Are you sure about removing the eardrum and drilling the hole with laser? According to study information, the drug is administrated via intra-labyrinthine infusion and so more like syringe needle injection. While still invasive, but recovery time should be much shorter with not much side effects due to delivery method at least.
Thanks for the clarification.
Yes, CGF-166 involved some surgery. There was this video with the first patient to receive the drug:
Thanks for posting John Queen, welcome to the forum.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 opinion here.
So, after a not-very-careful reading of that document, I only see encouraging results. Let me explain...
1. The first thing I noticed is that, for ALL the patients that received the drug, the dose seems to be the same, but in different volumes (0.05 mL and 0.2 mL). What I mean is that those who received the 0.2 mL injection hadn't had more of the drug, but more of the vehicle substance, to increase the volume (probably in the eventuality that a higher volume would diffuse better in the cochlea). I say this because they state: "[...] similar results were obtained with both dose volumes. This is consistent with published work showing drug delivery to the cochlea depends more on the concentration of the drug than the volume of injection."
So, if I'm right, the actual drug dose was <0.05 mL, so a really, really small dose.
2. In my opinion, even with that small dose, the results are simply spectacular. Keep in mind that the drug first reaches the high-frequency region of the cochlea; then, have a quick look at the patients' health profiles. Also, keep in mind that the audiometry scores were recorded only up to 8 kHz, so the really high frequencies were not included. Let's get to the patients profiles and word recognition (WR) scores: there were a few with mild SNHL and a few with moderate to moderately-severe SNHL. Those with mild SNHL probably had good WR scores already and good hearing up to 4-8 kHz, so leave those out. Six had worse SNHL *and* were also treated. Out of those six, four had statistically significant improvements in WR. If you look at the numbers, they got approx. 100% improvement (some even more!). That's a damn good improvement for a very small dose in a safety study! [I would kill for 100% improvement in word recognition.]
And if you look at the aggregated results -- treated vs. placebo --, there's a 30% improvement. For me, that's more than acceptable.
They even stated that four of those six worse-SNHL-guys had a 10 dB improvement at 8 kHz and, if that's not due to chance, it's also spectacular.
3. It might be possible that not all the drug reaches the target supporting cells, especially since the dose was so small.
Maybe there would be more things to say, but I'll stop here.
To sum up, these results are exactly how I would expect them to be. You won't see a +50 dB improvement in audiometry scores at 0-8 kHz with less than 0.05 mL of the drug.
I have some hopes with this company and their drug. Just don't get too stressed and wait for the Phase 2 results.
Have a good day, guys!
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 increase the volume. If you ask me, this situation would be a bit counterintuitive, but it's not impossible. It's not clear, for me at least, from that document or from what can be found on clinicaltrials.gov, what exactly have they done: did they give the same drug quantity to everyone or did they keep the concentration fixed and increased the volume... but either way, the drug quantity is small, and I expect much better results in Phase 2.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 opinion here.
So, after a not-very-careful reading of that document, I only see encouraging results. Let me explain...
1. The first thing I noticed is that, for ALL the patients that received the drug, the dose seems to be the same, but in different volumes (0.05 mL and 0.2 mL). What I mean is that those who received the 0.2 mL injection hadn't had more of the drug, but more of the vehicle substance, to increase the volume (probably in the eventuality that a higher volume would diffuse better in the cochlea). I say this because they state: "[...] similar results were obtained with both dose volumes. This is consistent with published work showing drug delivery to the cochlea depends more on the concentration of the drug than the volume of injection."
So, if I'm right, the actual drug dose was <0.05 mL, so a really, really small dose.
2. In my opinion, even with that small dose, the results are simply spectacular. Keep in mind that the drug first reaches the high-frequency region of the cochlea; then, have a quick look at the patients' health profiles. Also, keep in mind that the audiometry scores were recorded only up to 8 kHz, so the really high frequencies were not included. Let's get to the patients profiles and word recognition (WR) scores: there were a few with mild SNHL and a few with moderate to moderately-severe SNHL. Those with mild SNHL probably had good WR scores already and good hearing up to 4-8 kHz, so leave those out. Six had worse SNHL *and* were also treated. Out of those six, four had statistically significant improvements in WR. If you look at the numbers, they got approx. 100% improvement (some even more!). That's a damn good improvement for a very small dose in a safety study! [I would kill for 100% improvement in word recognition.]
