They could still expand patient populations in Phase 2b or Phase 3, depending on what they find in Phase 2a with tinnitus as a secondary outcome measure. But tinnitus in itself is still widely seen as a symptom of an underlying illness instead of a pathology in itself. Your best bet is still piggybacking on a hearing loss drug.
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Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
MemberAwareness is key. Our enemy in this regard is the ATA and BTA. They should be promoting awareness of these types of drugs and they are not.
Agreed.
I was talking to my dad about these new developments, he's spent his life in pharmaceuticals.
He said these are all good things, but the fact that they've gone public and been fast tracked does not mean that their science or results thus far is any better than anything else. Still plenty of room for failure.
The upside being that we're getting more awareness, and more funding being put towards the issue. A positive for us sufferers as a whole, but until phase 2 results are posted, and phase 3 happens with a much larger group - without lots of bad side effects, I won't be quite as excited. Feels good for sure, and it feels like we're on the cusp of greatness... but make no mistake, this is a very profit centered thing.
He told me he's seen companies like this go dead overnight after a bad clinical study. So approach with a guarded heart everyone. We will get there.
He said these are all good things, but the fact that they've gone public and been fast tracked does not mean that their science or results thus far is any better than anything else. Still plenty of room for failure.
The upside being that we're getting more awareness, and more funding being put towards the issue. A positive for us sufferers as a whole, but until phase 2 results are posted, and phase 3 happens with a much larger group - without lots of bad side effects, I won't be quite as excited. Feels good for sure, and it feels like we're on the cusp of greatness... but make no mistake, this is a very profit centered thing.
He told me he's seen companies like this go dead overnight after a bad clinical study. So approach with a guarded heart everyone. We will get there.
I think we all know that failure is a very real and, if we look at the history of hair cell regeneration, the more likely outcome. But I'm excited to see another treatment step up to the plate. Eventually someone is going to hit it out of the park. Why not FX-322?
I find it quite impressive the things they are accomplishing and the rate they're doing it in. Going public, and getting fast tracked. They're certainly keeping the finances healthy. I do wish they were more communicative with the public, like Hough. But all we can do at this point is wait and see.
Yes, I see the IPO and Fast Track more like that the drug isn't demonstrably ineffective. I also remain worried about their delivery method/hydrogel. Too many risk factors that the drug doesn't reach the cochlea.
Here they explain why the hair cells generated by FX-322 are just like normal hair cells, equipped with all that is necessary to communicate with the brain (16:54):
Hair bundles, pre-synaptic ribbons and active transduction channels.
In my opinion, if there will be a problem, it will not be the incapacity of the drug to regenerate hair cells because it's already proven with animals and a human cochlea.
With the intratympanic injection, the drug can fail to reach the cochlea and stay inside it the time necessary to induce the chemical reaction and proliferation. The other possibility is that the hair cells are successfully regenerated but hearing is not returned, in that case we will know that something else is involved in the process of hearing despite hair cells, that we don't know yet. This possibility has low chances of occuring since mice treated with FX-322 regenerated hair cells that allowed them to hear correctly.
There are only 2 clinical trials in humans that haven't posted full results. That's the history.
Hi guy,
I remain dubious about Hough... Donate, donate, donate...? What have we learned from the kind chap who's visited the forum, bless his kind soul.
Half the shit we use everyday at some point came from MIT.
Frequency Therapeutics is coming out of Harvard and MIT and a few other prestigious joints.
Your dad Is very smart and his words resonate with me. Hope for the best but be ready for the worst. He spent his life in the industry, his advice is definitely worth listening to.
"Cautiously optimistic".
I am still a huge fan, but am a little scared my ears will be to fried by the time the goop hits the market.
Still a huge fan and devoted groupie.
I am currently trying to find out where Flamingo1 lives on Google Maps because he's gonna be super rich and I am hoping he'll buy me a coffee.
To be fair to Hough, they may be in OKC but they have quite a bit of national recognition.
I've been talking out of my butt regarding this being a 3 month study. They are taking 210 days for this phase.
https://clinicaltrials.gov/ct2/show/NCT04120116?term=fx-322&rank=2
https://clinicaltrials.gov/ct2/show/NCT04120116?term=fx-322&rank=2
Maybe they want to see the long term effects. Well, e.g. think of laser treatments for vision; eye doctors follow their patients for a year to see if the effects are stable even after a year. Safety is another concern knowing that they are giving multiple injections this time and a higher dose.
Just my 2 cents, let's stay optimistic as it's the one and only option to survive this life.
Maybe they are going biblical and trying to build Noah's ark... 210 days... I am going to source some opium... this is ridiculous. At least our children will be ok. Could they go any slower?
Defiant-Decay
Member
- Oct 1, 2019
- 50
- 26
- Tinnitus Since
- 2019
- Cause of Tinnitus
- Loud noise/ music in headphones
I have a gut feeling that Hough Ear Institute is the way to go with tinnitus treatment, but everyone's so focused on Frequency Therapeutics. I just hope Hough gets the funding they need 
I disagree. I think they may know something we don't. They did just conduct some groundbreaking research and they probably are basing this time frame on something they know firsthand.
Let us know how the opium affects your tinnitus friend.
- Jun 7, 2019
- 37
- Tinnitus Since
- 03/2019
- Cause of Tinnitus
- Overexposure to loud music
Hopefully so! I was just remembering that there are multiple mechanisms (or theorized mechanisms, including mechanisms in the brain) and that one drug or treatment may not be able to cure the tinnitus because it doesn't address them all. As you say, we don't know for sure. Which is why it's great we have a few devices and drugs all being worked on at the same time. The next couple years should reveal a lot about this condition that is still a mystery.
