Some encouraging news in these troubling times!
Why do you think they waited until this stage to do the exploratory study? Wouldn't they want to know before Phase 1 or 2a to see if it even makes it into the cochlea?Yes, it was separate. From the link:
"The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany. Results were based on an analysis of cochlear fluid, known as perilymph, obtained intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.
"When we consider these new findings, together with the hearing signal observed in our earlier Phase 1/2 study, we believe we have developed the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic. Through this study we have gained critical insight into the delivery properties of FX-322 and clinical confirmation that it reached the site of action in all study patients," said Carl LeBel, Ph.D., Frequency's Chief Development Officer."
Not mention tinnitus even once.Some encouraging news in these troubling times!
They only just started testing for tinnitus in Phase 2a. We will know more around October when they release results.Not mention tinnitus even once.
I know. This product is intended to cure hearing loss, not tinnitus. In their phase 2a trial, they will however investigate the effect of FX-322 on tinnitus! Unfortunately nothing on hyperacusis.Not mention tinnitus even once.
They essentially did the same study already on explants. This is just more data using perilymph analysis which appears to be a new method.Why do you think they waited until this stage to do the exploratory study? Wouldn't they want to know before Phase 1 or 2a to see if it even makes it into the cochlea?
Already bought a bunch of FREQ stock. I am banking on their success for multiple reasons!This is why I believe Frequency will make a huge impact. David CEO, Jeff, Bob, and Will etc. The company has all the right people to make it work.
Anyone buying any stock?
You need an extended audiogram to assess this better.There is something I'm unclear on, and I'll use myself as an example:
It seems, going by online frequencies generators that I can only hear up to around 9250-9500 Hz. After that I can't hear any frequencies. Does this mean that I will never be able to get any of this hearing back even with FX-322? Once it's totally gone, it's gone for good?
I'm not doing the podcast. I just submitted ideas for questions and helped w wording. Frequency is not contacting me. That's a question for the mods. I do know there is still a COVID-19 related delay and I'm sure when they know more, they will announce it.Recently suffered from SSHL (totally deaf in right ear) and been following this board for a few months. Awesome info guys!! 2 quick questions... FGG have you had a call with Frequency yet? I know you were gathering questions for Tinnitus Talk Podcast. Second I too would like to know if you guys have bought stock and if so how much? If this makes it through phase 3 the stock will go through the roof! Thanks again for all the info.
Yeah, I realise all that, but as I understand it there has got to be some level of hearing still there, ie see FGG's post.It's supposed to restore lost hearing, especially in the higher frequencies, so no, not gone for good. Whether it reduces tinnitus is still unproven but one can infer that it would. The debate lately has been about how low the frequency restoration would extend, so the high frequencies would definitely be covered and that's where most hearing damage occurs.
I have a loss of 50 dB at 8000 Hz, which is moderate hearing loss, but then as I said at 9250-9500 Hz I hear nothing, but like you said I need to get my hearing checked properly.You need an extended audiogram to assess this better.
Frequency reportedly addresses up the moderately severe losses. Otonomy have a drug in pre-clinical for severe losses but that's probably 5-8 years away.
By the time you have profound losses, though, you have often lost too many support cells for this approach. There are some researchers working on profound losses, though. I corresponded with one who said it could be 15-20 years away, however because you have to first regenerate support cells (and their correct architecture) from so called "Flat epithelia". I have profound loss at my apex and around 13kHz and higher so I probably have to wait 15-20 years to hear music again, assuming my KV3.1 channels and/or strial potassium channels aren't an additional hurdle. High dose Azithromycin toxicity is the devil.
At this point, I'm mostly cheering the rest of you on. I have semi given up for my own situation given just how destructive prolonged high dose Macrolides are.
We'll see if I make it until then.
I would think you'd have to treat the area your tinnitus is in to be effective.Yeah, I realise all that, but as I understand it there has got to be some level of hearing still there, ie see FGG's post.
I have a loss of 50 dB at 8000 Hz, which is moderate hearing loss, but then as I said at 9250-9500 Hz I hear nothing, but like you said I need to get my hearing checked properly.
Theoretically then, my tinnitus could then be in the range were I have no hearing, although an ENT suggested it maybe at the dips of 4000 Hz and 6000 Hz on my audiogram. Would improving my hearing <9500 Hz still have some effect on my tinnitus if it is caused by hearing loss above 9500 Hz? I find it hard to match my tinnitus to a frequency online.
