Frequency Therapeutics — Hearing Loss Regeneration

[Fightthearmy]

"I believe the clinical trial system is broken," said Janet Woodcock, who has worked at the agency for more than three decades, at an industry panel on Nov. 14. "I do not believe it serves the interests of patients."
https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/

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.

 

[JohnAdams]

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!

 

[Pero1234]

Dude, why don't you just go and straight up work for Frequency Therapeutics. You're living encyclopedia on the field

Plottwist... he already is

 

[RB2014]

I have sent my resume.

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

 

[JohnAdams]

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.

 

[Fightthearmy]

I'm guessing that although they saw improvements, they weren't as robust as they wanted and that they now need to test multiple doses, which is what the next phase will test. Getting the dosage and the dosing schedule right may take a very long time, unfortunately, fast track or no fast track.

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 *

 

[WickedCarnival]

Hopefully they concentrate on dosage and not schedule, because that could take a long time. It might also be different for different people.

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:

 

[JohnAdams]

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:

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

 

[john paul]

^^^ eventually it will happen.

 

[Fightthearmy]

^^^ eventually it will happen.

EVENTUALLY you'll be six feet under.

 

[Aleksa Uzunovic]

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?

 

[tomytl]

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:

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.

 

[Stoie]

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.

 

[d'Wooluf]

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

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.

 

[JohnAdams]

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.

 

[Aleksa Uzunovic]

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.

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

 

[85dB T]

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

 

[85dB T]

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

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.

 

[David Dorci]

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

 

[Gorbeh3]

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:

Thank you for contacting Frequency Therapeutics, and we appreciate your interest in our company. Frequency Therapeutics develops small molecule drugs that activate progenitor cells within the body to restore healthy tissue. Progenitor cells are the natural sources of tissues throughout your body and remain present through adulthood. Through the transitory activation of these progenitor cells, Frequency enables disease modification without the complexity of genetic engineering. Our therapies use proprietary combinations of small-molecule drugs to cause dormant progenitor cells to multiply and create new cells.

Please be aware that it is important that you not discuss your condition with anyone at our organization. We take very seriously the privacy of all individuals that may be participants in ongoing or future clinical trials that we sponsor, as we are legally bound by the rules as set forth in the 1996 HIPAA act. We encourage you to discuss your condition and your interest in trial participation with your healthcare providers, since your potential candidacy is based on their medical evaluation of your health status. Please appreciate that we are not able to discuss this matter with you any further based on the information we've provided herein.

Again, at this time we are unable to provide you with any additional details on the status of our programs. As Frequency Therapeutics is a privately held biotechnology company and not a medical provider, Federal Regulations prohibit the sharing of any information between our two parties. If you would like to stay informed about Frequency Therapeutics and any ongoing clinical trials evaluating our drug candidates, please refer to www.clinicaltrials.gov. You may search by disease, location of clinical trials, or by the name of the company sponsoring the clinical trials. Additionally, you can reference the latest press releases available on our website www.frequencytx.com for information regarding upcoming or ongoing clinical trials. Thank you again for reaching out and we wish you well.

 

[Piney]

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

 

[meirzhu15]

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

 

[Graig]

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.

 

[tarmaced]

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:

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

 

[hopeful4future]

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.

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.

 

[bell]

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

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

 

[RB2014]

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.

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.

 

[andreimatei]

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

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...

 

[swc5150]

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.

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.

 

[tarmaced]

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

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