Frequency Therapeutics — Hearing Loss Regeneration

#3,241
Don Tinny said:
Like you, I would inject that drug into my ears tomorrow. I do not think there is an adverse effect more horrible than severe tinnitus.

However, what they tell us about "the drug leaves your body in XX hours" does not guarantee its innocuousness.

I stopped taking finasteride (for baldness) 18 months ago, and I still experience horrible fluctuations in my libido. I remember reading that the drug left the body in a few days, however the damage is apparently done.
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Maybe if you got on Clomid or something to boost your sex hormones you'd get boners again? I don't think FX-322 is going to harm you in anyway though. It's working with the body, not against it like 99% of drugs do. Treatments come with side effects; cures, cure.
 
#3,242
Considering hearing loss and tinnitus is the #1 leading disability in war veterans, the government and the FDA need to look at this with an urgency and have this out before 2020.

All questions can be answered by then, if money is there.
 
#3,243
JohnAdams said:
Don't we already have that?
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It can always get worse. Once it can't possibly get any louder, its pitch can change in such a way so that it is even Harder to ignore...
JohnAdams said:
All questions can be answered by then, if money is there.
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The money will be spent in accordance with the State Religion. The State Religion doesn't care about the vets.
 
#3,245
#3,249
Deathtotinni said:
Maybe if you got on Clomid or something to boost your sex hormones you'd get boners again? I don't think FX-322 is going to harm you in anyway though. It's working with the body, not against it like 99% of drugs do. Treatments come with side effects; cures, cure.
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When I left the drug they injected Testoviron and I did not notice any positive effect. Testosterone no longer works properly in the body.

Post Finasteride Syndrome is unfortunately a medical enigma, perhaps even more than tinnitus.

I am happy to have returned to a functional level and have been able to support my partner and my family. But I recognize that I am no longer the same. Anyway, I took it 2 and a half years.

The case of the FX-322 is completely different since it is something short.
 
#3,252
Street Novelist said:
When the hell are they releasing the results? First it was December; now it's January.
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They are certainly aware that their product has a potential to help tinnitus sufferers. I guess they just dont know how desperate for answers we are. Simple question. Did any of the trial participants report a reduction in tinnitus? Please tell us. What's the big deal? Will the universe impload if they simply tell us that?
 
#3,253
Street Novelist said:
When the hell are they releasing the results? First it was December; now it's January.
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I did say a while back that you would not hear anything in December. The latest news suggests it could be anytime in the first half of this year.

Here's an excerpt from a news article:

The company is slated to publish top-line data from an ongoing Phase I/II study of FX-322 in the first half of the year.

You can read more about the latest venture round here:

https://www.drugdeliverybusiness.co...utm_campaign=Drug_Delivery_Business_TrendMD_0

and here:

https://www.businesswire.com/news/h...eutics-Completes-42-Million-Series-Financing/
 
#3,254
Chestnut94 said:
Long term side effects? How much do we need? Can we repeat the treatment or is it a one shot opportunity?

I hate my tinnitus and hearing loss, but I really want to be sure that it's safe and sound and most of all as effective as possible. I wish that for everyone here.
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There is no way of measuring long term side effects without it taking a very long time. I think we will just have to be happy when any treatment comes around. Long term side effects might show up in 30 years. I for one am NOT going to sit around and wait for those assessments when a treatment becomes available.

If it's a one shot opportunity or not is something we can't know. Heck, we don't even know if it is going to be any at all. The drug hasn't even been tested on humans with regards to tinnitus yet! We all have one shot as it is now (when we're born) and many people that are around at this forum, including me, blew ours. I would still be happy though, even if it is just one more.
 
#3,256
JohnAdams said:
Considering hearing loss and tinnitus is the #1 leading disability in war veterans, the government and the FDA need to look at this with an urgency and have this out before 2020.
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I feel your urgency, but 2020 is a little keen, considering its 2019 and we still haven't seen one iota of evidence indicating any sort of clinical efficacy on human hearing or tinnitus.

The tinnitus community actually needs an influential, paid lobbyist to work the halls and offices of Congress. That is how Washington works. Every self interested group with financial capacity is in there working the room.

I imagine what could be achieved if rather than pointing a cross and wooden stake at the mention of the ATA or BTA, they could be co-opted and petitioned to pool a portion of their financial resources along with those advocating on behalf of the hard of hearing, military vets etc., to collectively fund a high profile lobbyist to act on behalf of all stakeholders. That is, assuming a treatment presented itself as viable and suitable for fast track status.

I know, it's a tall order. But as it stands now, the tinnitus community seems to be a highly frustrated, powerless and fractured group of individuals. And it gets us nowhere.
 
#3,257
This from their press release (my italics):

Proceeds from the financing will support the advancement of the Company's clinical candidate, FX-322, for hearing regeneration. Top-line results from an ongoing Phase 1/2 study are expected in the first half of 2019. The financing will also support the continued expansion of Frequency's pipeline with new therapeutic applications from the Company's PCA Regeneration platform.
 
