Frequency Therapeutics — Hearing Loss Regeneration

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

    1. blamingeverything

      blamingeverything Member Benefactor

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      high frequency hearing loss
      I thought the Dr. Shore device was only effective while using it and tinnitus returns after cessation.
       
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    2. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Anecdotes are evidence. So, now you're just moving the goalpost and mocking? Nice way to minimize your argument on a public forum. Also, Frequency Therapeutics clarified that they rejected the data from the Phase 2B because it couldn't be distinguished from placebo. So, there's no reason for them to post TFI scores, since they were secondary outcomes.

      By the way, do you own some FREQ shorts that are at-risk now that the stock is rebounding? Because your arguments are severely one-sided and rather tone-deaf with other members as well.

      This will be my last engagement with you, I don't think this dialogue is helpful for the readers here that actually want to learn about the research going on with this firm.
       
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    3. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Aren't the positive effects from Trobalt anecdotal too? I'd love to see a source claiming otherwise.
       
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    4. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Separate to the prior arguments on here, no one knows if FX-322 / FX-345 will treat tinnitus. I admire the work Frequency Therapeutics are doing and I am excited by FX-345.

      As I have repeated many times, Bob Langer does not fail. To be the most cited engineer in history is some accomplishment.

      I believe that Frequency Therapeutics will get there and produce an efficacious treatment for hearing loss but a lot is unknown about the durability and function of regenerated hair cells, plus their ability to form connections to the synapses. Will these 'new hair cells' be as good as the original. It is all unknown and is very interesting.

      I am however worried about funding. They need good news fast.

      I recently spoke with a Professor who has connections with Bob Langer and he was not all that enthused with PCA, but is focusing on gene therapy.

      Progenitor cell activation would be amazing if it works.

      I will keep a head in here and not post further as people need hope, as I do very much every day, to keep me going. I do feel as a 'tinnitus' treatment it should not be the hot topic it is.

      That is my opinion and hey, I'm only one person, but facts are facts and at this present time there is no evidence that it will help tinnitus. No evidence apart from company reported 'anecdotes'.

      I hope it will treat tinnitus. It would be amazing.
       
    5. koffee_monster
      Sleepy

      koffee_monster Member

      Location:
      West Europe
      Tinnitus Since:
      02/2022
      Cause of Tinnitus:
      Noise Exposure or Ototoxicity
      @Nobody19, @Diesel, @Padraigh Griffin (in no particular order),

      It was not my intention to start a personal discussion here. I was inquiring if perhaps @Padraigh Griffin had certain information giving him a negative outlook on the FX-XYZ trials that I was unaware of.

      I also pointed out some glaring issues with Potassium regulators and Trobalt in particular as a continuous treatment.

      @Padraigh Griffin replied with the valid argument that my sources were pointing to Trobalt and not really Potassium regulators in general and that the FX-XYZ lineup has indeed been somewhat less performant than some of us would have expected at this point (I don't have an opinion on this, I try to look at research in the most objective way I can).

      Some issues of Trobalt will most likely be part of the XEN side-effects too, but hopefully, it will indeed be to a lesser degree.

      Both approaches still seem very valid to me and I do not at all have the feeling that one approach should cancel out the other. They can perfectly coexist and may even amplify each other's effect on tinnitus.

      Tinnitus research is fragile as-is, let's not create in-fighting in the people that actively try to follow the research space.

      Let us not break down other people's hopes and ideas about upcoming treatments as for many (including me) the built-up expectations for treatments is what makes having tinnitus a lot more bearable.

      Even if those expectations aren't always correct or justified, they help people cope, push through and research the matter further. There's no point in attacking those expectations only for the sake of attacking them. If a person would be in danger because of misinformation that's another story.

      I hope this conversation can continue in a polite fashion and that we can focus on the objective research part of this thread.
       
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    6. SmallRonnie
      Ape-like

      SmallRonnie Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Hyperacusis: Factory Noise / Tinnitus: PC Noise
      This does sound really hopeful but again who knows what else may go wrong with it.

      It will still take at least a couple more years before it's available too, if it even is at all.

      I'm going to get stem cells in the mean time since it's so similar to this.

      I really hope FX-322 it does work, it would bring so many people such great relief. Even if it just made things a little better.

      FX-345 should be even better again.

      Do you know the route of administration? Is it an injection through the ear drum or what?
       
