April 3 Meeting Notes

The purpose of this meeting was two-fold:
1) to hear an informative presentation by Stanley Kim, CEO of WinSanTor, a private Canadian-American drug research company. Mr. Kim spoke first, then led us through a Question and Answer Session re: his company’s ongoing efforts to develop a drug to prevent and reverse peripheral neuropathy.

2) to provide an opportunity for open discussion and socialization among members.

Agenda

1) Welcome to all and acknowledgement of new participants (opportunity to introduce themselves after presentation); (2:00-2:15 – Pat Gualteri) Hello everyone and welcome to our April meeting of the peripheral neuropathy support group. I’m Pat Gualtieri, Executive Leader and moderator for today. I’m happy to see so many faces on this beautiful April weekend. I would like to thank everyone for coming, and particularly our new people. We’re trying to stay on this timeframe so that we have as much time both for our speaker and for us to discuss as possible, remembering that the official end of the meeting is at four o’clock. The agenda is twofold.

First we’re going to hear from an expert speaker, Stanley Kim with WinSanTor and Q&A. Steve will be introducing him in a few minutes. Our second purpose is open discussion beginning with a chance for new attendees to introduce themselves and share a bit about their peripheral neuropathy journey and how they heard about this group. Then your questions or comments you would like to make to the group. There is closed captioning available. Thank you Michael Foxworth for working hard to get this up and running for us. We’re going to follow the Zoom norms that we talked about last month. We will wrap up with announcements of our May speaker and upcoming events sponsored by other PN groups.

2) Introduction of Mr. Kim (2:15-2:20 – Steve Klitzman) Our guest speaker is Stanley Kim, CEO of WinSanTor, a private Canadian-American drug research company. He has been the CEO of WinSanTor for 10 years. WinSanTor (named after its founder’s home cities: Winnipeg, San Diego, and Toronto), is currently in Stage II clinical studies with its lead drug, WST-057, to treat diabetic peripheral neuropathy. Mr. Kim is what he calls a seasoned entrepreneur. He’s the founder of companies in diverse industries including pharmaceutical biotech and software, his first company Soft Max was acquired by Qualcomm, and the second company Emotion was acquired by Apple, and both technologies now can be found on most smartphones.

For more information, see the WinSanTor web site at www.winsantor.com , including

https://winsantor.com/our-mission/ , https://winsantor.com/our-story/ and https://winsantor.com/peripheral-neuropathy-online-resources/ and investing https://wefunder.com/winsantorinc/ask

Presentation

3) Presentation by Mr. Kim, followed by discussion and Q & A (2:20-3:00 – Mr. Kim) . WinSanTor drugs appear to be regenerating the nerve cells damaged by the various negative impacts commonly associated with peripheral neuropathy, including diabetes and chemotherapy. The company will begin trials regarding other PN causations in the next few months (chemo-induced and HIV- induced). They are doing research currently on Stage II clinical studies on new drugs to regenerate some nerve cells of people with PN from type two diabetes and chemotherapy. Their earlier animal studies were successful, and they hope to move into stage III clinical testing of humans by the end of this year. WinSanTor’s mission is simple-develop a drug that works. They recognize that there are no treatments for this disease today. Thus, WinSanTor is striving to impact the lives of today’s patients heavily burdened by peripheral neuropathy. They are exploiting every strategy, mechanism, and regulation to accelerate approval of their drugs, including recycling a previously approved safe drug.

Phase 1 is complete and they are now starting phase 2. Their goal is to get drug approval in the US by 2024 and perhaps sooner elsewhere. By focusing on patient impact rather than the bottom line, they’re creating a new sustainable model for pharma companies based on patient need, not just money. WinSanTor is developing a proprietary first-in-class therapy to prevent and reverse nerve damage. Their team has identified a novel biological phenomenon termed “neuronal cholinergic constraint” that inhibits neuronal growth, and is developing compounds that overcome this constraint by promoting nerve recovery after toxic or metabolic injury.