Here we are waiting for a drug to help us, but it was drugs that in our case got us in this predicament in the first place.
Couple of comments as someone with a finance background, six figure amount invested in the market and always happy to give some investing advice:I was thinking about buying Frequency Therapeutics stock just like @F-u-T.
How much do you think is reasonable to buy Into a biotech with no other drugs in their pipeline and their success being banked on FX-322 alone?
I know it's a very difficult question to answer, but in terms of investing money, I think it's sensible not to let your emotions get in the way (every single person reading this is rooting for their success not because they are invested, but because it may cure their hearing loss and tinnitus).
Also, I know far too well that this is a first of its kind, hearing restoration is something new and was once thought as an irreversible condition (yet to be proved it's reversible). I also know that tinnitus is incredibly stubborn and baffled researchers for years and years. I have read a lot and I have witnessed failure after failure.
Also, I remember when Auris Medical went public and it was 5.00 a share and now it is 1.07 a share. I really thought about investing in them not solely to profit, but because I was rooting for them to succeed. I never did invest though.
On a more positive side, it is obvious to Tinnitus Talk readers across the world that this is the company where their science makes the most sense. Not only that, but PCA can have have other benefits beyond hearing loss.
@Greg Sacramento I would appreciate your knowledge in trading your opinion and also @attheedgeofscience with your financial background.
I know all answers are speculation but it would be great if 3 great things happened; a cure for hearing loss, a cure for tinnitus and a little bit of money made.
Also, if you were going to invest, how much would you bet on this company? I figured that I would know when to pull out (stop-loss) because I literally keep up to date with the ear regeneration therapies all the time.
They are still recruiting at all the sites i believe but some may have a temporary hold on start time due to COVID-19. I would call and ask.Does anyone know if they are still taking patients in the Colorado Springs testing site?
I have the same thing at high frequencies and assume it's a combination inner hair cell loss and outer hair cell loss. Mine goes to profound loss in this range, which means i have lost all cell types, including support cells per a researcher I spoke to (she said "by the time you are in the profound range, you are left with "flat epithelia in that area."). This same researcher said those in the profound range are more likely to wait 15-20 years for treatment (vs other types which already have drugs in trial). Hopefully that isn't the case for you too but get an extended audiogram if you can.@FGG or anyone else that knows this:
When doing a sine sweep or using a tone generator, I "feel" the highest frequencies more than I can "hear" it as a tone, except at the end when the tone stops. There isn't much of a perceptual volume change even as the volume goes up. This occurs mostly in my left ear. What kind of damage is this?
Not odd at all. I would give both legs, my sight and all of my assets to have music back.Thanks! I think I might buy 1000 shares. If it makes it I win in two ways! Oddly enough I would rather have my hearing back in my ear than have $100k+. Thanks again.
Even if that researcher is correct, the good news is that anti-aging science and technology like CRISPR is coming a long way! I really think we're going to see our lifespans grow drastically in the next few decades...I have the same thing at high frequencies and assume it's a combination inner hair cell loss and outer hair cell loss. Mine goes to profound loss in this range, which means i have lost all cell types, including support cells per a researcher I spoke to (she said "by the time you are in the profound range, you are left with "flat epithelia in that area."). This same researcher said those in the profound range are more likely to wait 15-20 years for treatment (vs other types which already have drugs in trial). Hopefully that isn't the case for you too but get an extended audiogram if you can.
Different protocols? Did she give any indication as to what she meant by this?It looks like they are still recruiting in Colorado Springs. Interestingly the woman I was talking to expected there to be additional studies of different. FX-322 protocols in the near future.
What did she mean by that? Phase 2b?It looks like they are still recruiting in Colorado Springs. Interestingly the woman I was talking to expected there to be additional studies of different. FX-322 protocols in the near future.
I've never had an extended audiogram, but I've looked up the thresholds in dbSPL and used an app that kind of functions as an extended audiogram. I'm nearly certain that if I did have an extended audiogram to 16kHz, it would be normal.I have the same thing at high frequencies and assume it's a combination inner hair cell loss and outer hair cell loss. Mine goes to profound loss in this range, which means i have lost all cell types, including support cells per a researcher I spoke to (she said "by the time you are in the profound range, you are left with "flat epithelia in that area."). This same researcher said those in the profound range are more likely to wait 15-20 years for treatment (vs other types which already have drugs in trial). Hopefully that isn't the case for you too but get an extended audiogram if you can.