And phase 2 and phase 3 take an average of 5-7 years so we'll be waiting a while to know if it works.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
MemberWhat I don't understand... When a famous person slips a fart, it's all over the news. The fact that FX completed Phase 1 trials with groundbreaking technology, would be worth an article in a newspaper, one might think. Though I can only find two sites reporting on the press release of FX. Why is there not more media attention for such breaktroughs?
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Andrei90
Member
- Dec 12, 2017
- 154
- 34
- Tinnitus Since
- 12/2017
- Cause of Tinnitus
- Exposure to loud music (earphones)
Since phase 1 is done, should we be hearing about results sometime soon? Or was another aspect of the procedure tested?
That depends on how fast they will push on towards phase 2. I think because they have several competitors breathing down their neck that it will be a case of moving towards phase 2 sooner rather than later.
Last February they told us 12-18 months for the trial.
Since the phase 1 trial has been a little delayed I guess it will probably start around the 18 months mark, so at the end of this year.
Since the phase 1 trial has been a little delayed I guess it will probably start around the 18 months mark, so at the end of this year.
this is very true, I was thinking the same thing, if Bill Gates got tinnitus today they definitely would find a cure for it tomorrow
Only tolerance of the human body. Dont even think the efficiency of reaching the cochlea is measured.
From what I understand, Frequency's delivery method tested in Phase 1 is not ground breaking technology. It's been done before. Also, I think it's a good thing that they are not distracted by media attention at the moment. Now if Phase 2 is successful, that's a whole different ball game...
The number of competitors matters much less than the ability to meet with the FDA or other authorities, agree on the structural of the trial, get approval for the plan, find sites, set up the mechanics, etc. This isn't something that Frequency gets to do all by itself.
This was a phase 1 trial, not a breakthrough.
In fact, the concentration of FX-322 in the Perilymph (and in the rest of the body) were either primary or secondary outcome measures depending on which trial registry you look at. This was discussed Frequency's press release: "In addition, we found that FX-322 successfully diffused from the middle ear to the perilymph fluid in the cochlea with minimal systemic drug exposure." "Further, we were able to confirm the bioavailability both locally and systemically." The mentions of systemic exposure seem a bit contradictory. In the case of the ear, you want minimal systemic exposure.
Beyond that, there are a number of interesting things in the press release that do not appear to have been discussed yet:
1) It looks like they did discuss the results at the US-Japan Symposium on Drug Delivery Methods (https://www.tinnitustalk.com/thread...g-loss-regeneration.18889/page-27#post-295115): "Preliminary results were presented at an invited lecture at the US-Japan Symposium on Drug Delivery on December 17, 2017 "
2) They are in fact working on diseases beyond hearing loss: "The successful study in Australia validates our groundbreaking approach and sets the stage for our development of more progenitor cell activators for additional disease indications." and "these promising results bode well for the continued development of FX-322 for hearing restoration and other potential PCA™ therapeutics to address additional disease indications." and "to tackle a wide range of disease indications where no effective therapeutic solutions are available". On the one hand, this is a good thing in general and good business practice. On the other hand, exploring other indications necessarily takes resources away from hearing loss.
3) Not sure how literally we should take this, but we might have an indication of the inclusion criteria for the next trial (emphasis added): "This successful trial lays the groundwork for future trials in patients with moderate hearing loss who are not candidates for the cochlear implant and whose hearing can be studied over time." Moderate hearing loss is loss of 40-70 dB.
I'm still interested to know why the trial stopped with 9 rather than 13 subjects. It seems likely that they got all of the information they thought the needed. It looks like they may not have done the 1/2 to 2 hours before surgery group - assuming the groups were listed in order in the registry entry. So perhaps they learned all they needed about the diffusion of FX-322 to the inner ear from the 12-24 and 3-5 hour groups.
Try doing an ultra high frequency test, I did one and have a major drop in my hearing from 12khz. My tinnitus is also in this range.
I wonder if this FX-322 is in the inner ear for a long time.
Does Perilymph fluid "flow" through the inner ear? Thus gets "refreshed".
Also, what happens with the perilymph fluid when someone receives a cochlear implant? If you make a hole in the cochlea for implanting this hardware, perilymph fluid will leak out.
What happens if this FX-322 does what it is designed to do. Regenerate hair-cells. Why will it not do this in this instance?
It will not, if with the procedure of implanting, all the perilymph fluid is leaking out together with the FX-322 compound.
But we will not know because researchers are not monitoring this?
This trial is all about safety and see if it diffuses through the round window.