Their lead/first compound, WST-057, is a well-characterized, previously approved drug with an established safety history that has been used for many years against an unrelated indication. This allows WinSanTor a direct path to market, reducing development, time, and cost with a drug that is patented as a new formulation with novel indications. WST-057 is just one compound they are investigating in a family of promising compounds that they have exclusive worldwide rights to. They are strategically expanding WST-057’s indications to all neuropathies, such as chemo-induced peripheral neuropathy (CIPN) and HIV-related peripheral neuropathy (HIV-PN). Although several compounds (all of which WinSanTor retains the rights for) were identified as potential candidates, WST-057 was chosen for its significant safety profile in millions of people over several decades as an oral drug for peptic ulcers. WST-057 was previously approved in several countries in Europe, Asia and the Middle East. It was not submitted to the FDA for approval and thus, in the United States, it is deemed a new chemical entity (NCE) in any formulation. WST-057 is therefore a proprietary topical reformulation of an existing (off-patent) oral drug repurposed to be more conducive to treating patients with peripheral neuropathy. Preclinical findings of a recent study indicate that antimuscarinic drugs such as pirenzepine may be used to prevent or reverse symptoms of peripheral neuropathy. Antimuscarinic medications are often used for several other conditions, including peptic ulcers and incontinence.

Mr. Kim got interested in peripheral neuropathy as an issue to work on when he was asked because of his extensive business background with life sciences and company formation to form the WinSanTor company by the three scientist founders who had created the animal and the cell models for diabetic peripheral neuropathy. They identified some drugs that seem to reverse peripheral neuropathy, diabetic retinopathy specifically and received funding from the US government and the Canadian government. They asked Mr. Kim to start a company with them to advance this discovery into therapies which became WinSanTor of which he is CEO. The name came from the locations of the three scientific founders (Winnipeg, San Diego, Toronto) and he is the business side founder. When he tried to identify more money for the company he discovered very little interest in the investment community and the pharmaceutical industry in diabetic peripheral neuropathy so they remained dependent on the governments to survive. They will be asking for supportive letters to the FDA for approval in about 6 months.

He then provided a detailed explanation of their research and methodology which can be found in the transcript last below but bottomline is that they are seeking to reverse the damage to the nerve endings by encouraging them to regrow using a topical that encourages regrowth. If a person is interested in applying for the study at Eastern Virginia, you go to https://clinicaltrials.gov/ct2/show/NCT04786340?cond=peripheral+neuropathy&cntry=US&state=US%3AVA&draw=2&rank=5. (Recruiting for A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy from Diabetes Mellitus, Drug: Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution, Eastern Virginia Medical School, Norfolk, Virginia, United States)

4) Acknowledgement of donations and report of treasurer on current funding status; (3:00-3:05 – Rebecca) Unfortunately someone sent me a check for the group which was stolen enroute. I don’t know where he posted it from but I never received it, it was stolen. The cheque was altered by almost $1,000, and the bank cashed it. So please people if you send me a check, take it to the post office and send it from there. Do not put it in your own personal, private mailbox because people are having things stolen out of their mailbox and altered and this is not the first time I’ve heard of this happening. There is still the same amount , $1451 , in the account.

5) Announcement of next “Happy Hour” (3:05-3:15 – Terry Orlando and Dave Matz.) we’re gonna have our next happy hour on April 15 at seven o’clock. That’s the time where we can all forget about our peripheral neuropathy and come and talk about other things and hang out with each other, just socialize. We had a great time last time, de Pape played piano for us and Pat had some trivia, so it was a good time for all. Bruce promised to tell a joke at the next happy hour.

6) Introduction of new participants and open discussion of issues and questions of interest (3:15-3:55 – Pat) If you go on our website, we have a resource directory, and it includes providers, medications and supplements, and also products. If you would like to recommend anything or anyone you can add it to the resource directory (https://pnsnetwork.org/for-members/member-backroom/ password: apple$auce ). I also want to tell new participants that on the website, we have a monthly newsletter called Footnotes.

