WinSanTor8 karma2019-05-06 16:08:26 UTC
Wow, lots of questions...I'll do my best.
View HistoryShare Link
WinSanTor7 karma2019-05-06 15:45:12 UTC
Stan: Sorry if I'm taking two steps backwards to move forward. Clinical trials is Phase 1 (safety), Phase 2 (activity and safety) and Phase 3 (safety and efficacy). Typically, this is first in the US and then after approval, into other countries (Yes, long process).
WST is now in Phase 2 for diabetic peripheral neuropathy, starting in Canada, then in Europe and finally US. This is all planned for this year. We will start trials in the US later this year, hopefully.
Yes, WST-057 was approved in other countries in a pill for stomach ulcers, never approved here. Either way, although faster, still has to go through clinical studies.
WinSanTor7 karma2019-05-06 16:00:47 UTC
We are very patient centric - so we are doing everything we can to get an impactful drug to patients ASAP. We are impatient as well. For some patients, they can apply for one of the several trials we'll have ongoing this year. It will start with diabetic peripheral neuropathy. Later, hopefully we will have trials for chemo-induced peripheral neuropathy. We are looking to expand into other forms of neuropathy soon.
A lot of our activity will depend on our resources. We are a small company reliant on, for the most part, government grants. This is a field that is neglected from pharmaceutical companies, and thus investors. I've been told that, even with data that shows reversing the disease (some may call it a "cure" for certain types of PN), that there is no market. That is what we fight.
We also want to learn more about our patients, so please to go our website (www.winsantor.com). We have a survey. I'm learning so much from our patients, so please give us feedback. We hope that we will one day be able to convince this industry (yes, my industry) that wanting to develop cures is the only thing we as an industry should focus on (money will follow).
WinSanTor5 karma2019-05-06 16:10:05 UTC
Stan: Honestly, I don't know. It seemed like a good idea to me and our team. We figured if we were doing this for patients, why not allow them to benefit in more ways than an eventual drug. Plus, we know we will have them on our minds the whole time (some of my shareholders are very ... "opinionated" - LOL - they are all good).
I'm not from the pharmaceutical world. If you read my bio, you'll see that I come from the world of innovation (mostly technology and biology). I saw something in the pharmaceutical world I didn't like (not everyone, but enough) where I figured we weren't going to play that game. We are trying to develop what we percieve to be a sustainable healthy company.
Sorry if I didn't answer your question. I'm not that smart - LOL.
WinSanTor5 karma2019-05-06 16:29:48 UTC
Stan: I've never used AMA either so we are even.
1) Idiopathic is tough for clinical studies or for approval. It is PN with an unknown cause. And with so many different symptoms, it will be hard for us to run trials for idiopathic peripheral neuropathy.
There is hope. Again, we are trying to do everything we can for patients. So, with the new "Right to Try" provisions of the US laws, we may be able to help some patients earlier. One thing patients can do is fill in the survey as we still are learning about peripheral neuropathy generally. I learn so much from patients, including their symptoms. As we see what symptoms are being resolved, we may learn better how nerve regrowth affects these different symptoms.
2) Interestingly, we do see increase in sensation so increase in pain could be an affect we may see in some patients, temporary or otherwise. The data of the scientists have not been published and some of this, we are also validating in the phase 2 studies. But things look promising.
3) I think Katie answered this question.
4) Unfortunately, I cannot tell you what to take, supplements or otherwise.
5) Many animal studies do not translate well. So far (knock on wood), we do see strong correlations between what we saw in the animals and in humans.
Copyright © 2014 BestofAMA.com, All rights reserved.
reddit has not approved or endorsed BestofAMA, reddit design elements are trademarks of reddit inc.