Does Perilymph fluid "flow" through the inner ear? Thus gets "refreshed".
Also, what happens with the perilymph fluid when someone receives a cochlear implant? If you make a hole in the cochlea for implanting this hardware, perilymph fluid will leak out.
What happens if this FX-322 does what it is designed to do. Regenerate hair-cells. Why will it not do this in this instance?
It will not, if with the procedure of implanting, all the perilymph fluid is leaking out together with the FX-322 compound.
But we will not know because researchers are not monitoring this?
This trial is all about safety and see if it diffuses through the round window.
Am I being too optimistic hoping this will be a miracle for all of us? Hyping that it will be in like 5 years. When the reality is that most clinical trials fail, hair cell regeneration might not cure tinnitus, it might only work half ass. A daunting 15 year wait, The price will be extreme, FDA loves halting things. The odds are against a dream cure but I'm still staying positive as Frequency Therapeutics may be our only hope and it may be true that competition will bring us closer to a cure.
Sometimes i wish i didn't know about frequency at all, it just endless stream of "this must be it, i ll hear music like i used to someday" and "the odds are just so low" changing every few days.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Well, look at the increasing prevalence of hearing loss and tinnitus through veterans, wars, MP3 players, social events etc.
This is only going to work in our favour, there is a huge demand for this and not only that, there is little that can done for senatorial hearing loss (just hearing aids to amplify) and nothing, for tinnitus.
Estimates from the WHO that come out with things like a billion people are at risk is only going to speed things up.
Of course, the FDA need to approve these things but that's a good thing, nobody wants to get worse with these injections and nobody wants to get sued. We're all hoping for a good outcome.
I'm one hoping this treatment would be available in 5 years but the reality is it's probably gonna be closer to 10 years before it's ready for the masses. Still it's something giving us hope. There are several companies racing to develop this treatment with a $20 billion market and lots of the smartest scientists engineers and doctors working in this. It will happen it's just gonna take some time to get there.
I am confused and certain peoples comments are giving possible mis-information.
I have three questions.
1: Is Phase 1 complete or is just part of phase 1 complete?
2: Why are the people still getting cochlear implants when this can potentially cure them?
3: Is there results if this improves hearing loss and or tinnitus?
I have three questions.
1: Is Phase 1 complete or is just part of phase 1 complete?
2: Why are the people still getting cochlear implants when this can potentially cure them?
3: Is there results if this improves hearing loss and or tinnitus?
Complete
They are getting CIs because they need them and this treatment is not available. It is possible the treatment will help them though it is not knowable given they are having surgery and because it is not possible to image the inner ear.
No.
Not sure what you view as misinformation. Statements made by company representatives and in press releases should be met with a healthy dose of skepticism. In the cases where a company or university releases a press release, it can be quite enlightening to read the paper after reading the press release. The press releases frequently oversell the "discovery". That is misinformation.
I should note that in this case I don't view the successful completion of the phase 1 trial in this same light. There doesn't seem to be any reason to doubt that the trial is over, that they had no adverse events due to the drug, and that they were satisfied with what they saw in the diffusion of FX-322.
From what I can tell, the main unknown in how long it might take for FX-322 to reach the market if the trials are successful is the length of the phase 2 and phase 3 trial. This is likely not completely under the control of Frequency. I'm assuming the effect of the treatment, if any, would be apparent relatively quickly. The question is how long the FDA would want the trial to be to look for any safety issues. The FDA and/or other agencies will have a say in the trial design.
Can't they give the patients an audio gram and simply ask them if they have less perception of tinnitus?
Like is there a way to take actual pictures of hair cells in the inner ear before and after?
They could, but they also got a CI so it would be meaningless.
They did ask to see if it worsened - this is one of the adverse events that apparently didn't get worse, but again, they subjects had CIs implanted so it is meaningless.
No.
Bottom line is we have to wait for the next phase.
Why did they administer the treatment 24 hours before cochlear implantation? I would think it would be more prudent to do so a week or two before just to get an idea of the efficacy of the drug. The one part of this that makes absolutely no sense to me.
This was not a trial to judge efficacy. The reason for administering the drug at different time periods prior to surgery was to sample the perilymph at the time of surgery to judge the diffusion from the middle ear to the inner ear.
Thanks, I understood that this was simply a safety trial but wondered why they wouldn't at least be curious to see if the drug showed any (unofficial) effectiveness on hearing loss. But the need to sample the perilymph soon after administration makes perfect sense. Thanks again Aaron.
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