money - maybe a new fitness pill?

Also failing ideas are a step in the right direction for all of us... nearly everything we see around us is a result of trial and error.

 

But you can enter this forum anonymously and I guess nobody will discover you.

Of course those who are "healed" may want to continue with their lives without looking back.

 

I don't think the information about the quality/impact of the drug helps anyone that is outside the trial... What would you do with that information? Buy shares?

Penalties, court, etc. just slow down things so I am pretty happy noone says anything right now that could slow down the process to get the drug on the market. I mean you register with your email here on the board, right? I bet when you do something like that, they can ask - maybe even force - Tinnitus Talk to give out the login data and IP. Anyway that's getting off topic... I am not into law... this is very specific.

We don't know anything about the condition of the patients, so we should not speculate about their behaviour. Since my hearing loss I started to think of many complete deaf people or people who have other problems with their ears/hearing, so I really think such a situation is changing your personality and somehow I feel connected to them even if I don't know them and I don't think that will change anymore even after a cure.

 

If you truly wish to remain anonymous on the internet there are definitely ways to do this. You can buy an old laptop at a pawn shop with cash, load Linux, use TOR and a VPN, go find an unsecured WIFI access point somewhere in your neighborhood and wallah. You can also download lists of default WIFI router passwords all over the internet. Many times people just take theirs out of the box and don't reconfigure them and keep the standard password.

But if you were in the FX-322 trial I don't see why you'd want to do this, to possibly mess up the trial and slow it down.

 

It is a small trial and probably the people that are in it are not active in the forum or the tinnitus community. So hopefully they did get better and had improvements and told their families, doctors and friends. Also not everyone is posting everyday on Facebook or Twitter so I am keeping my hopes up.

 

Anyone in the trial will no doubt have to sign a non-disclosure agreement. Also many of those in the trial wont be in the trial just because they have tinnitus. It's pretty much a requirement that participants, if they do have tinnitus, have to at least pretend that the tinnitus doesn't bother them. I believe this is because they don't want any kind of psychological/emotional bias to effect the data.

 

Where are you getting this from? Is this directly from Frequency Therapeutics? I would have thought it would be the opposite. People with tinnitus and hyperacusis have much more to gain and need this much more than people who just have hearing loss.

I'm gonna try to get into the next stage of Frequency Therapeutics's trials. Do you think I should not mention my tinnitus or hyperacusis?

 

I think my tinnitus skews my hearing test results. On many of the beeps I just tell them I can't hear it over the beeps in my head. My last hearing test was on a bad tinnitus day and I scored pretty low in all frequencies. Since my losses are across the entire spectrum, I get a single beep that encompasses all frequencies.

They want people with hearing loss where the tinnitus doesn't bother them. I'm not sure exactly why but it could be as John Paul mentioned.

 

That may be true but the drug’s primary goal is to cure hearing loss. I think that is their focus with the trials, but obviously any improvement of tinnitus or hyperacusis would be a huge bonus.

You should definitely mention that you have both. They will want to know if the drug impacts either.

 

What about people that you socialise with. Family, friends, colleges.
How can you keep something like that a secret?

 

The same way you don’t tell them about every medical procedure you’re enduring. Obviously close family or friends would notice if your hearing suddenly improved, but you’d likely ask them to not tell others.

 

It's bullshit. They said they would let us know in December. It's now December. Some of us are hanging on a thread... each day is a day closer to giving up... I have emailed Frequency Therapeutics hundreds of times with no response. I also emailed FDA, no respomse. Nothing nothing. They just don't care