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I can't think of a time frame till it will be available, but with all the recent developments (the partnership with Astellas, FDA Fast Track, new drugs legislation both in US and Japan etc.), I hope not too late. My guess is: around 2 years from now if everything works fine in the trials. But I...

... I bet they'll just recycle some gamma-secretase inhibitor, nothing new. But if they eventually come up with a new idea, well, that'd be great.

Please note that also: the patients in the placebo group had no clinically meaningful improvement whatsoever; the tests were the same. If there was some variation due to memorization or some other factor, I think the results from the placebo group would reflect it. many patients only had mild...

Thank heavens for this. I sent a mail to the FDA last year in which I tried to argue in favor of such a classification, giving examples of how people committed suicide due to conditions that aren't deadly themselves, but significantly alter quality of life. This is a sign that it might get...

Dude, there were 4 patients with +100% (yeah, doubled) word recognition scores. That result simply cannot be due to blind chance. Most of the other treated patients had only mild hearing loss and there was little room for improvement, as someone from Frequency reported. (Moreover, researchers...

“The Japanese want to be the regenerative medicine center of the world” -- that sounds good. Long live the emperor! :rockingbanana: Also, a highlight from the article: The “regen” boom in Japan is based on a series of reforms and new laws for pharmaceuticals, but especially the landmark...

Yes, that's correct. At least, that's what should happen; initially they announced the results will be published on 31/01/2020, but changed that recently, maybe something interesting happened and they need more time to analyze the data.

"A Phase 1b/2a study of PIPE-505 in SNHL is expected to begin in 4Q 2019, with topline results expected in late 2020." Nice, nice. So, by the end of 2020 we should have results from both FX-322 and PIPE-505 trials.

No problem, I'd be happy to try the dose used in the Phase 1/2 study, which is likely safe; I don't necessarily need good efficacy. Now I see... I honestly hope that'll change after this clinical trial. :( Even if they'd ask for a higher price for the drug to cover all the expenses, I wouldn't...

Those of you who are Americans, couldn't you petition to the FDA and engage the Hearing Loss / Tinnitus associations to find a way to include drugs like FX-322 in the expanded access program? It's plain stupid what the FDA does right now, FX-322 actually completed 2 studies (Phase 1 & Phase...

It would work for sensorineural hearing loss, but there are other companies which are developing treatments for genetic hearing loss, if that's the cause.

Woops, you're right. I've got some wrong info. It might be that he's actually McLean.

Awesome invention, looks like we're on the right track... that would mean they will be able to inject the drugs directly in the cochlea, like in an intralabyrinthine injection procedure, which currently is a very hard procedure to do. And oh, the perforation completely heals in one week, that's...

That guy on Reddit (Leviathan or whatever his username was) is not Will McLean, it's a postdoc researcher who worked in Frequency's team.

No, it didn't fail. They just narrowed (or changed) the indications and are continuing the approval process. This is a quite recent video that the company posted.

I think this would be the best option. It should be much cheaper to get the drugs approved in the EU than the US. If I'm not mistaken, you can go through the approval process in one member country (that has less restrictive rules for approval) and then ask for approval in all EU countries. But...

Nope. Nope. Nope. I don't think it works this way. These growth factors probably don't reach the inner ear even if their concentration is increased, it's nothing like locally delivered NT-3 or BDNF. As an example, GABA is a neurotransmitter; it is very important and very active in the brain, but...

Bro, I was just a bit scared for other people's health and pockets. Intratympanic injections with anything are not something to fool with. Maybe the PRP isn't that worrisome, but the stem cells part scares me, because I don't know what's the fate of those stem cells inside your ears.

But it subsided after a while, right? Otherwise, the event should be reported...

Seemed to be permanent, from what that woman was saying. (yeah, I know, it's weird, because the drug is basically a formulation of esketamine, an enantiomer of ketamine) You could also check the Keyzilen fact sheet...

I don't know anything about how effective Lenire is, but at least it's not risky as long as people don't hang themselves with the wires.

I think it worked in a subset of patients who had tinnitus from certain well-determined causes, like traumatic injuries or otitis media, so they reevaluated the indications and continued the studies...

