Frequency Therapeutics — Hearing Loss Regeneration

Discussion in 'Research News' started by RB2014, Dec 8, 2016.

    1. Bndsmheowqhe

      Bndsmheowqhe Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Loud noise exposure
      Based on the positive demeanor of the CEO and people associated with this my gut is telling me that they've really got something here. It's the complete opposite of what I'm seeing from a certain other tinnitus treatment company.
       
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    2. GSC
      Wishful

      GSC Member Hall of Fame

      Tinnitus Since:
      02/2019
      Cause of Tinnitus:
      Acoustic trauma.
      A decade what... Not at all... what...
       
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    3. fade2black244
      Inspired

      fade2black244 Member Benefactor

      Location:
      TX
      Tinnitus Since:
      03/24/2017
      Cause of Tinnitus:
      Noise Induced
      I have a feeling that either this will come out in the next few years or it will not come out at all. But all indicators point to that it works.
       
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    4. john paul
      English

      john paul Member

      Tinnitus Since:
      11/11/17
      Cause of Tinnitus:
      acoustic trauma
      I'm glad I came here today. :) This is such great news. Id love to think that in 12-18 months we have at least a treatment or some kind of assurance we will all be saved one day. This is a great day.
       
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    5. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      PS: next time I visit my ENT or family doctor, I’m going to print out the most promising tinnitus treatments, including the latest article on Frequency Therapeutics mentioning the hearing improvement and the STAT News article on Dr. Susan Shore.

      I think it can do no harm if we start spreading the news to get the local medical practitioners’ attention. My own doctor has tinnitus himself.

      If they have the right mindset, they would want to keep track of something huge like this.

      Anyone else up for this?
       
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    6. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      I appreciate your summary here. I wonder if these sorts time scales would necessarily apply to a drug candidate such as FX-322, since it is not a systemic, regular or chronic use medication.

      FX-322 seems to be a very short term drug administered once, maybe twice, or even say three times and then eliminated by the body. It's not ingested or administered on an extended term basis, so it's not as if the researchers have to hang around and wait to see if causes any malignancies or disabilities after long term use like many other drugs. Antidepressants are a good example.

      I'm speculating of course. I have no idea how these things go. Like everyone else, I'm just willing this thing along in the hope that this drug's path to the market may be a little shorter than most.
       
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    7. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      Let’s just go on what Frequency Therapeutics predicts for now. They seem to know what they’re doing with their FX-322, that gives me confidence that they know what they’re doing in terms of planning as well... if it’s longer, it’s longer.

      We’ll see...
       
    8. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      Awesome idea... everybody should do this... everybody on this forum.

      Pero, if you can make a PDF file of treatments and share it, great, but if you can't, we can all easily write down the latest technological and medical breakthroughs. We need to school the medical professionals so they can do their jobs properly.

      Great idea Pero1234.
       
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    9. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      I’ll put something together.
       
    10. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      If the linings in our stomach regenerate every 4 days, I wonder if this is something that can be used not only more than once, but maybe even on a long term basis. Maybe a shot a month for a year... to get your hearing back. I'm speculating too. Maybe a shot every few years to keep people at perfect hearing so that tinnitus goes away.
       
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    11. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      Thanks! My “analysis” was just a statistical estimation based on a median of wide variety of drugs approved and should be read only in that context. Key message is that a breakthrough designation speeds up the process by several years -> median to approval from 8 years to 4.8 years.

      I have also wondered why it is taking so long when we are talking about a single (or 2-3) intratympanic injection instead of building up the drug exposure over time with daily pills. Like you write for example antidepressants take several months to reach a steady state and full effect. My guess is that the somewhat unconventional way of drug administration and high risks related are the reason it has taken a long time.

      The first trial (May 2017-January 2018) was done on 9 profound deaf persons who were candidates for cochlear implant so that there would be no risk of anyone losing their hearing in the trials. Since they are not the target group for FX-322, Frequency Therapeutics needed a second safety trial (July 2018 – April 2019) and that was done on 23 persons with stable hearing loss less than 70 dB. Due to having to complete two consecutive safety trials it has taken two years with only 32 participants which feels like a long time.

