Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

      Location:
      Gothenburg, Sweden
      Tinnitus Since:
      05/2006
      Cause of Tinnitus:
      Noise - I think
      It's possible that regrown cells don't attach to a nerve and if they do regrown cells might perform worse than cells you're born with. Yes birds and zebra fish regrow hair cells but for them it's a normal mechanism. In mammals when hair cells die off there is scarring forming in those areas which could make regenerated cells less functional.
       
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    2. 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
      Thanks for the optimism... that really helps... cheers Silvio.
       
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    3. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      We know that for at least two out of a small number of participants in the last FX-322 trial, at least some regrown hair cells were bound to the neural pathway. That's something.

      He answered Street Novelist's question. That's all. There's nothing in his answer that should kill anyone's optimism.
       
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    4. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

      Location:
      Gothenburg, Sweden
      Tinnitus Since:
      05/2006
      Cause of Tinnitus:
      Noise - I think
      Well, maybe. More than one person had some improvement in hearing. But we don't know if that is due to new cells, new cells connecting to existing nerve, new cells AND a new nerve growth or just a restoration of the ribbon synapse between existing cells and existing nerves. And we won't know until those people are dead and they also testament their bodies to science so that we get to carve into their inner ears.

      But nonetheless, a big leap forward!
       
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    5. dmorg

      dmorg Member Benefactor

      Location:
      Philadelphia, United States
      Tinnitus Since:
      2011
      Cause of Tinnitus:
      don't know, hearing loss related?
      Just curious. Where did you see that 2 people had positive results. I must have missed that somewhere along the line.
       
      • Good Question Good Question x 1
    6. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

      Location:
      Gothenburg, Sweden
      Tinnitus Since:
      05/2006
      Cause of Tinnitus:
      Noise - I think
      You can read it in a press release note on Frequancy Therapeutics home page.

      http://www.frequencytx.com/news-events/news-events-press-release-04-09-2019.php

      "In the Phase 1/2 study, FX-322 was safe and well tolerated following a single intratympanic injection with no serious adverse events. In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients."
       
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    7. dmorg

      dmorg Member Benefactor

      Location:
      Philadelphia, United States
      Tinnitus Since:
      2011
      Cause of Tinnitus:
      don't know, hearing loss related?
      Thanks for the reply. I am familiar with Frequency Therapeutics and the study. I guess what I was asking was that they announced somewhere and I missed the fact that there was just 2 (or a few patients) with positive results. Hoping it is more like “most” or “all” patients saw some level of positive results.
       
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    8. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      I reckon many patients will need to have multiple treatments for it to be successful. Maybe the reason why those 2 patients were successful is that they only needed one dose.
       
    9. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

      Location:
      Gothenburg, Sweden
      Tinnitus Since:
      05/2006
      Cause of Tinnitus:
      Noise - I think
      Not JUST 2. At least 2. Multiple implies more than 1, which is AT LEAST 2. But there could be more.
       
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    10. 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
      I stand corrected. I was being emotional as opposed to being scientific. I agree with you. Ooops.
       
    11. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      That's at least 2 out of quite a small number of participants who got the FX-322.

      Does anyone else think that FX-322 are managing information flow for dramatic effect? They could have simply said nothing about efficacy or they could have given full information. It's not as if there were that many numbers they needed to process. Instead they gave us a teaser with the full movie held back for that wow factor in front of an audience of their peers.
       
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    12. tarmaced
      Wtf

      tarmaced Member

      Tinnitus Since:
      2004 (mild) 2018 (not so mild)
      Cause of Tinnitus:
      Ear infections, compounded by noise exposure
      I was thinking on this last night. I believe it is possibly for business purposes - e.g. the less competitors know the less well informed they are to invest in similar or alternative medicinal strategies for the same (e.g. hearing loss related), or other purposes. Having potential competitors less informed is always an effective business strategy, particularly at the investment level that the kind business invested in; an extended development-phase product. So I imagine this is likely just part of managed information release.

      EDIT: Hard to read. Less hard to read now. Still hard. Eh.
       
      Last edited: Jun 1, 2019
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    13. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      There's going to be an event on September 18th, 2019 and that's where they will talk about the trials and hopefully mention tinnitus and hyperacusis being resolved.
       