Brian Lockwood: I was diagnosed with idiopathic PN three years ago, started out as a nuisance. I have been chasing neurologists since. Now in the last year its gotten more than a nuisance with the standard symptoms through the feet and hands tingling and starting to get some shooting pain. My fourth neurologist is continuing to do tests and studies. Any chance I have to learn is why I am here. I was introduced to your group by Diane Mowitz, who recommended I call in from Houston, TX to hear Stanley talk about his company and drug.

Rich Davis: I really enjoyed this meeting and Stanley, thank you for your information. I’m similar to Brian, my neuropathy started about 40 months ago. It started out with just my front big toe and my right foot starting to feel numb and I just thought well that was just old age since I was 64. Then it progressed up the right foot, and then passed over to the left foot. So I started seeing a neurologist, as soon as it started getting worse. I’ve actually seen three neurologists, in the past three years, and the latest one, I’m seeing now on a regular basis is at Johns Hopkins, Dr Kornbluth, who has been in this field for 40 plus years, and he’s been very good. The bottom line is idiopathic which that’s the worst word what you want to hear right. My symptoms are mostly numbness and occasional pain. I’m taking gabapentin, 1200 to 1500 milligrams per day. One of the things I noticed when I retired about 15 months ago from a desk job was if I sat for more than a couple of hours my feet would started getting numb and progressed the longer I sat. It was the inflammation of just sitting for a long period so I’ve learned if I sit on something very cold like a hydrocollator which I freeze rather than heat , it allows me to sit for longer periods and reduces the swelling and the inflammation. I’m glad to participate in the group.

Mary Widman: this has been very informative. I had experienced neuropathy about five years ago with a lot of pain, difficulty walking, drop foot, mostly on my right side. The main problem is balance and cannot walk very well. I have gone to two neurologists with no answers. I saw this group’s info in a newspaper article in the Washington Post from 2018. My primary doctor confirmed I had PN so I am here. Physical therapy doesn’t seem to do anything. I want to get some ideas on what’s going on. Bruce recommended she use a walker for the balance issues and peripheral neuropathy exercises. Steve noted cases who claimed to get rid of PN by diet, radically reducing blood sugar.

Rhonda Stewart: I had neuropathy from chemo with extreme pain but never numbness. I did have a bone marrow transplant and they are very particular on everything. I asked my doctor about light therapy for neuropathy. He told me I couldn’t get it because of graft versus host disease. My question is would your treatment be ok for transplant sensitive people? I had my chemotherapy in 2019 and bone marrow transplant on March 26 2019. Stanley Kim: Relatively recently then, most patients get their sensation back from chemotherapy within six months. About a third of the population get permanent neuropathy, and it does start off very similar to everyone else with pain, that eventually does degrade to numbness. Our drugs do seem to work on chronic pain.

Peter Corro: can I drink alcohol if I join your test group? Stanley Kim: I don’t think there’s a problem since it’s something that you rub on the skin.

7) Announcements and wrap-up of formal meeting; invitation to continue conversation afterwards (3:55-4:00 – Pat)

Steve: At our next meeting we’re gonna having a repeat visit from Heidi Garvis on May 3rd. She helps people shelter in place so to speak, stay in their homes or cars to downsizing or sort of caring for yourself as you advance in age. She came to us in May of 2019. The village center in Friendship Heights where Steve lives is willing to support a PN group so if he gets at least 10 people interested he will start and and I’ll keep you posted. Pat said wonderful news because as we’re trying to develop more of a network where people can reach out and in their own communities help develop support groups like this, and increase the opportunity to interact and help each other.

Bruce Malkiin: Offered to send Brian info on a good group in Houston run by Katherine Stenzel that he joined. Brian confirmed he is already a member and it is a great group.

