Frequency Therapeutics — Hearing Loss Regeneration

For each one who says the clinical trial system is broken, there are three or more people who think the former are full of cr*p. Hence no speedup.

 

NEAT!

Tell them thanks for approving drugs that gave many of the people here tinnitus!

 

Plottwist... he already is

 

I hope you're serious and I hope you get the job. We need someone in their team batting for us.

 

I'm not elite enough to work for them. I also don't have enough lab experience.

 

So there remains a lot of work left getting the dosage and dosing schedule right. However, they did see *some* improvement. That's a lot more than ANY currently available treatment offers, and presumably for tinnitus as well. But if the FDA says I have to wait til I'm 80 years old to get improvement (even a slight one), then it's no use boasting around how incredibly fast the FDA is, as the FDA executives and David Kessler are doing. * EVERYTHING IS SHIT *

 

I hope they team up with Otomagnetics so that they can get the molecules into the inner ear more effectively, rather than just a crude injection with a needle:

Otomagnetics Magnetic Injection Technology

 

Or this?
https://www.technologyreview.com/s/608252/first-object-teleported-from-earth-to-orbit/

 

^^^ eventually it will happen.

 

EVENTUALLY you'll be six feet under.

 

Maybe the Chinese have some treatment as their system is extremely efficient and they would approve it as soon as the treatment is proven to be safe and effective?

 

I guess delivery is less of a problem than triggering the correct cells in the inner ear to regrow and develop. The Draper Lab has been developing such a device years ago.
But no worries, they work hand in hand. Things are amazing and if there is proof of regeneration with hearing enhancement the future will bring many different approaches.

I guess the next 3 years will show what we can expect in the nearer future.

 

Frequency Therapeutics's press release mentioned "signs of functional hearing improvement" but that could mean a broad range of results, from 3 dB to 20 dB. To my knowledge even 3 dB could make some people understand spoken words better given it doubles the perceived volume.

To be honest sometimes their pitches, articles or rumours seem extremely well put together pieces of PR stuff, promising the moon to some (like some of us folks here) while to the skeptical eye nothing really exact in the event things go sideways.

Guess we have to wait for the statistical data if they will release anything specific of it this year for Phase 1/2.

 

I don't like them particularly either, but I don't feel I really need to. The possibility of things 'going sideways' is just assumed in any clinical trial. They do control the information flow to their advantage. That's to be expected I guess.

The thing is, they have achieved 'functional improvement'. It would be nice if that improvement were large, but even if it were small, it's still a beginning. I'm not sure why it's not all over the news to be honest.

I found something on Reddit from a person who was involved in administration for that particular trial. She said it was the best trial she had ever been involved in and Frequency Therapeutics were great people to deal with. Can't find the link at the moment.

 

I've been in contact with some of the people with Frequency Therapeutics as well and they are very open and actively engaged. They have passion about what they are doing for sure. I don't think this is a typical pharmaceutical company at all. They definitely are fully engaged.

 

Look bruv, I don't give a damn, I'm taking 20 shots of that thing per ear if it works, no big deal.

 

Frequency Therapeutics Announces Positive Phase 1/2 Data for Drug Candidate for Hearing Restoration


Primary safety endpoint met as FX-322 was well tolerated

Preliminary clinical data suggests improvement on measures of hearing function

Company now planning Phase 2 Study to commence later this year

April 09, 2019 07:00 AM Eastern Daylight Time


'https://www.businesswire.com/news/h...Therapeutics-Announces-Positive-Phase-12-Data

 

Conventional experience is only worth so much. They may prefer someone competent, capable and passionate about the opportunity. They can train you their way without retraining inferior skills and techniques.

 

Dear David - thank you for your nice email and sorry to hear about your hearing loss.
Frequency is working to develop a therapy to combat noise-induced hearing loss in this initial study. While we are still some time away from a commercially available treatment, we are working hard to move as quickly as possible to that outcome. The clinical trials will be conducted in 3 separate stages as explained by the National Institutes of Health, but the overall time frame will be dependent on the trial design. You may find further information on how trials are crafted and conducted here: https://clinicaltrials.gov/ct2/about-studies

The cause of tinnitus is not clear in all cases, but this condition is almost always accompanied by hearing loss due to damaged cells within the inner ear. Because of this, regenerating hair cells may be helpful in patient suffering from tinnitus.

Also, in the meantime you can learn about existing clinical studies being performed around the world at the FDA website - here is a link: https://www.clinicaltrials.gov/ct2/results?term=hearing+loss&Search=Search
Please visit this link and enter your contact info to be part of Frequency’s outreach efforts and keep people informed of our progress: http://frequencytx.com/contact/index.php
and any questions you have about Frequency’s study should be sent directly to clinicaltrials@frequencytx.com

With warm regards,
Jeff
Jeff Karp B.Eng. PhD.
Professor of Medicine
Brigham and Women’s Hospital, Harvard Medical School

 

On Friday, I called the number on the website regarding clinical trials and gave them my information, the woman who I was speaking to said I would get an email soon.

I received the following:

 

I got the same. I wonder if my VA audiologist has to call. It’s probably a long shot.

 

Only noise induced hearing loss... not my case.

 

I think they have included sudden hearing loss in many of their postings. The last trial included people with hearing loss due to noise exposure or sudden sensorineural hearing loss.

 

Same response I got when enquiring about UK clinical trials of FX-322.

 

So would genetic hearing loss not be included? I’m not sure if mine is noise induced or genetic. I have about the exact same hearing loss in one ear as my mother but perfect hearing in the other ear as she is deaf in the other ear. I never noticed my hearing loss until after firing a gun and tinnitus started, then went to an audiologist and found out about the reverse slope hearing loss which is very identical to my mom's.

 

Is there going to be an UK clinical trial? I am so interested in what you are saying mate!

 

Mine is genetic as well as noise induced so I am in the same boat. I've read a lot and I don't think there is a clear answer. Usually when they exclude genetic hearing loss they mean your ear wasn't built right at birth. Many people just have bad genes, like myself, that makes the hearing loss in the high frequencies go faster. I think the answer is it should work for us just the same, but right now it is not really known.

 

I believe I saw in some of their videos that it also may help reverse ototoxic medicine damage as well. Did I mishear? Part of my situation is due to this so I am hoping so...

 

Depending on the degree of hearing loss, 3 dB would be definitely be noticeable. 20 dB would be huge! I would love to add 3 dB to my hearing.

 

I know as much as you I am afraid. I knew the reply was a boiler plate response so decided to just wait.