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    14. Don Tinny

      Don Tinny Member

      Location:
      Argentina
      Tinnitus Since:
      2017 (worsening)
      Cause of Tinnitus:
      Loud concert with ear plugs
      Do you think so? Tinnitus is usually taboo. :S
       
    15. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      I have no clue what they are going to do. I just hope they do mention it.
       
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    16. just1morething
      Benevolent

      just1morething Member Benefactor

      Location:
      U.S.
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      barotrauma, noise exposure, TMJ, neck?
      Why will you be dead?
       
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    17. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
      Tinnitus Since:
      4-15-2017
      Cause of Tinnitus:
      Acoustic trauma
      You're right, I'm not that old! I think I was trying to use hyperbole to make a point.
       
    18. just1morething
      Benevolent

      just1morething Member Benefactor

      Location:
      U.S.
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      barotrauma, noise exposure, TMJ, neck?
      I had to google hyperbole (my vocabulary isn't that great) I hope you are doing reasonably well and if not some technology in the near future helps. I seemed to be helped short term with steroids but mine might be partially neck/TMJ related. Loud hissing atm. I have HF hearing loss. Will receive Audicus Clara HA soon. I lost my right HA and traded up. I can hear okay, it's mainly the tinnitus bothering me.
       
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    19. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      What frequency do you have 20 dB and 40 dB losses at?
       
    20. just1morething
      Benevolent

      just1morething Member Benefactor

      Location:
      U.S.
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      barotrauma, noise exposure, TMJ, neck?
      My latest audiogram. I almost fell asleep during it. I don't know how to interpret them that well. They wanted to sell me Starkey hearing aids which were very high priced, so I went with Audicus Clara instead. Tinnitus didn't seem to bother me that day. ENT sucked quite a bit of wax out of my ears.


      img110.jpg
       
      Last edited: Jun 5, 2019
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    21. Fabrikat

      Fabrikat Member

      Tinnitus Since:
      1973
      Cause of Tinnitus:
      Otosclerosis then volume then viral infection
      Your audiogram, whilst not great, is not that bad either. Do you really need hearing aids or do you like wearing them to enhance perception of upper frequencies? Or do they actually help with tinnitus masking?

      I have read about Audicus aids. Have you tested them yet? How do you find them?
       
    22. just1morething
      Benevolent

      just1morething Member Benefactor

      Location:
      U.S.
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      barotrauma, noise exposure, TMJ, neck?
      I'm only really using them because I sometimes have severe static noise when I wake up, like right now. It could be related to my neck/tmj, I'm not sure. Just looking for relief of some kind for my typical static.

      I do have a masking sound in programs 2 and 3. I have the remote control that I really like. I'm receiving their new Clara model tomorrow according to my tracking #. I had lost one of their cheaper Dia models, but now found it. I wanted that as a backup, but I think they sent it off already with others to their repair/warehouse center in Minneapolis. So it's doubtful they will find mine if it's mixed with others. They gave me a $100 credit for the one I sent in with my remote to be reprogrammed. Also another $100 for the Dia that they discontinued.

      I am also getting their rechargeable battery option with a docking station for overnight charging.

      I have seen eBay has quite a few used HA for sale also at cheap prices. I found the Audicus brand on this forum here:

      https://www.tinnitustalk.com/threads/regular-hearing-aids-are-curing-my-tinnitus.25523/#post-324053
       
      Last edited: Jun 6, 2019
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    23. just1morething
      Benevolent

      just1morething Member Benefactor

      Location:
      U.S.
      Tinnitus Since:
      2008
      Cause of Tinnitus:
      barotrauma, noise exposure, TMJ, neck?
      Audicus told me today that they were able to reverse ship my other hearing aid so now I will have my old pair as backups. They just have to reprogram it again as they wiped out the programming to my audiogram.
       
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    24. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      When is the next trial, 2035? I don’t get it, a company comes out and for the first time claims to actually improve hearing. Why aren’t they moving faster or at least other scientists or companies jumping on the bandwagon and helping out.
       
      • Agree Agree x 5
    25. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      They have a golden period between the first annoucement and the end of phase 3 when they can make claims to increase their stock prices, regardless if the drug works or not.

      Someone very close to me was diagnosed with ALS and when I first started looking it up there was a drug that claimed it not only stopped ALS, it reversed it. Apparently not happening... Not to be a downer but take it all with a grain of salt.
       