      The question is does FX-322 take full effect in a couple of days, weeks or months? If it shows full effect rapidly then there is a possibility that things start moving on much faster from now on as safety has been confirmed.
       
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    12. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      Interestingly, I have read researchers state that although drugs that regenerate hearing are readily available, the problem is getting them into the ear in sufficient quantity and long enough to take effect. No doubt this is the challenge for Frequency Therapeutics too!

      https://www.tinnitustalk.com/thread...t-for-hearing-loss-with-nanotechnology.32275/
       
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    13. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      From my experience, it takes months.

      I'm guessing that although they saw improvements, they weren't as robust as they wanted and that they now need to test multiple doses, which is what the next phase will test. Getting the dosage and the dosing schedule right may take a very long time, unfortunately, fast track or no fast track.
       
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    14. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      I think that what you have said here is exactly correct. It could even be a shot a week for several weeks or months.
       
    15. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      So the breakthrough designation shortens the drug approval process in average about 3 years. I am wondering would it help to gain a breakthrough designation from FDA if there was a petition signed by a substantial number of people with hearing loss and tinnitus?

      I am just thinking if there is anything we could do to help Frequency Therapeutics move faster. Sorry if this has been discussed here before.
       
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    16. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      I agreed with what you are saying, but they noted improved word scores... I'm guessing that has to be good for at least 10 to 20 dB improvement across the higher frequencies (2 kHz to 8 kHz and beyond...). Hopefully they concentrate on dosage and not schedule, because that could take a long time. It might also be different for different people. I'd be happy with a 15 dB on the first shot, then 10, then 5, then 2 etc etc. If it can take someone at close to CI level and take them back to hearing aides, that would be good enough for me.
       
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    17. john paul
      English

      john paul Member

      Tinnitus Since:
      11/11/17
      Cause of Tinnitus:
      acoustic trauma
      You just don't understand clinical trials I don't think. They don't rush anything and they don't just go at it like amateurs. They review everything down to the tiniest detail so they can provide clear solid evidence. Stop being so negative about it, it takes time to go through the process and do it properly. They are not bothered about trying to sort it out as quickly as possible, they will sit around and talk about and plan the next move until the cows come home and move on from there. They are driving in the dark, trying to avoid the ditch at the side of the road and have a long and rocky journey ahead of them. Stepping on the gas peddle is just not how you do things if you want to be sure you get to your destination.
       
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    18. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      You think wrong.
      Absolutely nothing about my comment was negative.
      Right, that's why I said it may take a long time. It also unnecessarily takes more time because the FDA system is definitely broken.
      Did you even read my comment? I said it may take a long time to get the dosing right. Frequency Therapeutics wants to move as quickly as they can, even if that means moving slowly.
       
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    19. Aleksa Uzunovic

      Aleksa Uzunovic Member

      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Noise induced hearing loss
      Well, I think that if they don't realize that this is one of the most urgent medical needs in the world currently, and that it needs to be maximally sped up, than they are bunch of freaking retards. No need for petitions, there are hundreds of millions of people with hearing loss and if they don't realize that most of those people need a cure as soon as possible they should just straight up close FDA, it is a freaking useless organization and a drain in the budget.
       
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    20. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
      Cause of Tinnitus:
      unknown
      And even if everything runs fast, I can imagine that marketing and pricing, deals with insurances will take additional time.

      It‘s never fast. But I am happy to see where research is... and a clinical trial of regenerative medicine is an exciting phase.
       
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    21. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      I don't know much about this stuff either, and I've said all of this before, and Fabrikat said most of it again, but anyhow...

      This is not like most drugs. The effects are clear-cut. It either works or it doesn't and the degree to which it works is easily measurable. Contrast with an anti-tinnitus drug (for example) where you're relying on subjective assessments. Note how they were able to announce positive results within just a few months. Also, the ear is isolated from the rest of the human body. Chances of systemic interactions are low. I say it will be available within a few years or never.
       