And if you look at the aggregated results -- treated vs. placebo --, there's a 30% improvement. For me, that's more than acceptable.
They even stated that four of those six worse-SNHL-guys had a 10 dB improvement at 8 kHz and, if that's not due to chance, it's also spectacular.
3. It might be possible that not all the drug reaches the target supporting cells, especially since the dose was so small.
Maybe there would be more things to say, but I'll stop here.
To sum up, these results are exactly how I would expect them to be. You won't see a +50 dB improvement in audiometry scores at 0-8 kHz with less than 0.05 mL of the drug.
I have some hopes with this company and their drug. Just don't get too stressed and wait for the Phase 2 results.
Have a good day, guys!
I don't think it is negativity to be disappointed when a hearing loss drug has no impact on audiogram.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 opinion here.
So, after a not-very-careful reading of that document, I only see encouraging results. Let me explain...
1. The first thing I noticed is that, for ALL the patients that received the drug, the dose seems to be the same, but in different volumes (0.05 mL and 0.2 mL). What I mean is that those who received the 0.2 mL injection hadn't had more of the drug, but more of the vehicle substance, to increase the volume (probably in the eventuality that a higher volume would diffuse better in the cochlea). I say this because they state: "[...] similar results were obtained with both dose volumes. This is consistent with published work showing drug delivery to the cochlea depends more on the concentration of the drug than the volume of injection."
So, if I'm right, the actual drug dose was <0.05 mL, so a really, really small dose.
2. In my opinion, even with that small dose, the results are simply spectacular. Keep in mind that the drug first reaches the high-frequency region of the cochlea; then, have a quick look at the patients' health profiles. Also, keep in mind that the audiometry scores were recorded only up to 8 kHz, so the really high frequencies were not included. Let's get to the patients profiles and word recognition (WR) scores: there were a few with mild SNHL and a few with moderate to moderately-severe SNHL. Those with mild SNHL probably had good WR scores already and good hearing up to 4-8 kHz, so leave those out. Six had worse SNHL *and* were also treated. Out of those six, four had statistically significant improvements in WR. If you look at the numbers, they got approx. 100% improvement (some even more!). That's a damn good improvement for a very small dose in a safety study! [I would kill for 100% improvement in word recognition.]
And if you look at the aggregated results -- treated vs. placebo --, there's a 30% improvement. For me, that's more than acceptable.
They even stated that four of those six worse-SNHL-guys had a 10 dB improvement at 8 kHz and, if that's not due to chance, it's also spectacular.
3. It might be possible that not all the drug reaches the target supporting cells, especially since the dose was so small.
Maybe there would be more things to say, but I'll stop here.
To sum up, these results are exactly how I would expect them to be. You won't see a +50 dB improvement in audiometry scores at 0-8 kHz with less than 0.05 mL of the drug.
I have some hopes with this company and their drug. Just don't get too stressed and wait for the Phase 2 results.
Have a good day, guys!
You don't normally keep escalating a drug dose until you get the "maximum safe dose". That's something that cannot be known before testing.
There are actually people working on changing the status quo. Per Janet Woodcock at the FDA (she's written a lot about this recently), the "bottom 1%" of reckless drug companies kind of ruined it for everyone and the regulations are written around them more or less.
Yes, both safety and efficacy are not fully confirmed until all phases of the trial are complete.
In phase 2A they will test the effect of up to 4 injections over a time period. No mention of the dose though. Might by the high dose tried the previous phase. So there is a new element of risk and safety will still be checked but will not be the purpose of the tests. That is what I make of it!
The question is does Frequency Therapeutics truly believe in FX-322? The IPO value of the business would be at least 10 times higher after completion of successful phase 2 so from financial perspective it doesn't make sense to IPO it on the verge of a presumed breakthrough. Current owners have deep pockets and they could easily finance phase 2 without an IPO. Development would be faster without all the burden that comes from added regulations and requirements of a public listing.
IPOing now gives more value to investors since the increased value of the stock would be "priced in" after phase 2.
It's probably even more complicated than that; in some studies, loudness and distress seem to arise from disparate, but related and highly connected brain regions. IIRC, gray matter deficits in the right anterior insula, caused reliably worse distress ratings among people who had been matched for volume ratings. On that note -- long-term meditators show increased gray matter density in this same brain region, which once again provides an interesting but uncorroborated mechanism by which cognitive practices may literally retrain the brain at a physical level to handle the tinnitus signal better.
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