Stanley Kim: Reiterated that he is not a doctor and none of his comments are for marketing purposes to sell you on the drug. Hopefully it was informational and he really appreciates everything that you guys have done. We hope we can help you pretty soon.

Pat: Whenever you’re ready for us to send letters to the FDA, please let us know and we’ll do so, thank you very much.

Attendees (hidden):

Chat Excerpt from 3 Apr 21 Meeting

14:03:23 From Stanley Kim to Everyone : skim@winsantor.com

14:04:19 From Terri to Everyone : Thanks for your email. Thanks for working to help everyone with PN.

14:17:44 From Ms Rhonda to Everyone : I had a bone marrow transplant. Can transplant patients take these drugs?

14:21:31 From Helaine Zonderman to Everyone : Does it work if the myelin sheathing is gone?

14:24:11 From Bill Porter to Everyone : Oxybutynin(drug)

14:26:25 From Terri to Everyone : Are you going to go public so I can purchase shares?

14:29:06 From Mike & Lindy Foxworth to Everyone : Presumably a topical treatment will only work on sensory nerve. but many neurons, such as motor neurons that drive our muscles and allow us to balance, will not be touched by a topical. Would this drug help such neuron?. Might there be a form that could help such neurons?

14:29:12 From Steve Klitzman to Everyone : If the drug already exists for another indication and is perhaps generic why should a physician precribe your brand name drug instead of the chemical under its pre-existing name?

14:31:04 From Mary Jo Edwards to Everyone : What about hereditary peripheral neuropathy?

14:31:46 From Bill Porter to Everyone : When do you think that Pirenzepine(PZ) will be available?

14:35:54 From Mike & Lindy Foxworth to Everyone : Please promise to charge a bunch of money and get big pharma to jump in.

14:36:28 From Terri to Everyone : We will do it. Just tell us when.

14:36:35 From Kathy to Everyone : What side effects have been detected in your phase trials?

14:46:43 From Peter Corro to Everyone : I presume you ask patients to stop drinking Alcohol?

14:46:54 From Rorey to Everyone : Have you done studies on people with autoimmune neuropathy like CIDP?

14:53:49 From Kathy to Everyone : Will this drug be a cure or a maintenance drug?

14:56:18 From Judson Vaughn to Everyone : Tanya, can you use the chat for your question?

14:56:58 From Mike & Lindy Foxworth to Everyone : You use biopsies. Does it grow only terminals (nerve endings) or does it grow other parts of the neuron (such as the axon or cell body)?

14:58:49 From Mike & Lindy Foxworth to Everyone : Have you approached DOD? They were just given some money to study PN

15:00:41 From Terri to Everyone : Ask for expanded access use this summer.

15:01:20 From Terri to Everyone : I am retiring. I can work for you.

15:04:12 From Mike & Lindy Foxworth to Everyone : winsantor.com

15:12:48 From Stanley Kim to Everyone : Yes, we know about the DOD grant funding – but the PN is one of 100 diseases under that grant. We thank you for pushing forward awareness of PN. And, yes, we are applying.

15:14:27 From Judson Vaughn to Pat Gualtieri(Direct Message) : Is Brian on our list?

15:16:15 From Stanley Kim to Everyone : Mike and Lindy – thank you. We know we will do well if we do good for patients.

15:18:57 From Rorey to Everyone : Stanley mentioned oxybutynin. What is the issue with it? I am prescribed it due to autonomic effects from CIDP.

15:23:32 From Terri to Everyone : Come to happy hour.

15:23:47 From Judson Vaughn to Pat Gualtieri(Direct Message) : dcpnsupport.org

15:24:22 From Pat Gualtieri to Judson Vaughn(Direct Message) : please add to everyone and ad for On Your Feet

15:25:35 From Rich Davis to Everyone : I’m a first-timer. What’s the address for Happy Hour?

15:26:00 From Judson Vaughn to Everyone : Mary, my doctor prescribed Metanx (https://www.metanx.com) for diabetes-caused Neuropathy. It is a food supplement and has almost arrested my Neuropathy.

