Pipeline Therapeutics
- Thread starter FGG
- Start date
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...
paul mclean
Member
- Sep 8, 2020
- 77
- 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.
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.
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.
It seems that the drug is quite expensive too though if it is bought from a foreign source.
paul mclean
Member
- Sep 8, 2020
- 77
- Tinnitus Since
- 2018
- Cause of Tinnitus
- falling asleep with headphones in on loud
Member- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
- Apr 28, 2019
- 5,452
- Tinnitus Since
- 01/2019
- Cause of Tinnitus
- Multi-factorial
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.
paul mclean
Member
- Sep 8, 2020
- 77
- 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.
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.
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.
- Jul 15, 2020
- 23
- Tinnitus Since
- 06/2015, got much worse in 09/2019
- Cause of Tinnitus
- Loud noise exposure, both times.
paul mclean
Member
- Sep 8, 2020
- 77
- Tinnitus Since
- 2018
- Cause of Tinnitus
- falling asleep with headphones in on loud
- Apr 28, 2019
- 5,452
- Tinnitus Since
- 01/2019
- Cause of Tinnitus
- Multi-factorial
I personally think distortion is cochlear hair/synapse damage, so am hopeful FX-322 will be a fix.
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.
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.
paul mclean
Member
- Sep 8, 2020
- 77
- 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.
Hi,
Thanks for clarifying this. Could you let me know the two people who got worse?
Thanks!
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.
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.
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?
Regarding cochlear synaptopathy, is it only present in HHL or can it be present in high-frequency SNHL?
- Apr 28, 2019
- 5,452
- 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.
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.
* 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.
- Apr 28, 2019
- 5,452
- Tinnitus Since
- 01/2019
- Cause of Tinnitus
- Multi-factorial
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.
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?
Couldn't PIPE-505 be released earlier than OTO-413 if the next phase for PIPE-505 will be the pivotal phase?
I don't see how the next PIPE-505 trial could be pivotal unless there is something that I haven't seen.
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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