Bro trust me, it doesn't matter who gets it first, just as long as it's proven to work. Just imagine if it's established it helps or cures our condition!
How you doing P? Hope you're OK.
Honestly been a rough time since April and still is. That is the nature of the beast, isn't it. Back to Tinnitus Talk after a break. Really hope we get some good news soon.
No, they will file for Focal Epilepsy first using the Phase 2 plus OLE and the Phase 3 data.
That is exactly the hope, however, I don't agree with you as regards Clinical Trials.
The reason is probably as it was discussed in the OTO-313 thread: seizures per month is probably much easier to measure as an outcome versus tinnitus improvement.
Thanks for the detailed reply. Is this reformulated version being specifically done with the aim of having a tinnitus treatment available at the end of it?
Yep. Thanos has done some amazing research but the lack of any movement towards any trials is frustrating.
As some others on here, I have tried every means known to me to contact Prof. Tzounopoulos and his team, but he will not answer a very specific question, which I feel is in our interests.
I wonder if Xenon Pharmaceuticals knows about the hype of their anti-epileptic drug in the tinnitus world.
What cheers me is the knowledge that the research field is alive and flourishing. When I see all these different approaches:
I wonder, does the DoD even know XEN1101 is a similar drug to RL-81? How "in the know" are these groups? Maybe someone ought to contact the DoD or Prof. Tzounopoulos, or both, with your idea. I dunno if Prof. Tzounopoulos would like the idea, though, since it basically skips over his drug. It'd be awesome, though, to see the collaboration and the clinical trial happen for tinnitus. I would love to see Xenon Pharmaceuticals do compassionate use, too. If a drug exists that can truly help those with no alternatives (people like us), then a company should almost be morally obligated to step in. Wishful thinking perhaps, but helping people should come before money and unnecessary red tape. There are ways to do compassionate use properly without high liabilities. Some people are literally dying here from tinnitus and hyperacusis.
Why are the hopes so high on the XEN1101 for tinnitus? A lot of research is saying tinnitus is mostly due to NMDA and the glutamate being on high, causing overexcitability to the nerves. How do you tackle this? XEN1101 looks like just a small part of the picture...As some others on here, I have tried every means known to me to contact Prof. Tzounopoulos and his team, but he will not answer a very specific question, which I feel is in our interests.
As a world leader in tinnitus research, particularly as regards the reformulation of Trobalt, and the effect of the Kv7.2 channels on tinnitus, what are his thoughts on a drug such as XEN1101 being an effective treatment for tinnitus?
Some feel it is irrelevant what he thinks, but as for me, I really would like his opinion on this.
In fact, the whole logical side of me can see a potential for a collaboration here. A small team full of tinnitus specific researchers allied with a large corporation with $800M in cash, that do not want to focus on tinnitus at present.
It's as easy as this. Department of Defense, Pittsburgh Hearing Research Center and Xenon Pharmaceuticals run a proof of concept trial with XEN1101 as the lead candidate. This could be a small Phase 1 trial with 20-40 participants and be run by Pittsburgh, funded by DoD, with Xenon Pharmaceuticals the commercial partner. It this not just logical?
If results are positive, then a larger Phase 2 could be run, and also we could have off label prescribing until the data from this Phase 2 are in. In the meantime, Pittsburgh could still continue work on RL-81 if needed.
As for clinical trials, Prof. Tzounopoulos is STILL pre clinical. He would need to do 3 trials to get a treatment to market. This takes an average of 9 years, from IND to NDA and commercialisation. He would also need to partner with a larger corporation just like Frequency Therapeutics was a spin off from Langer Labs at MIT.
I don't know what age the Professor is but at a guess he is maybe late 40s and perhaps early 50s. The chances of him bringing a treatment out during his career at this pace are unlikely.
I guess a lot of 'academics' just like research. That is their game.
More research papers are useful, but I don't think any amount of typed words is ever going to reduce our tinnitus.
What we need is action.
Yes but what I said is a fact. Maybe XEN1101 will provide partial relief then...
But, to conclude:
Just adds more evidence that CNS hyperexcitability and deficiencies in the ion channels are a MAJOR cause of tinnitus.
Member
