Pipeline Therapeutics

Discussion in 'Research News' started by FGG, Nov 14, 2019.

    1. CLB2020

      CLB2020 Member

      Tinnitus Since:
      07/2020
      Cause of Tinnitus:
      Infection & Stress/ Anxiety
    2. GBB

      GBB Member Hall of Fame

      Location:
      NYC
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      Virus / Microsuction / Acoustic Trauma
      I’ll definitely be following your experience closely if you decide to pursue.

      Also I’d be in South Korea already if it weren’t for COVID-19...
       
    3. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      @GBB, right now I am just figuring out how I want to tackle this.

      I have been offered 2 grams of NGP-555 for $1900 AUD or $650 AUD for 500 mg.

      On the patent it says (50 mg/kg, b.i.d.) which is 50 mg twice a day. My bodyweight is 100 kg so I would need 5 grams per dose which is WELL out of my price point. I would need 50 grams to achieve those doses and that would cost around $40,000 AUD. At the same time 50 mg/kg doesn't sound right as on the Alzheimer's studies I have read once patients got up to the 300 mg dosage they started experiencing adverse effects. So this leaves me unsure of what to do.

      I'm thinking of trying 50 mg per day for 10 days. So 500 mg divided up into 10 capsules with 100 mg of 0.5% Methylcellulose. All up it'll cost me around $750 AUD.
       
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    4. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      With the clinical trials underway, I think PIPE-505 and OTO-413 will conveniently come out before the need to obtain drugs containing the relevant pharmaceutical properties of these drugs from other countries. Currently I would also actually prefer to try the drugs that have been purpose produced to treat specific issues and actually gone through relevant clinical trials, rather than trying to take a drug that has shown to be effective but is not specific.

      It seems that the drug is quite expensive too though if it is bought from a foreign source.
       
    5. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      @GBB, so you'd be going to that Minbo Shim clinic in South Korea to get your hearing loss and tinnitus treated if it wasn't for COVID-19?
       
    6. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
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      If you decide to do it, please keep us posted about results.
       
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    7. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
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      Which product contains NGP-555 from the website you're buying?
       
      • Good Question Good Question x 1
    8. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
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      There is a reason most of these drugs in trial for hearing disorders are given intratympanically and that is because, in order to achieve therapeutic doses that cross the blood-cochlear barrier in high enough concentration, you have to use massive doses. Those massive doses have a lot of potential for harm with a lot of substances given systemically.
       
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    9. GBB

      GBB Member Hall of Fame

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      It would be one of the options I am seriously considering.
       
    10. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      @GBB, fair enough. I had a good read into the thread that that the John guy made and lots of people did say it was a scam.

      I guess they will never know until they actually go and find out. Seems like John has what I have - Hidden hearing loss/cochlear synaptopathy as his audiograms were in the normal thresholds. Mine have been too.

      Looks like we are within 5 years till Frequency Therapeutics' FX-322 is released, I am unsure how long the others will take. I know there is Audion with LY305648, Pipeline Therapeutics with PIPE-505 and a couple more but they don't seem to be at the same stage as Frequency Therapeutics.

      There are potential cures/treatments coming, we just have to wait but naturally humans will always want to fix whatever problems they have whenever they can.

      Let me know if you decide to go to South Korea. I did email Minbo Shim and he said he would help but we would need to be quarantined for 2 weeks and a further 2 weeks of treatment. Right now I don't feel comfortable traveling with COVID-19 anyway though.

      What do you reckon with NGP-555? Should I do 100 mg split into 50 mg twice daily for 5 days or 50 mg once daily for 10 days? Just wondering if higher doses at shorter treatment duration is better than lower doses at longer treatment duration.
       
    11. GBB

      GBB Member Hall of Fame

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      I’m not a doctor but John seemed like a fairly objective individual to me. I believe the concepts he was describing seemed plausible and he did seem to get some improvement. That being said without larger data sets it’s impossible to say. My tinnitus has been really bad so for me it might be worth a shot.

      Re: the compound you described, I really have no idea as to the correct duration. I’m just putting together clues/pieces based on the reading I’ve done here as to what might have a shot at working.

      Also just to clarify, I also have clean audiograms up to 8 kHz, but suffer from bilateral high pitch tinnitus and reactivity/distortion. Going on 7 weeks for me.
       
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    12. PauloZ
      Alienated

      PauloZ Member Benefactor

      Location:
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      Tinnitus Since:
      06/2015, got much worse in 09/2019
      Cause of Tinnitus:
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      Good question, I couldn't find it either.
       
    13. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
    14. weab00
      Gloomy

      weab00 Member Benefactor

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      So do you guys think that synaptic regeneration combined with hair cell regeneration will remedy hyperacusis? I’m dealing with horrible ear distortions and am starting to lose hope.
       
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    15. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Distortions and loudness hyperacusis? I think so.
       
    16. GBB

      GBB Member Hall of Fame

      Location:
      NYC
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      Cause of Tinnitus:
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      I personally think distortion is cochlear hair/synapse damage, so am hopeful FX-322 will be a fix.
       
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    17. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
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      Yes, I do. I am confident that these new drugs will help you.

      Please keep in mind that hyperacusis often does get better, it's just freaking slow.
      Protect your ears from hurtful noise and don't lose hope.
       
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    18. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

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      Hi Paul, 4 people went to South Korea.

      John went twice but had no changes in his audiograms and had experienced silence prior to going. Turmeric seemed to help him.

      3 other people went, 1 it did nothing for. 2 got worse from the trip, as in worse tinnitus and one had an infection and ear drum issues because of the amount of injections.

      I wrote Stephen Heller from the Heller Institute at Stanford who said there are no scientific basis for what Dr. Shim was doing and Dr. Shim lied about receiving training at Stanford.

