The only thing about that is that the drugs being delivered would have to be mixed with a ferrous nanoparticle substance, which may or not be ototoxic, it will also dilute the medicine.
Here you go:
I could watch it with a VPN. It was a shit segment to be honest. Local news click-bait pretty much. The summary of it was - phase 1 is done and was successful, phase 2 is starting soon. That's it, so nothing we didn't already know.
https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728
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Just reading the concept of what they want to do is masturbation material. I swear it gets me hyped and horny everytime I read about how they want to regenerate my hair cells.https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728
Frequency Therapeutics is a Massachusetts company hoping to reverse hearing loss using a cutting edge treatment. We first introduced you to the company almost two years ago as it was developing the drug "FX-322."
Humans are born with about 15,000 tiny hairs in each ear, which act like antennas to pick up sound.
Loud noises will kill them off and the human body just throws them away, never to be replaced. Frequency Therapeutics developed a drug they say can convince nearby stem cells to regenerate the destroyed hair follicles. If you can regrow the hair, the belief is you can restore your hearing.
"Really, the goal is to show we can do two things for humans: we can help people hear sound more loudly, and the second half of that is they can hear the sound more clearly," David Lucchino, the co-founder and CEO of Frequency Therapeutics said.
Phase one of the FDA process included injecting 24 patients with a gel during a five minute outpatient procedure last year.
"Phase 1 proved no safety issues and that's all that study was designed to do," Lucchino said. Phase 2 will explore if the drug can be used in multiple doses.
If all goes well, Frequency Therapeutics plans on asking the FDA to fast track the drug, citing recent studies that link hearing loss to other diseases like depression and dementia."
- They are claiming phase 1/2 was just a "phase 1" study... nothing about efficacy
- Good news is that it was safe! No hyperacusis or other damage to hearing as some have feared.
- "Phase 2 will explore if the drug can be used in multiple doses." -- I guess one dose had some minor effect, but hopefully the effect will be better from multiple injections?
This could be seen as a negative. Does it mean that the dose they gave didn't do what they had hoped? And why "multiple" doses and not simply one larger dose?
True.
It's absolutely normal to try to find what doses are most effective now that they know it's safe, that's the whole point of the phase they're in so don't worry.
True, the move is a bit weird. But couldn't it also just be one of these "now I'm needed there and my job here is done" -kind of thing? Where the people at the different companies know each other and collaborate to some extent and swap people around when needed/useful.
I agree with your logic to some degree, but I think it's important to note that Frequency Therapeutics for the longest time pushed this whole notion of a single dose administration. They have completely backtracked on this approach. This causes me some concern that the drug isn't as effective as they were hoping for. This kind of signals to me that they're going to plan B in hopes that increasing concentration and exposure to the drug will provide the therapeutic benefits they were hoping the initial signal dose administration would have provided.
It's completely normal that different doses are tried during clinical trials... Yes they wouldn't do that if a single dose restored 100% of the hearing but I don't think anyone expected that?
I get that, but I think what I'm trying to say more clearly is this:
This could indeed be the case. Another thing that made a warning bell go off for me was the "Phase 1 proved no safety issues and that's all that study was designed to do," -quote, which kind of sounds like they he's trying to cover up the fact that it actually was a phase 1/2 study, where efficiency was taken into account to some degree, because the results just weren't good enough to talk about.
Oh my bad. I assumed multiple doses wasn't about several injections but more product injected aka more doses.
You could be right...
When I was in that clinic laying there with goop in my ears I realized that it's not necessarily how much you can inject at one time, but how long it can be in contact with the round window membrane. So if you could use a little and keep it in there longer, that would be better than using a lot that's only in there for a little bit. After my injections he had me lay there with my head perfectly positioned for about an hour every time and I was told not to swallow. Substances injected into the middle ear wash down the eustachian tubes. So if they were injecting a high dose and a low dose and they were only in there for the same amount of time then the essentially I think they would only have had a similar amount of the drug actually diffuse through the round window membrane because that's the bottleneck. Does that make sense?
Probably at the very very soonest 2 to 3 years.
Yes, for the most part.
Do you really think 2 to 3 years? God I truly hope so! I'm scared it'll fail or disappear somehow though. I have faith something will cure us all, but I'm also afraid!
Nothing is for sure, but it is looking like this will in fact recover some hearing loss, and that will likely have a positive impact on tinnitus. The mere fact that they are still moving along with it and getting investments is a good indicator.
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