    7. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      FREQ has gone above & beyond the vast majority of biotech companies in doing their due diligence with all of their preclinical and clinical research and sharing it all openly with the world but you consider it overhyping?

      Here is all the "anecdotal shite" FREQ has done so far:

      - They treated mouse cochlea ex vivo with aminoglycoside for 16 hours to kill off the cochlear hair cells, they then treated with FX-322 and returned cochlear hair cells back to healthy levels.

      - They conducted a noise deafened study in 47 mice against a placebo group of 37 mice. They measured hearing via auditory brainstem response and saw 70% of the treated group recover after treatment with FX-322 while only 30% of the placebo group recovered. The placebo recovery was attributed to typical recovery of acute hearing loss and not attributed to hair cell death.

      - They used in vitro rhesus macaque progenitor cells that showed FX-322 caused the progenitor cells to replicate and mature into hair cells just like it did in human cells.

      - They've done perilymph sampling in guinea pigs of FX-322 distribution through the cochlea in order to assist their human modeling calculations.

      - They conducted a cochlear implant study showing the FX-322 actually diffused through the round window membrane, proving that FX-322 reaches therapeutically active levels in the base of the cochlea.

      - A Phase 1/2 placebo controlled safety study in humans with 23 participants which also measured hearing function and followed up 12 months later to asses durability of hearing improvements.

      - A Phase 1, open label study of 33 participants testing different administration conditions across a wide range of severities and cohorts with an ongoing durability study follow up roughly a year later.

      - A Phase 1, placebo controlled age related hearing loss study of 30 participants.

      - A Phase 1, placebo controlled severe hearing loss study of 31 participants.

      - A Phase 2a, placebo controlled study in approximately 95 participants.

      - They are currently enrolling a Phase 2b, double blind, placebo controlled trial with 124 participants.

      And you think they're over here hyping when they are doing the exact opposite by proving that they have done their due diligence.

      Source - https://investors.frequencytx.com/node/8296/html
       
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    8. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Yes, it's administered via intratympanic injection. It then gels up at body temp in the middle ear space so that it can have time to diffuse through the round window membrane.
       
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    9. Athens

      Athens Member

      Tinnitus Since:
      09/27/2020
      Cause of Tinnitus:
      Unknown
      If tinnitus and/or hyperacusis is/are caused by damage to the auditory nerve, I assume that these drugs will likely not be helpful.
       
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    10. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Nothing here for tinnitus YET.

      I have repeatedly said that there is nothing but ANECDOTAL clutching at straws 3 participants, no TFI, no clinical significance, no placebo controlled evidence that FX-322 will help tinnitus.

      I apologise if this is of offence to anyone but they are the FACTS as regards to tinnitus. Keep your eyes open. There were many depressed people on here after very poor Phase 2 results.

      I will not post here on this thread anymore unless someone replies to my posts that are here already. I have stated counter arguments and if they are not factually correct then I hold my hands up, but I think you will find that they are.

      I have also repeatedly said I believe in Frequency Therapeutics and have high hopes that FX-345 might help hearing loss and HOPEFULLY tinnitus.

      The fact remains that none of us here know whether FX-322 or FX-345 help tinnitus.

      I, like everyone here, hope they do.
       
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    11. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      An article that came out today from MIT about Frequency Therapeutics.

      Reversing hearing loss with regenerative therapy

      Some notable excerpts and quotes from the founders of the company:

      "Some of these people [in the trials] couldn't hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying," Langer says. "It's so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me."

      For now, Karp is already thrilled with Frequency's progress, which hit home the last time he was in Frequency's office and met a speaker who shared her experience with hearing loss.

      "You always hope your work will have an impact, but it can take a long time for that to happen," Karp says. "It's been an incredible experience working with the team to bring this forward. There are already people in the trials whose hearing has been dramatically improved and their lives have been changed. That impacts interactions with family and friends. It's wonderful to be a part of."​
       
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    12. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      A lot of it seems to be driven by the anxieties of those with a vested stock position in the company.
       
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    13. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Good stuff. Interesting to see that participants with an injection in only 1 ear are seeing that type of improvement in daily life. Often in this forum, we overlook the QoL factors and get too fixated on the clinical measurements. However, the FDA will take into account QoL data as part of the evaluation process. It will be interesting to see how their “RADIAL” analysis works out in the Phase 2B.
       
