Coleoptere
Member
It is.... as you need 500 - 1.500 mg for a dose. If someone wants to experiment I suggest to open a thread under "Alternative treatment research".
Hough Ear Institute's Hair Cell Regeneration Project
- Thread starter all to gain
- Start date
Coleoptere
Member
As for early access to trials. The FDA responded swiftly. No surprise they referred me to their right-to-try website:
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
New for me is that there is also an option expanded access for life threatening or very serious situations:
https://www.fda.gov/news-events/public-health-focus/expanded-access
(Fortunately) we are not eligible for these options.
So we have to beg Hough Ear Institution for access (in an upcoming trial)
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
New for me is that there is also an option expanded access for life threatening or very serious situations:
https://www.fda.gov/news-events/public-health-focus/expanded-access
(Fortunately) we are not eligible for these options.
So we have to beg Hough Ear Institution for access (in an upcoming trial)
Member- Oct 3, 2019
- 167
- Tinnitus Since
- 1983
- Cause of Tinnitus
- My sister, and a firecracker
Great question. I don't know exactly, but I believe we still have 7 or more years left on it. Sometimes they can be extended, but that's a legal question for which I am wholly unqualified for
!Yes, our hope is to get Dr. Rick Kopke or Dr. Matt West, and maybe myself, on the Tinnitus Talk Podcast. They know the science behind this like no other. I'm just a guy trying to spread awareness and get to a treatment or cure.
- Oct 3, 2019
- 167
- Tinnitus Since
- 1983
- Cause of Tinnitus
- My sister, and a firecracker
Another great question. I must say I love the thoughtfulness and civility of nearly everyone on this thread and these forums. It is quite refreshing. I'll try to answer everyone as quickly as I can. The only thing preventing me from being more active is my other job responsibilities, a lovely wife, and 7 children!
Funding comes from Government grants and private donations. What has happened in the last 3 years or so is that our data has outpaced government funding. What that means is that we have had many breakthroughs and successes from a research perspective, that we find ourselves needing funds to continue to advance the research faster than the government funding process provides.
We want to treat people and relieve their suffering as soon as we possibly can!
I believe we will get the funding needed for this research and others. We have a very compelling mission, our research team and their data are top-notch, and we are trying to increase awareness around the globe. The cost of hearing loss and tinnitus to the world is too high.
Things are somewhat on hold until funding comes through. Our researchers have to work on projects that are funded. For example, we could have been in Phase II clinical trials already, possibly be done with them - had we had the funding necessary to move it forward.
- Oct 3, 2019
- 167
- Tinnitus Since
- 1983
- Cause of Tinnitus
- My sister, and a firecracker
I'm trying my best to answer questions the best I can with the limited time I have. I'm on here on a Saturday trying to share instead of spending time with my family. If that doesn't come across as authentic - then I suggested you serious look at "why" you "feel jaded".
I didn't say I wouldn't discuss it, just that it is too long in a forum's format. Everyone on here is coming from a different perspective. I don't know how much everyone knows and whether their information is accurate, about the FDA approval process and how drugs gets commercialized. To start from the very beginning would be way too long to post. Hopefully, on the Tinnitus Talk Podcast we can answer that question more in-depth.
Maybe you missed my response to @ajc. No worries. I will say this - we are talking with biotech firms currently to take the pill to market. It's a long process and a private one for what should be obvious reasons.
Let me ask you a question or two: Why do you think big pharma might not want to invest millions of dollars in a drug that has completed Phase I studies? Why would they be more interested after Phase II?
Great question. I don't know exactly, but I believe we still have 7 or more years left on it. Sometimes they can be extended, but that's a legal question for which I am wholly unqualified for
Yes, our hope is to get Dr. Rick Kopke or Dr. Matt West, and maybe myself, on the Tinnitus Talk Podcast. They know the science behind this like no other. I'm just a guy trying to spread awareness and get to a treatment or cure.
It looks like very few people are in this thread, at the moment. However, we are wondering, if there is a way for us to somehow use your patented Tinnitus drugs, while they are still being tested in the clinical trials? Could this be a possibility, in any near future? Some of us are desperate for help, and the current available treatments seem to be rather disappointing.
- Oct 3, 2019
- 167
- Tinnitus Since
- 1983
- Cause of Tinnitus
- My sister, and a firecracker
You don't have to beg
! The best way to learn about upcoming trials is to sign up for our newsletter. We don't share, rent, or lease out private information. It is in our newsletter, and Facebook page, where clinical trials and the protocols for them will be announced along with how to sign up for them!
- Oct 3, 2019
- 167
- Tinnitus Since
- 1983
- Cause of Tinnitus
- My sister, and a firecracker
Unfortunately not. This is for everyone's protection. The drug may not work. The drug may have complications with other drugs that we are currently unaware of. The FDA process while frustrating is set up to ensure that we are protected AND that someone doesn't sell us snake oil.
@Justin De Moss I just want to thank you for being present and answering questions.
This is a group of sufferers of varying degrees. Being angry, jaded, depressed, frantic, etc etc are all part of the territory.
But you being here makes a difference. It gives us hope.
If this drug fails, let it be a public failure that contains great lessons for all the researchers fighting the good fight against tinnitus and hearing loss. WHEN we cure this, it will be one of the greatest achievements of man kind, returning massive quality of life to millions the world over.
Keep going.
This is a group of sufferers of varying degrees. Being angry, jaded, depressed, frantic, etc etc are all part of the territory.
But you being here makes a difference. It gives us hope.
If this drug fails, let it be a public failure that contains great lessons for all the researchers fighting the good fight against tinnitus and hearing loss. WHEN we cure this, it will be one of the greatest achievements of man kind, returning massive quality of life to millions the world over.