Not really, I'm just cautious. And I try to evaluate therapies based on the available data. Shim's treatment is simply overpriced and unproven. I should edit that: I meant it COULD be dangerous long-term, as it was not tested for safety, I'm not saying it is.

Well, actually you got a few injections with stem cells out of your butt, so idk what to say... (I tried to be polite, sorry.) But fine, go on and convince people to spend thousands of dollars for useless treatments offered by a guy who has no real scientific achievements. For all the others...

My advice: don't waste your money on Shim's treatment. Wait until mid-end 2020 until we have results from studies that test drugs which are much more likely to have a real impact on hearing loss/tinnitus. There's Frequency Therapeutics, Otonomy, Audion, Auris Medical; and Decibel Therapeutics is...

Hey, I see you went to South Korea to that doctor, Minbo Shim. If he offers that PRP + stem cells treatment anyway, can't he offer sustained-exposure BDNF treatments as well (the drug Otonomy is currently testing)?

I'd hug you now if I could. I'm in a similar situation, but I have pretty bad hearing loss (worse than you, in any case), and when there's (loud) background noise I can't hear much. I think what we need is both hair cell regeneration and synapse repair for the surviving hair cells (I see Otonomy...

Eek, so 4 injections, one per week. They will basically know how effective it is after one month, but the study ends September next year... damn, that's unfair. (I know, they want to prove that the effects will last and also record more stuff.) And does anyone know why on Earth would they test...

Yes, that's the downside of using only gamma secretase inhibitors: the number of supporting cells decreases, since those cells turn into hair cells. There was a study in mice (from 2013, I think) where they showed this reduction. The good thing was that the treatment indeed improved ABR scores...

Some guy from Hough Ear said mid (for the pill) to end (for the injection) 2020s, that is, 2025-2029, not mid 2020. +A question: If Hough Ear Institute received enough funding, would they consider drug development in Europe or Asia? It is much cheaper, with less restrictions, as far as I know...

Nope, they will start Phase 2a this year and report the results in 2H2020 (at least that's what they anticipate). After this, if everything goes as planned, they will probably Fast Track it or will receive some other FDA drug status to speed up the process. Anyway, at the end of 2020 we should...

Guys, today I just thought that maybe we should do something to speed up the process and make this drug available faster somehow, and I have two ideas. Some feedback on them would be welcome. 1. I don't know how drug approval works in other countries, but there should be a damn country where...

I think it was an exclusion criteria if your tinnitus is more of a problem for you than the hearing loss, because their aim was to test for improvements in hearing. (That does not mean the drug has no effect on tinnitus, just that they want to prove the drug works for hearing loss in the first...

I think you're right somehow. Later edit: I used the data from that document, and if I'm not mistaken, yes, for the others, the average improvement was around 0.5%. But the others had only mild hearing loss, so it's likely that they had good baseline scores, thus also the improvement would...

Well, until they get the drug approved... Meanwhile in Korea, Russia, China and a few other countries after Phase 2 results will be published:

Any news about their presentation at the AAO meeting? And about FX-322's effect on mid-low frequencies: my guess is that it will reach/affect the corresponding cochlear region if they increase the dose/concentration.

By the way, in early 2020 we should have the results from Audion's REGAIN trial, and that one is in Phase 2 and has a similar mechanism of action as FX-322, so we will have an indicator for FX-322's efficiency. However, FX-322 should be much, much better. The drug used in the REGAIN study is...

LE: There would be a second possibility with the dose -- that the concentration was kept fixed (e.g., 0.1%) and volume was increased, with similar results. This would mean that, indeed, the drug quantity increased, but you would obtain similar results at a certain concentration even if you...

Yes, CGF-166 involved some surgery. There was this video with the first patient to receive the drug: Afterwards, it seemed that the drug actually improved balance more than it improved hearing (at least for that patient). One interesting fact is that the study for CGF-166 was initially...

Hello everyone, I haven't had a Tinnitus Talk account beforehand, but I was following this thread, and I was a bit disturbed by all the negativity that just spread after the release of this document with partial results from the clinical trial, so I decided to create an account and post my...