Sorry, not sure what you mean, but I just don't understand all the hype with Fx as if they are in phase3 and we know from people participating that it's 100% success. I started to lose my hearings 4 years ago and I remember the same hype back then, just different companies no one even remembers now. I wish I am wrong....
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Sorry, not sure what you mean, but I just don't understand all the hype with Fx as if they are in phase3 and we know from people participating that it's 100% success. I started to lose my hearings 4 years ago and I remember the same hype back then, just different companies no one even remembers now. I wish I am wrong....
MemberYou might be wrong, you might be right.
Luckily the past year a lot of work is done in this field. Look at this summary e.g. A lot of recent developments mentioned.
Definitely not an earth shattering update, but Phase I of FX-322 has been officially "Completed" and closed out administratively on the on the government's clinical trail website as of April 12th:
https://clinicaltrials.gov/ct2/show/record/NCT03300687?cond=FX-322&rank=1
We already knew this based on their corporate press releases at the end of December, but I'm just noting here that there was some slight movement administratively, so hopefully this is a good sign that the Phase II trial index will be posted soon on the clinical trials website.
https://clinicaltrials.gov/ct2/show/record/NCT03300687?cond=FX-322&rank=1
We already knew this based on their corporate press releases at the end of December, but I'm just noting here that there was some slight movement administratively, so hopefully this is a good sign that the Phase II trial index will be posted soon on the clinical trials website.
Interesting tidbit, and apologize if I'm wrong here, but I was perusing Australian search engines (where Phase I took place) and came across a news release talking about both Audion and Frequency. Here's an excerpt:
"FX-322 involves a one-off injection into the ear of a slow-release gel, which allows the active medicine to gradually seep into the inner ear over the space of a few days, to increase the time that progenitor cells are exposed to the drug — and potentially improving the chances of success."
This is the first time I've read anywhere that FX-322 will be exposed to the inner ear over the course of 3 days. This is in line with the duration in their cultured experiments that produced significant results. If this excerpt is true, and their slow release gel can achieve exposure times of this magnitude, then this is a tremendous feat in regards to Frequency's delivery technology in and of itself (Hi-Five Langer).
Here's the source (pg 3):
https://www.nfd.org.nz/assets/International/One-in-Six-24-Jan-2018.pdf
Audions update has nothing new, but the article seems to suggest efficacy testing is already well under way. The clinical trials website currently doesn't support that assertion, but then again, it takes them several months to update basic information. Either way, take from it what you will. I also find it interesting that these articles never explicitly state it's Audion, but we all know it's Audion.... because we all know too much at this point.
"FX-322 involves a one-off injection into the ear of a slow-release gel, which allows the active medicine to gradually seep into the inner ear over the space of a few days, to increase the time that progenitor cells are exposed to the drug — and potentially improving the chances of success."
This is the first time I've read anywhere that FX-322 will be exposed to the inner ear over the course of 3 days. This is in line with the duration in their cultured experiments that produced significant results. If this excerpt is true, and their slow release gel can achieve exposure times of this magnitude, then this is a tremendous feat in regards to Frequency's delivery technology in and of itself (Hi-Five Langer).
Here's the source (pg 3):
https://www.nfd.org.nz/assets/International/One-in-Six-24-Jan-2018.pdf
Audions update has nothing new, but the article seems to suggest efficacy testing is already well under way. The clinical trials website currently doesn't support that assertion, but then again, it takes them several months to update basic information. Either way, take from it what you will. I also find it interesting that these articles never explicitly state it's Audion, but we all know it's Audion.... because we all know too much at this point.
Interesting talk/interview with David Lucchino (Frequency CEO) from the Alliance for Regenerative Medicine Conference:
Two interesting hearing-related bits emerge
1) The plan is for a Phase I/II trial in the US in the second half of 2018 in the target patient population. The I/II isn't surprising. They will need to test safety in the patient population. This likely means this trial will be small.
2) Their measure of success is a 10 dB improvement in hearing.
Additionally, they seem very aggressive about IP with patents on actual pathways rather than just the small molecules themselves. They also seem pretty focused on hair loss (alopecia).
Two interesting hearing-related bits emerge
1) The plan is for a Phase I/II trial in the US in the second half of 2018 in the target patient population. The I/II isn't surprising. They will need to test safety in the patient population. This likely means this trial will be small.