Daniel Lion, dude, I bought a couple of shares of a 12 dollar stock!
This is not https://finance.yahoo.com/quote/GOOG/
I'll still buy you a cup of coffee though in Orlando, Florida.
- Jun 18, 2019
- 294
- Tinnitus Since
- 05/24/2019
- Cause of Tinnitus
- Chronic headphones use and acute noise induced trauma.
Well technically there are synapses and nerves involved in hearing. It's not only about stereocilia. In fact tinnitus is more likely caused by neuropathy and synaptopathy than the actual hair cells dying.
- Jun 18, 2019
- 294
- Tinnitus Since
- 05/24/2019
- Cause of Tinnitus
- Chronic headphones use and acute noise induced trauma.
I am not sure as to what warrants me to be compared to "Dr Death" (not that I am against euthanasia, but I did not help anyone die, that I am aware of), is that some form of personal attack I should be aware of?
How about writing constructive posts instead if that's the case?
Thank you for your insight. Is there a good text or image available explaining the different parts of the inner ear involved in hearing? I hear a lot of terms I can't always place: stereocilia, cilia, nerve endings, spiral ganglion neurons, auditory nerve etc.
Sorry, I was just bitter over your comment about hoping the drug helps my high frequency hearing loss but could give a toss over people with profound hearing loss. Kind of hard not to interpret that comment any other way, but selfish and hurtful.
Ces't la vie.
I will be nice , and start again with peace in my heart. Peace to you, my feelings were hurt, it happens when you have chronic tinnitus and profound hearing loss.
Start again...
Defiant-Decay
Member
- Oct 1, 2019
- 50
- 26
- Tinnitus Since
- 2019
- Cause of Tinnitus
- Loud noise/ music in headphones
You would probably do the same, Hough is a non-profit humanitarian group, and research is very very expensive. If you take the time to read their page they talk about a veteran that has the hearing of an 80-year-old man, this tells me they are not just concerned about slight hearing loss, bur also very profound hearing loss.
I feel like the only reason frequency is so hyped is because it's coming sooner. Donate Donate Donate, isn't this what we should be doing?
The recent tinnitus conference said that funding in research is one of our biggest issues so Hough hasn't been completely inconsistent with what we know...
New article on inner ear delivery methods, co-authored by people involved in the REGAIN trial.
From the introduction:
"The importance of delivery cannot be understated; the success of any novel therapeutic depends on selection of the most suitable method for the pharmacokinetic profile of the individual agent, and the balance of risks associated with delivery against the potential benefit of the treatment"
And:
"Middle ear approaches, such as transtympanic injection, rely on simple diffusion through the epithelial barriers of the round and/or oval window. This can lead to the formation of concentration gradients, with variable concentrations reaching more apical regions of cochlea, and potentially insufficient levels of the therapeutic reaching the basal regions. Delivery using sustained release formulations, magnetically targeted delivery, and nanoparticles aims to overcome these problems, but they remain a significant concern. Intra-cochlear therapeutic delivery offers the best control of delivery at the cost of the highest risk to hearing, although the problem of base-apex gradient formation remains."
https://www.frontiersin.org/articles/10.3389/fncel.2019.00418/full
I think it's safe to say inner ear drug delivery will be the new frontier now that we've discovered multiple therapeutics that might regenerate hearing.
People who are experts on inner ear drug delivery might make for a great podcast episode...
From the introduction:
"The importance of delivery cannot be understated; the success of any novel therapeutic depends on selection of the most suitable method for the pharmacokinetic profile of the individual agent, and the balance of risks associated with delivery against the potential benefit of the treatment"
And:
"Middle ear approaches, such as transtympanic injection, rely on simple diffusion through the epithelial barriers of the round and/or oval window. This can lead to the formation of concentration gradients, with variable concentrations reaching more apical regions of cochlea, and potentially insufficient levels of the therapeutic reaching the basal regions. Delivery using sustained release formulations, magnetically targeted delivery, and nanoparticles aims to overcome these problems, but they remain a significant concern. Intra-cochlear therapeutic delivery offers the best control of delivery at the cost of the highest risk to hearing, although the problem of base-apex gradient formation remains."
https://www.frontiersin.org/articles/10.3389/fncel.2019.00418/full
I think it's safe to say inner ear drug delivery will be the new frontier now that we've discovered multiple therapeutics that might regenerate hearing.
People who are experts on inner ear drug delivery might make for a great podcast episode...
"Be selfish and inconsiderate of others' feelings"? Is that what I should do?
I do donate, and I am not a selfish deuce bag, I donated yesterday and I am poor. A lot poorer than many here who can't cough up ten dollars to keep the forum going. I support three kids and make less than 20 grand a year... Save the lectures bro... You have no idea...
Even with raging tinnitus I always reach out to sufferers, read my posts.
I want everybody healed. Not, hey thanks for the drug and the fix, I am ok, and see you losers later.
I stop and help homeless people and mentally ill people and taught kids for 20 years.
The dude played his cards and was honest... "me first, fuck the rest"
Interpret that how you like, to me it was selfish and mean spirited considering some of us are looking at cochlear implants and have profound hearing loss and chronic tinnitus.
I have no issue with you.
My issue is people who post, "to be honest, I'll be happy to get my ears fixed, but am not really concerned about the less fortunate."
I objected to another forum member's comments. Let's give it a rest... It's done, it's human nature...
Take care
That one Harvard researcher was saying that the nerves miraculously heal once the hair cell is regenerated. Though I agree the tinnitus is most likely more from the nerve damage, if it heals once the hair cell is back then it should improve too.
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