      Wait for real drugs from transparent sources.
       
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    19. paul mclean

      paul mclean Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      falling asleep with headphones in on loud
      Hey thanks for that. Right now it isn't an option for me though. I am looking into oral NGP-555 to see if I can restore some synapses to cope in the meantime while waiting for FX-322 and PIPE-505.
       
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    20. GBB

      GBB Member Hall of Fame

      Location:
      NYC
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      2016-2019 (Mild, Cured) 8/2020 (Severe)
      Cause of Tinnitus:
      Virus / Microsuction / Acoustic Trauma
      Hi,

      Thanks for clarifying this. Could you let me know the two people who got worse?

      Thanks!
       
    21. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
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      Cause of Tinnitus:
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      I recall one member's name was @Tinnitard and the other was a guy named Aldo. Both were commenting towards the end of the thread and have subsequently disappeared I think, as members do.

      Minbo Shim is a scammer, don't let desperation fool you. He's totally not transparent, has published 0 in medical journals or anything serious concerning PRP, and after John went he doubled his prices anticipating a wave of sufferers. The other place doing PRP injections is in India and looks rather dubious as well. FX-322 is the first hearing regeneration drug with results that are substantiated. Are you familiar with Sanford and Steven Heller?

      Like I said, before going John's tinnitus was sometimes silent, which is a good indicator that it will fade in time. Mine is not. I followed the thread for ages and engaged with everyone on it, including Minbo Shim.

      Aldo got an infection from the injections and had an MRI done in South Korea which really screwed him further, no idea how he is now. The other member, Tinnitard (?), or whoever (you'll need to read through say the last 15 pages of that thread), said he was worse and disappeared from the forum. GlennAZ was the man who had bad hearing loss and no change from the treatment.

      If you are Christian you may like that Minbo Shim prays for you after he has given the injections according to 2 members who visited.

      Your profile says you have had tinnitus since 2020... if you can hang in there, that would be good.

      Even @Contrast, our in-house anti-scammer, I believe would concur with my thinking.
       
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    22. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
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      Cause of Tinnitus:
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      I know nothing about chemistry. Please be careful brother.
       
    23. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I wouldn't be touching this uncontrolled stuff either. Essentially it is better just to wait for the regulated medicine to come out which will resolve the issue and which will be tested and proven. Particularly when the wait might not be too much longer and most importantly it will be safe.
       
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    24. wwtsai
      Assassinator

      wwtsai Member Podcast Patron Benefactor

      Location:
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      Looks like they've added additional testing sites for their PIPE-505 Phase I/II: California, Utah, and North Carolina. I'm debating on applying since one site is near Los Angeles where my parents are but bothersome tinnitus is an exclusion criteria.

      Regarding cochlear synaptopathy, is it only present in HHL or can it be present in high-frequency SNHL?
       
    25. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I imagine you could lose your synapses anywhere in your cochlea but if you have an abnormal extended audiogram, that could show hair cell loss (but doesn't exclude also having synaptopathy).

      I.e.: one does not exclude the other.
       
    26. patorjk

      patorjk Member Benefactor

      Tinnitus Since:
      2008
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      I haven't paid much attention to PIPE-505, but after reading through this thread it sounds exciting. However, I'm left with a hand full of questions:

      * How is it that Pipeline Therapeutics and Otonomy can reach the apex of the cochlea, but FX-322 can't? Are Pipeline Therapeutics and Otonomy using the same hydrogels? Did they both just develop one better than Frequency Therapeutics? Or do we not know why Frequency's drug isn't able to reach deeper?
      * Is there any indication of how this will compare to OTO-413? I saw someone got an email from someone at Pipeline that said PIPE-505 preforms better than NT3, but I think Otonomy tested BNDF (OTO-413) against NT3 can saw better results too.
      * Should we be alarmed at the theory that PIPE-505 depletes some of the support cells? Or is this not a big deal?
      * Can both OTO-413 and PIPE-505 get fast tracked?

      I'm assuming if OTO-413 sees good results, it will mean good news for all of these synaptic repair type drugs, since it'll show this is an avenue worth pursuing.
       
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    27. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
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      1) I don't think the problem is a "better hydrogel" as I think both OTO-413 and FX-323 use the same surfactant for one (polyaxomer 407). I believe it's probably that FX-322 binds to what it encounters first, which is why repeat dosing should be much more effective.

      The difference with Otonomy is also that they have an extended release formulation which slowly releases drug from the middle ear, so you are essentially getting a higher dose for longer of drug.

      I'm not sure if PIPE-505 is extended release or not.

      2) I suspect the only way to know would be to compare trial data.

      3) I asked Dan at Pipeline Therapeutics about this and he said the depletion was very little in pre clinical studies and it didn't seem significant.

      Keep in mind, PIPE-505 repairs very little OHCs and that's not the main target of the drug so it makes sense that only a small amount of support cells would be depleted. That being said, maybe someone else can email them and ask for specifics (since I have bugged them enough).

      4) I would assume so.
       
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    28. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I had a look at PIPE-505 and they are currently doing a Phase 1b/2a clinical trial which should be completed by March 2021 but results may be delayed.

      Couldn’t PIPE-505 be released earlier than OTO-413 if the next phase for PIPE-505 will be the pivotal phase?
       
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    29. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
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      I don't see how the next PIPE-505 trial could be pivotal unless there is something that I haven't seen.
       
    30. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      I wasn’t sure if they are doing both Phase 1b/2a clinical trial at the same time as it was stated that they will be done in March 2021.

      If they are, and if similar to FX-322, if they get Fast Track and Breakthrough Therapy status I thought maybe they can go to the pivotal phase after they are done with the Phase 1b/2a clinical trials for PIPE-505.
       
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