2) Their measure of success is a 10 dB improvement in hearing.
Additionally, they seem very aggressive about IP with patents on actual pathways rather than just the small molecules themselves. They also seem pretty focused on hair loss (alopecia).
10 dB is a good improvement of course, but I thought that was close to the margin of error on an audiogram.
You mean alopecia, not cochlea hair cells, right?
It is - is test re-test variability is +- 5dB so this is at that edge. I have seen people say that 10 dB shows a significance difference, and I have seen people say that 10 dB is still within that variability so you can't be sure until you hit 15 dB. He says 10 is considered clinically meaningful. Hopefully he is setting a low bar that he thinks they can clear.
I do indeed, I didn't want to look up how to spell it. Since you did, I will edit my post!
If 10db is the bare minimum for clinical relevance, then it doesn't shock me at all that this is where the bar is set. If you think about it from a business perspective, why set the bar higher than you have to? This only increases your risk.
To me, the new million dollar question has become: what happens when you utilize multiple applications of this drug? This unfortunately wasn't even remotely addressed here in this video, but this is a natural question to arrive at when you think about this critically. It pains me that they are pursuing a 1 application procedure. Given what we know about supporting cells, if they can regenerate a 10db improvement in the first place with the supporting cells present, and given the fact that the original supporting cells stay present after they've been duplicated and differentiated, then why not pursue a 2 application or 3 application method? Logically, this can happen based on the whole premise on their drug model and how it works.
Lastly, it pains me that they are pursuing alopecia.... hair loss is a perceived problem, not an actual one. Hearing loss & tinnitus.... now that's an actual fucking problem.
- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
Excuse my ignorance but is tinnitus treatment mentioned officialy by Frequency to be one of the objectives of FX or is it only hearing loss ? And tinnitus is only TT members wishful thinking?
But doesn't Phase I/II also mean that once it's finished, we would know if the treatment works at all? Because otherwise they wouldn't be able to decide what is the best dose if there wouldn't be any results at all.
I think this is right. Presumably they have been talking to the FDA, and this is something FDA has signed off on. I also hope that they consider this a low bar.
They have been sticking to the one application story. At the moment, that also helps contrast their approach with Audion's. One issue that is not surprising, but is disappointing is that it appears the procedure is more effective at low frequencies than high. Not surprising because there is typically more damage at high frequencies. So for someone with mild hearing loss at low frequencies but moderate or worse at highs, you might fully restore low frequency hearing with a marginal effect on high. What happens on a repeated application? Does the body understand the low frequencies have been restored, or does the process continue to generate supernumerary hair cells associated with low frequencies? This may sound good to people here, but I'm pretty sure it isn't though I can't find the paper I have in mind.
Frequency is attempting to restore hearing. The hope is that this will at least help with tinnitus, but that's not the primary goal. I would assume tinnitus will be a secondary outcome if it is mentioned at all.
This is driven by the science. I'm sure they would be happy with a more effective treatment. Pricing will be interesting, because compared to individualized cell therapies, this will be cheap to produce and administer.
It seems almost certain that it would be easier to improve mild hearing loss, but it seem unlikely to me that that would be the target group. Much easier to argue that the true unmet need is at the more extreme end of the scale. We simply won't know until the inclusion criteria are announced.
I've been saying for awhile that Frequency is a company built around a tool, not a hearing loss company. That is becoming much more clear over time. In fact, in the video Lucchino says "We didn't start life trying to be a hearing regeneration company and that's not who we are, that's our first program". Now we did learn that they have outsourced at least some of the work on alopecia to Sinclair labs. I expect that they are outsourcing some of their other work as well. That is the only way such a small company could pursue so many indications at once.
It will slow things down, but I am not sure it is a major blow. He still talked about a proper Phase II starting in 2019 though that assumes no issues with the I/II. I'm guessing this is coming from the FDA. I'm guessing - and this is pure conjecture - that the FDA wants some safety data in the actual patient population. It likely means 1 patient treated, a delay to watch for any safety issues, a second patient treated, etc. It will be interesting to see if they are using the Phase II portion to test dosage or other trial parameters to inform the larger Phase II trial.
It will be too small to "know if the treatment works at all".
Even in the case that the treatment doesn't help with tinnitus, and we just get a 10 dB or more of our hearing back. That in and of itself is huge for the tinnitus community.
