Inner Ear Hair Cell Regeneration — Maybe We Can Know More

What is the international trial they talk about with the 24 patients that were injected with the gamma-secretase inhibitor? I don't think I had heard of that? They also mention the frequency trials and what they have done up to this point.

Wow.... So it looks like the 24 volunteers only had partial deafness. To me that means healthy volunteers. I guess those will have a chance to regain some hearing. It looks like we will know shortly unlike the trials in Australia where the compound was given to those about to get a CI operation.

 

Yes, it very much sounds like Audion's phase 1/2 trial, because it is conducted in the UK and it uses a gamme secretase inhibitor. Later in the article they talk about frequencies FX-322 trial.

 

So there are two clinical trials of ear regeneration ... great!

 

http://cordis.europa.eu/project/rcn/193313_en.html

 

I just can’t wait until Harvard starts doing their testing this year!

 

Would this work for severe hearing loss? Seems that many of these treatments are limited in terms of how many progenitor or supporting cells one has.

 

plus there are 2 types of hearing cells, one for hearing sounds, other for distinction

 

Probably not, but we don't know for sure yet. As you say, you need to have enough progenitor cells for the treatment to work (if it works at all).

 

What about Columbia University Herbert and Florence Irving Medical Center? They are also doing researches in hearing loss gene therapy.

 

A Study of the Gene Therapy CGF166 in Patients with Severe-to-Profound Hearing Loss
A three-part, multicenter, open label, single dose study of the gene therapy CGF166 in patients with severe-to-profound hearing loss. CGF166 is recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA. The purpose of the study is to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through intra-labyrinthine infusion to improve hearing and vestibular function.

This clinical trial is open to enrollment.

To inquire about participation, please contact:

Dylan Cawley

Research Coordinator

dec2166@cumc.columbia.edu



Principal Investigator:
Lawrence R. Lustig, MD

http://entcolumbia.org/research/cli...-cgf166-patients-severe-profound-hearing-loss

 

This is not news. This trial has been on-going for years.

 

I think he may have been pointing out that there is development going on for helping those with severe to profound hearing loss. Still I wonder with this CGF166 treatment, is the intent to make significant improvement for severe to profound hearing loss or are they just testing those with that level of hearing loss because there is less to lose?

 

The FDA sets quite strict eligibility criteria for them to follow. Maybe they will allow them to loosen the criteria, but will not know for a few months.

 

With the trial taking place in Australia why the US FDA be involved? I also wonder if that is where they will continue the trials.

I'm crapping my pants with excitement to find out when FX will move onto phase II. SO many companies attempting different ways to come up with the same end result which I actually appreciate, one is bound to get something right.

Again, 10 years ago there was the AM-101 and that was it. So just imagine where we will be at in 5 years!

 

Hopefully cellular repair can make the mickey mouse drug trials go away FOR GOOD. I don't see CGF166 concluding until late 2020.

 

What company made CGF166? So many going on now! The people involved with the FX-322 seem to be overwhelmed with the success of their phase I. Which is a good sign. I think since it's not stem cell related and shows it's 100% safe, they will fast track this thing.

 

What is an example of this cellular repair that you mentioned?

 

Just scroll up and look at the name of this thread. It's what we have been commenting on all this while. They are desperate to peddle us a patentable drug but ear disease is too complex for this so now the market demand cell/gene based therapy to recover lost function. Are you new to this thread?

 

Yeah I’m new to the thread. Guess I didn’t understand the difference between the cellular repair versus the Mickey Mouse drugs you mentioned. Was looking for some quick insight from somebody more educated. Shame on me.

 

Kinda wish I was able to be frozen and brought back to read the end result of these studies and trails

 

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some papers

• http://www.tinnitusjournal.com/arti...ical-cordderived-as-potential-sources-for.pdf

password: ttalk

• http://docdro.id/fqeC1dx

 

A nice summary of where we are today and who some of the major players are.

https://www.cnbc.com/2018/01/02/hea...oughs-attract-big-pharma-venture-capital.html

 

Well, there are currently 2463 studies going on worldwide within the field of gene therapy according to wiley.com

After the recent breakthrough in treating cancer, blindness and Hunters disease using gene therapy, the field is now literally exploding and according to researchers things will begin to accelerate from now on. The big pharmas like Novartis, Sanofi and Pfizer have invested millions the last couple of years, so I personally do believe there will be more and more stories of breakthroughs all over the world, and faster than one might think.

 

What recent breakthrough?

 

For cancer; CT019 or CAR-T are now FDA approved

For blindness; LUXTURNA by Spark Therapeutics (Not FDA approved)

For huntingtons; Sangamo Therapeutics (Not FDA approved)

 

Interesting the blindness one, it's only to treat an inherited type of vision loss though. I have read a few articles on retina repair through activating the progenitor cells much like the inner ear - they were able to recreate retina cells but they were unable to integrate into the existing retina cells.

 

Absolutely very interesting, and an important step in the right direction nevertheless. Things like this creates a buzz and more and more researchers are now looking into gene therapy again. I have a inherited hearing loss, so I am keeping up with this in addition to regeneration of hear cells. In the article that I found the info on blindness, it also stated that they are using this science to develop treatment for hearing loss also. So things are on the roll at least.

 

Just FYI; Luxturna received FDA approval in December 2017.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589467.htm

Great progress is being made.

 

News from Australia...
http://www.heraldsun.com.au/news/vi...s/news-story/366e86ae1e6664e487b7a1f9da7e8a01

 

Looks like it's paywalled.