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    22. Deathtotinni

      Deathtotinni Member

      Location:
      Parkville Maryland
      Tinnitus Since:
      9/10/17
      Cause of Tinnitus:
      Qtip and maybe a sound..who knows
      Too fast with the clinical trials. It’ll be out in the next couple years.
       
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    23. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      You are awesome, your optimism makes me stoked.

      Well done on the Stanley cup, you deserve it.
       
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    24. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      It's easy. The chemical diffuses through the round window of the cochlea and comes into contact with dormant stem cells. They wedge into notches on the outside of the cell called signalling pathways, this in turn starts a chain of events that prevents a compound called beta catenin from being destroyed. When enough beta catenin builds up inside the cell, it enters the nucleus. Once in the nucleus it triggers a process called proliferation which basically wakes it up and then through a process called paracrine, the stem cell morphs into a cell like the ones near it, which in this case are sensory hair cells.
       
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    25. Fightthearmy

      Fightthearmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      work-related
      That's very insulting towards the many high-ranking people in the FDA who have dedicated THEIR LIVES into the making of the FDA. Take David Kessler, for instance, former commissioner chief of the FDA. "It's the fastest and most efficient drug-review program in the world!" he said in 2017.

      Michael Carome, director of Public Citizen's Health Research Group: “The FDA is promoting speed over the rigor of evidence” (in judging products' safety and effectiveness.)

      Vinay Prasad, oncologist, assistant professor of medicine at the Oregon University: "The FDA reviews should be tougher, not easier."

      And they think you are a deceitful, inflammatory, misguided and unfair nuisance and you need stop spreading these lies.
       
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    26. Aleksa Uzunovic

      Aleksa Uzunovic Member

      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Noise induced hearing loss
      Dude, why don't you just go and straight up work for Frequency Therapeutics. You're living encyclopedia on the field :bookworm: :D
       
    27. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      Maybe you’re right, maybe not.

      Breakthrough designation has to be for life-threatening disease. It does not mean that the treatment itself is a breakthrough so the name is very misleading. https://en.wikipedia.org/wiki/Breakthrough_therapy

      It has been used for cancer, fibrosis, HIV etc. It has not been used for treatments similar to hearing loss drugs. Maybe the closest is diabetic retinopathy. Only 15-30 drug candidates have received it per year so it is by no means certain for Frequency Therapeutics. https://en.wikipedia.org/wiki/List_of_drugs_granted_breakthrough_therapy_designation

      I believe that FDA citizen petition with large number of signatures would support greatly gaining a breakthrough status and be much stronger message than just Frequency Therapeutics applying for it on its own.

      For example a public petition with 1 million signatures calling for the fastest possible track for Frequency Therapeutics. https://en.wikipedia.org/wiki/FDA_citizen_petition
       
    28. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      "I believe the clinical trial system is broken," said Janet Woodcock, who has worked at the agency for more than three decades, at an industry panel on Nov. 14. "I do not believe it serves the interests of patients."
      https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/

      Those people don't even know who I am anyway. LOLOLOL.
       
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    29. john paul
      English

      john paul Member

      Tinnitus Since:
      11/11/17
      Cause of Tinnitus:
      acoustic trauma
      It really did come across that way, I apologise as I was slightly irritable at the time and it was unjustified but really it was a fairly negative view point. They achieved exactly what they set out to do, it's safe and it works. Nothing to do with not getting good enough results and so they will test it with more doses. That's just not the case IMO.
       
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    30. SergioN

      SergioN Member

      Tinnitus Since:
      25/07/2005
      Cause of Tinnitus:
      Acoustic trauma + ototoxicity
      My pending concerns are:

      - How does the drug know which supporting cells need a hair cell and which do not? Because there will be damaged zones and healthy zones.

      - What about if there are not enough supporting cells? You get a hair cell but you lose a supporting cell?

      - Supporting cells are going to be multiplied in a controlled way?
      It seems magical... but they say it worked!

      I'm in a critical situation because i was trying to start tapering a benzo (Clonazepam 0.5mg after 2.5 months), I have removed like 2% from pill, and third day tinnitus has spiked a lot. So returning to initial dose and praying for ear regeneration.

      Thanks to all.
       
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