    26. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      What company was this? First off, if it was deliberate misreporting, that's fraud. Sure fraud can and does happen but it's not excused under some grace period rule.

      Second, Frequency isn't a publically traded company so they would be defrauding private wealthy investors (who have lawyers with way more teeth than the ineffectual SEC) and this would be a Theranos-level of medical misrepresentation and scamming, if so.
       
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    27. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      They all do it. It is called puffing in legal terms and is not illegal. They are looking for a cure, and are chasing down what they deduce will be a chance at some type of treatment, but they cannot be sure until it is tested. So they make extremely positive and reaching announcements. Sales and marketing is alive in the drug development world.

      I am not a stocks and bonds guy, but it says they got $32 million dollars in their startup round...

      https://endpts.com/frequency-therap...d-to-help-fine-tune-its-hearing-loss-drug-rd/

      As far as the ALS trial I was talking about, it is the company Brainstorm.

      https://alsnewstoday.com/2018/07/26...-completion-phase-3-nurown-trial-new-patents/
       
    28. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      The money Frequency Therapeutics got in their startup round was from private investors. They have never been publicly traded. Generally, private investors want a little more than puffed up optimism to invest millions in a biotech.

      Read a bit about Brainstorm. It said the treatment reduced inflammatory markers in the CSF. Was that not true (i.e. they published fraudulent results)? Or did it turn out reducing CSF inflammation was immaterial in treating ALS?
       
    29. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      Public or private they are still raising many many millions from the press releases stating that they can cure hearing loss. I am not convinced that they have the magical miracle cure they are saying they have. I really hope they do... As a professional musician I hope they do. I really do. But after the ALS press releases and then watching my family member wither away to nothing I am cautious with my hopes.

      In the initial press releases I read online with Brainstorm they, or some article that was put out there on their behalf, said their process would not only stop ALS, but it would reverse it. That was a few years ago. Everyone was drinking the KoolAid. After the 1st and 2nd trials, they went to the 3rd trial. I called one of the universities and spoke to a medical professional that was working on the 3rd trial. She did not give me the impression the treatment was doing anything miraculous.

      There was another drug from Japan. It was supposed to slow down the progress by a long time. It costs $25,000 USD per month. Now there is a knock off from Bayer for $5,000 USD per month. People all over the world were and probably still are going there or having it shipped in. Then I read an article that it had a very low success rate, and it only affected a small cohort of Asians with a specific type of genetic ALS.

      Anyhow after thinking we would be able to use the Asian meds until the Brainstorm cure came through, and over a few years watching it become a false dream, I studied the pharmaceutical industry a bit and it is par for the course. They have this golden period where they can raise fantastic amounts of money during the honeymoon stage. As the final stages of testing are completed the reality is it does nothing or maybe a marginal percentage.

      I also have psoriasis and have watched this process go on with psoriasis drugs as well.

      The last thing I will add to this discussion is about the genetic cure Brainstorm was touting. I discovered there is only one disease that has a genetic cure. It is a type of genetic eye disease that causes blindness. The cost is $850,000 USD per eye for the treatment.
       
    30. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I can't comment much on Brainstorm but I followed a different biotech Sarepta Therapeutics, for years, and their gene altering drug Eteplirsen quite closely as the trials were unfolding. If you read their statements, they said the drug increases dystropin and therefore improves Ducchene Muscular Dystrophy to the point where it is more like Becker's (huge improvement for these kids). All claims were "this drug improves dystropin production" and "walk test results improved on this drug." And it does work. The drug is a breakthrough. By the way, Eteplirsen works at the genetic level as well.

      Perhaps with Brainstorm, the CSF markers they evaluated (what I saw them reporting in the search I did on them) were not a good marker for the effectiveness of treating ALS or it is too heterogeneous of a disease. It wasn't false to report the CSF changes but perhaps not all that relevant (unfortunately for your family member :( ).

      We are way behind on hearing loss research but we *do* know functional hair cells are directly related to hearing ability. I see this as a huge difference between Frequency Therapeutics and Brainstorm. Frequency Therapeutics has shown in vitro it can regrow human cochlear hair cells. If they can show changes in audiogram after treatment, their claims are credible and they have accomplished hearing regeneration. There isn't as much wiggle room in their findings here. Either people could hear better or they couldn't.
       
      • Agree Agree x 2

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