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    14. dbeats

      dbeats Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Loud noise
      Do stem cells actually destroy progenitor cells, or did you make this up? Any sources?
       
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    15. blamingeverything

      blamingeverything Member Benefactor

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      high frequency hearing loss
    16. dbeats

      dbeats Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Loud noise
    17. blamingeverything

      blamingeverything Member Benefactor

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      high frequency hearing loss
      It's in the latter half I believe.
       
    18. dbeats

      dbeats Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Loud noise
      Around 52:00 is what I'm assuming he was referring to. Seems to me like they are talking about gene therapy and not stem cell therapy?
       
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    19. Aaron91
      Gloomy

      Aaron91 Member Podcast Patron Benefactor Ambassador Advocate

      Tinnitus Since:
      2007
      Cause of Tinnitus:
      Loud music/headphones/concerts - Hyperacusis from motorbike
      I believe they are confusing the transdifferentiation approach trialed by some other biotechs (which depletes progenitor cells) with the asymmetrical approach used by FREQ (via Wnt and notch pathways), which doesn't deplete progenitor cells.
       
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    20. Gorbeh3

      Gorbeh3 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing Loss
      Does anyone have insight on the state of Frequency Therapeutics right now? I have been seeing a lot of new articles out there but no new information, possibly suggests they are on a media campaign to try to revive a company in decay. I also heard rumors they had to lay off a bunch of staff...

      Doesn’t look great tbh...

      That being said, I’m really optimistic for FX-345.
       
    21. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Their stock has been hammered over the past year. And yeah they had to lay off staff.
       
    22. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      Ya, I’ve noticed the same article circulating about a patient that can hear better in a restaurant. I agree it seems like they are doing a rescue media campaign right now. We will just have to wait to see if the current trials will show any improvement.
       
    23. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Everything is still on track. They laid off 30% of their workforce in order to preserve capital. This move ensures that they will see data on FX-322, FX-345 and FREQ-162 before they run out of money. If these trials are successful, the stock should recover nicely and then they should have no issue doing a share offering. They may even be able to bring in a partner on FREQ-162 that could result in milestone payments much like they did with Astellas.
       
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    24. Geatly

      Geatly Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Noise induced, by jackhammering into concrete on constructio
      Amount of money going for war and armies, and we are unable to fund from public money such great opportunity to regain hearing for millions of people, shame.
       
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    25. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      upload_2022-4-18_20-38-13.png

      Yes it is confirmed that workforce reduction of 30% took place and also the CFO stood down on 31st March.
       
    26. JPGL
      Frustrated

      JPGL Member Benefactor

      Location:
      Spain
      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      Hearing loss? Noise? Stress? Unknown
      FREQ rises 42% in the stock market. Is there any good news about FX-322 that justifies this rise?
       
    27. blamingeverything

      blamingeverything Member Benefactor

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      high frequency hearing loss
      Wow. That’s not nothing. CFO bowing out is not great either.
       
    28. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      He got fired.
       
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    29. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      CFO was part of the layoffs based on the fact that they are paying him an entire year salary, $189k bonus and $20k in relocation expenses after he is gone. He was given the option to "step down". They then promoted the Vice Financial Officer up to CFO who has been with the company longer so they essentially trimmed the fat.

      https://investors.frequencytx.com/node/8316/html
       
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    30. LAnative
      Fine

      LAnative Member Benefactor

      Location:
      California
      Tinnitus Since:
      06/2018
      Cause of Tinnitus:
      Gunshot
      I have two theories for today's stock spike:

      1. Things are looking good in the trial. Perhaps some insiders are leaking info to their friends/relatives. Some might say this is not likely, but do you guys remember the sketchy sell offs in the days before the bad Phase 2 came out? I personally believe there was something sketchy going on back then, because there were big sell offs RIGHT before the news came out. It could be happening again, but at least this time it could mean the drug is working.

      2. We all saw the random news articles about Frequency Therapeutics' drug making the rounds in the last few weeks. If I'm not mistaken, the first one came from MIT, which a lot of the top brass in this company graduated from. The same article was repackaged from maybe half a dozen different science sites. My own friends were sending me the articles, even though this was quite old news. A classic pump. There were large Easter family gatherings just yesterday where word of mouth could have spread, and now everyone's uncles and aunties buy into the hearing restoration stock.

      Just some random guy's two cents.
       
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