#3,258
Street Novelist said:
When the hell are they releasing the results? First it was December; now it's January.
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Whenever the hell they choose I guess. The San Antonio trial hadn't even finished as of a couple days ago. When they do release the results, it will probably be a summary only. And anyway, they kind of released the results when they said in their last press release that they look forward to phase 2 in 2019. That strongly implies that the phase 1 trial looks to be achieving its endpoints.
 
#3,259
Fabrikat said:
I feel your urgency, but 2020 is a little keen, considering its 2019 and we still haven't seen one iota of evidence indicating any sort of clinical efficacy on human hearing or tinnitus.

The tinnitus community actually needs an influential, paid lobbyist to work the halls and offices of Congress. That is how Washington works. Every self interested group with financial capacity is in there working the room.

I imagine what could be achieved if rather than pointing a cross and wooden stake at the mention of the ATA or BTA, they could be co-opted and petitioned to pool a portion of their financial resources along with those advocating on behalf of the hard of hearing, military vets etc., to collectively fund a high profile lobbyist to act on behalf of all stakeholders. That is, assuming a treatment presented itself as viable and suitable for fast track status.

I know, it's a tall order. But as it stands now, the tinnitus community seems to be a highly frustrated, powerless and fractured group of individuals. And it gets us nowhere.
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No man we just have to wait for a corporation to figure out a way to make huge profits on some drug that doesn't disrupt existing markets too much. We should really just sit down and shut up and not even think about it.
 
#3,261
Perhaps the test subjects are still reporting improvement in hearing and Frequency Therapeutics had to postpone sharing of their results until it stops improving ;-D
 
#3,262
Steven__ said:
I used to post research information on Facebook tinnitus groups but got little response/got comments that there will never be a cure etc.

I don't know if it's just me but it seems like a lot of them there like to drown in their negativity instead of addressing their issues.

I gave up and left when a lot of them said they wouldn't be willing to donate to research, or at least spread awareness.
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People with that attitude are basically arseholes.

I'm a great believer in the Law of the Universe, seen it play out more times than I've ever seen anything from any religion and these arseholes are ruining the vibe.
 
#3,263
Street Novelist said:
When the hell are they releasing the results? First it was December; now it's January.
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I am not sure what kind of results people are expecting as it's only safety trials that are being completed. I doubt that much more is said than that it has proven to be the well tolerated, safe, etc.

The important news is that they managed to get 42MUSD new funding from investors who have had access to all the clinical data to date. That means there is a good probability it is successful and we can be confident they continue to go ahead after releasing safety results.
 
#3,264
Bill Bauer said:
The money will be spent in accordance with the State Religion. The State Religion doesn't care about the vets.
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I agree with you, the terminology you use is a give away, are you an ancap/voluntaryist?
 
#3,265
Mr Mister said:
I am not sure what kind of results people are expecting as it's only safety trials that are being completed. I doubt that much more is said than that it has proven to be the well tolerated, safe, etc.

The important news is that they managed to get 42MUSD new funding from investors who have had access to all the clinical data to date. That means there is a good probability it is successful and we can be confident they continue to go ahead after releasing safety results.
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Well, phase 1/2 is supposed to combine safety and efficacy testing, right? But I agree with you, I doubt we'll get very much from their next report(s), but who knows. just check their site every 7 minutes like I do.
 
#3,266
Here is what we will probably learn form this trial:

Primary Outcome Measures:
  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: Day 15 ]

Secondary Outcome Measures:
  1. Time-concentration profile of FX-322 in plasma [ Time Frame: Baseline, Day 1, Day 2 ]
    Blood samples to be collected within the first 24 hours of dosing to measure drug concentration in the circulation.
 
#3,267
Mr Mister said:
I am not sure what kind of results people are expecting as it's only safety trials that are being completed.
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I think most of us want to know whether or not the drug works, and then whether or not it can help us specifically.

I expect if it turns out the drug is safe but doesn't actually do anything, people will be less than pleased.
 
#3,268
Mr Mister said:
I am not sure what kind of results people are expecting as it's only safety trials that are being completed. I doubt that much more is said than that it has proven to be the well tolerated, safe, etc.
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As far as I understand, this is not the case with a Phase 1/2 study. A Phase 1 study is safety only, but a 1/2 is a combined study to skip ahead and get initial efficiency results as well.

Would the investor(s) of 42MUSD jump onto this after only seeing a safety profile from the ongoing trial? Maybe, but I think we a cash-injection like that, they've been shown more.
 
#3,270
JohnAdams said:
Here is what we will probably learn form this trial:

Primary Outcome Measures:
  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: Day 15 ]

Secondary Outcome Measures:
  1. Time-concentration profile of FX-322 in plasma [ Time Frame: Baseline, Day 1, Day 2 ]
    Blood samples to be collected within the first 24 hours of dosing to measure drug concentration in the circulation.
Click to expand...
I believe both of these outcomes have been very clear and positive in the pre-human trials, right?
 

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