Keep going.
Yes there actually is. You would have to either fake a lab and get a chemical supply company to ship you some HPN-07 or get a contact that is associated with a medical lab, even at a university, to use their credentials to do the same.
It looks like the drug is combined with NAC, which is readily available at supplement stores and online. You would have to do some research to figure out the doses. What I am saying is that the drug is out there and it is within the realm of possibility. The same can be said for the types of chemicals that Frequency Therapeutics and Audion are using, but those also require an intratympanic injection which you would need someone else, with experience like an ENT (or possibly a veterinarian
) to administer for you because self administering an intratympanic injection would be very very difficult and risky.Perhaps you wouldn't even need to buy it, as it can be synthesized. This would take an advanced knowledge of chemistry as well as the recipe for the drug and that may be the impossible part of the puzzle unless you can look at the molecule and figure out how to replicate it. Hey, people make LSD.
Why am I envisioning this as a sequel to Breaking Bad?Perhaps you wouldn't even need to buy it, as it can be synthesized. This would take an advanced knowledge of chemistry as well as the recipe for the drug and that may be the impossible part of the puzzle unless you can look at the molecule and figure out how to replicate it. Hey, people make LSD.
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Coleoptere
Member
Good point! Although I fully agree with the FDA's intentions many people do not see why it has to take so long and why we accept that while people suffer. Once a medicine is commercially available it is already 10 year's old technology. Combinations with other medicines is a very rightfull concern but we do not see that back in the test setups. I assume side-effects are measured on the flight. So I assume it should not prolongate testing (unless issues are found).
It needs reforms in the FDA to conserve these goals while speeding up the approval process. That's why right to try, expansion, fast lane and break through is added to their processes but it is still painfully slow.
Thanks for your information on the Hough Ear Institution site. I'm reading it!
Because he mentioned (twice) finding a mob doctor type veterinarian to do this for one
...Btw a lot of things are similar between humans and animals but ear canal shape is not one of them (maybe if you found a primate vet). It also, presumably, has to be angled correctly towards the round window. I would say finding an overseas ENT is a much better option if you go this route than a veterinarian even if you could find one to risk their license.
The plot thickens. You are the mob doctor vet, I knew it. You'll be brilliant, I will be one of the thugs to protect and watch your back FGG.Because he mentioned (twice) finding a mob doctor type veterinarian to do this for one
Btw a lot of things are similar between humans and animals but ear canal shape is not one of them (maybe if you found a primate vet). It also, presumably, has to be angled correctly towards the round window. I would say finding an overseas ENT is a much better option if you go this route than a veterinarian even if you could find one to risk their license.
Charles Michel, who is about to become President of the European Council (together with President of the Commission the most powerful job of the EU), has hearing damage due to a gunshot.
Could you write to them? I know it's a long shot, but I've been writing powerful people with the hope of getting a bite... it's worth ten minutes... thanks.
Well, I found a mutual contact with a research lab that offered to buy some HPN-07 and mail it to me, BUT upon further examination we discovered that it has to be stored at -20 C. The only way to keep that temperature as far as I know is with dry ice, and you cannot put that in a closed container because it will explode the container.
Any ideas?
Any ideas?
If you could get your hands on NAC you can make the pill they are intending to test, a combined pill of HPN-07 (they tested 500-1500 mg) and 1200 mg NAC instead of taking two pills at the same time. Apparently the synergy between the compounds is what causing the magic. Will you get the same synergy with two pills? No idea how to store it. Isn't it easier to transport it directly to a chemist that can make it for you in the lab?
By the way, the fact that people are willing to go to these lengths should tell scientists they need to hurry the hell up. 5-10 years is not gonna cut it for some of us.
Edit: link to the study
https://clinicaltrials.gov/ct2/show/NCT02259595
the constraint is the FDA.
Chances are, one of us is going to find an ENT to inject our ears with BDNF and NT-3. There's a really good chance one of us already has.
I hardly doubt the FDA is the cause of Hough taking 5 years to initiate phase 2 after phase 1. Something else going on there.
Phendran
Member
Some models of freezers here in Sweden cool as low as -30 Celsius without too much trouble. Something like that shouldn't be too hard to find across the seas either I hope.
Oh, yeah. Well, hmmmm. Yeah hurry up Hough, damn. It's like you don't want our money or something.
They probably didn't have the funding or a partner that has the funding to start phase 2. By the way, the patients that got the pill in phase 1 probably have some interesting stories to tell.
Interesting stuff about their injection OPI-001. Apparently it causes both supporting cells to spawn supporting cells and hair cells and to transdifferentiate the supporting cells into hair cells. Sort of a combination of the properties of FX-322 and Regain?
"OPI-001 introduces siRNA to target the repressor molecules, allowing supporting cells to freely express the regeneration of sensory hair cells through transdifferentiation, as well as encouraging the proliferation of supporting cells. (...) We have also investigated the use of a specific class of pro-proliferative compounds to increase the number of supporting cells that are responsive to our transdifferentiative therapeutic strategies with the goal of inducing a more robust regenerative response."
http://otologicpharma.com/the-science/
"OPI-001 introduces siRNA to target the repressor molecules, allowing supporting cells to freely express the regeneration of sensory hair cells through transdifferentiation, as well as encouraging the proliferation of supporting cells. (...) We have also investigated the use of a specific class of pro-proliferative compounds to increase the number of supporting cells that are responsive to our transdifferentiative therapeutic strategies with the goal of inducing a more robust regenerative response."
http://otologicpharma.com/the-science/
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