This is because then the researchers can scratch one major thing off their list that they know isn't the problem and don't need to work on anymore.
If that would happen then they can redouble their efforts in parts of the hearing or brain where they do think the crux of the problem now is instead of the lost hair cells.
This is because then the researchers can scratch one major thing off their list that they know isn't the problem and don't need to work on anymore.
If that would happen then they can redouble their efforts in parts of the hearing or brain where they do think the crux of the problem now is instead of the lost hair cells.
Here's an interesting talk that Will McLean gave on March 20 at a conference hosted by Sartorius. Mclean was a finalist for "The Sartorius & Science Prize for Regenerative Medicine & Cell Therapy". Unfortunately nothing really new - just mentions that work in live animals is on-going. No mention of trial, etc. It is, however, a more detailed discussion of what was in last year's paper, so it might be helpful if you want to better understand the paper - and the overall process.
The video is embedded on Sartorius' web site, and I haven't been able to get it to link nicely here. So here is the link to the page: https://promotions.sartorius.com/rxf2018/# You need to scroll down and find Will's name. Click on it, then click on the video on the right (the interview is short and doesn't say much).
The video is embedded on Sartorius' web site, and I haven't been able to get it to link nicely here. So here is the link to the page: https://promotions.sartorius.com/rxf2018/# You need to scroll down and find Will's name. Click on it, then click on the video on the right (the interview is short and doesn't say much).
I think technically +10db is 3x louder, so kind of quite a significant achievement. It's not resembling to the 3x hearing improvement in humans though.
The only disappointment from video is that it turns out they have only 23 full time employees. I hope they will team up with someone to bring the treatment to the market, else we will be waiting very long.
On the bright side if they fail with hearing loss treatment perhaps they will help with my hair loss as I have very little left of those as well
The only disappointment from video is that it turns out they have only 23 full time employees. I hope they will team up with someone to bring the treatment to the market, else we will be waiting very long.
On the bright side if they fail with hearing loss treatment perhaps they will help with my hair loss as I have very little left of those as well
Thanks Aaron, always nice to see how you come up with information/links little bit more hidden on the web.
As you mention nothing really new, though I like the last question and the comment, it gives some re-assuring/comfort I always am looking for (though off course we know nothing for sure). But the question was related to the regeneration, in the test done 16 hours after "killing" haircells with AB, and it re-generated within days. But with test taken from deceased patients, they were able to see similair result (where damage occured earlier in life).
@Aaron123 thank you. This is an excellent find. I've been following this thread for 2 years now and I just recently joined, but I just want to sincerely thank you for the contributions you make to this thread/community as a whole. Your efforts don't go unnoticed and I hope you don't plan on leaving any time soon.
If I may, how do you find these gems? I have every single scientist on Frequency's website saved in search engines under multiple different countries, and this didn't pop up at all. The only reason why I'm asking is I want to help.
Side note: you mentioned a concern for the production of supernumerary hair cells as a result from FX-322 application, but since Frequency isn't actually forcing the conversions/differentiation of hair cells, but forcing the mechanisms that gave rise to the hair cells in the first place to do their job one last time, wouldn't this dispel any mishaps from happening that would result from supernumerary hairs cells being made in the first place? Since all frequency is doing is taking these cells back to a slightly more plastic state and bringing them forward again, if your inner ear didn't have supernumerary cells the first time around, why would it happen the second time around?
I think the paper you might be thinking of was from 2017 and was called: Supernumerary human hair cells—signs of regeneration or impaired development?
@Aaron123 Some people in the comments here suggested the 10 decibel improvement was because FX-322 was given to an animal with profound hearing loss and they expect that moderate/mild hearing loss would have much better results due to more progenitor cells being available.
Is there reasons to believe there will be more then a 10db improvement on moderate/mild hearing loss?
Is there reasons to believe there will be more then a 10db improvement on moderate/mild hearing loss?
Rubenslash
Member
Why is everyone focused on the 10db? Thats the treshold set by FDA and Frequency, not the expected inprovement..
Interesting video!
Just strange, that he didn't mentioned FX-322 Phase I/II in the last what's next screen. I thought they should go further with human trials.
That video was recorded in March and the announce about phase I/II came in late April so that's probably the reason.
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Me too, but I´m not exactly sure why.
They get more funds, great, but I´d like to see something substansiell happening soon.
They get more funds, great, but I´d like to see something substansiell happening soon.
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