15:26:45 From Terri to Everyone : We will send you an email from Tech with the invite. It is April 15th at 7:00 pm EST.

15:26:45 From Pat Gualtieri to Everyone : Happy Hour is virtual Zoom still – You will get an invitation if you “ join” on our website – https://dcpnsupport.org

15:27:25 From Mike & Lindy Foxworth to Everyone : Rich, everyone on the mailing list will be sent an invite to the Happy Hour Zoom

15:27:41 From Rich Davis to Everyone : Thx everyone for the info on HH

15:28:18 From Judson Vaughn to Everyone : Facebook group for discussion: On Your Feet

15:42:11 From Judson Vaughn to Everyone : calcutt

15:44:41 From Mary Widman to Judson Vaughn(Direct Message) : Thanks for this information. Mary

15:57:10 From Judson Vaughn to Pat Gualtieri(Direct Message) : /donate

15:57:24 From Judson Vaughn to Pat Gualtieri(Direct Message) : dcpnsupport.org/donate

15:58:33 From Judson Vaughn to Pat Gualtieri(Direct Message) : FPN – Barbara Montgomery – April 22 at 3pm Eastern

15:58:56 From Judson Vaughn to Pat Gualtieri(Direct Message) : Heidi Garvis

16:00:58 From Judson Vaughn to Everyone : Village Center in Friendship Heights Is willing to support a PN local chapter. Need 5-10 participants to start a group.

16:01:26 From Judson Vaughn to Everyone : Brian, there is a Houston group

16:03:08 From Kathy to Everyone : Pat, can you please email links to register for the Nutrition & PN broadcast?

16:06:32 From Pat Gualtieri to Everyone : https://www.foundationforperipheralneuropathy.org Foundation website allows registration for their programs, including the Nutrition one on April 22, 2021 at 3:00ET

16:07:06 From Judson Vaughn to Pat Gualtieri(Direct Message) : Great job.

16:07:33 From Steve Klitzman to Everyone : https://wefunder.com/winsantorinc/ask

16:14:39 From Diane Mowitz to Everyone : Thank you, DC leaders, for arranging this wonderful session today and for having this great speaker

Details on research findings and methodology from transcript:

Researchers note that the study results demonstrated the effectiveness of these medications in various aspects of peripheral neuropathy. Peripheral neuropathy is a common condition that is caused by damage to one’s peripheral nervous system. They have identified a novel endogenous pathway in adult neurons that regulates nerve fiber growth. Since normally this pathway suppresses [the] growth of nerve fibers, by use of antagonist drugs against a key receptor in the pathway, they were able to release the fibers from this constraint and permit higher levels of growth. This allowed them to use specific drugs to drive nerve fiber regeneration and repair in disease states such as diabetes and chemotherapy where there is irreversible nerve damage. More specifically, researchers used antimuscarinics including pirenzepine to induce nerve fiber regeneration and repair in cell and rodent models of neuropathy associated with type 1 and type 2 diabetes, chemotherapy, and HIV. Since a variety of antimuscarinic drugs are approved for clinical use against other conditions, prompt translation of this therapeutic approach to clinical trials is feasible. Although this research is preclinical, phase 1 trials will begin this spring. Funding is in place to support 3 small proof of concept phase 2 clinical trials using a topical formulation of the drug to treat diabetic sensory neuropathy. These trials are expected to start later this year. Neurosciences researchers have found that blocking the muscarinic acetylcholine type 1 receptor (M1R) in neurons promotes neurite outgrowth, which prevents or reverses peripheral neuropathy in cell and rodent models of type I and II diabetes, chemotherapy-induced neuropathy, and HIV. They are determining the mechanism by which antimuscarinic compounds like pirenzepine, VU0255035, or muscarinic toxin 7 enhance neurite outgrowth and to translate findings into a therapeutic approach that could prevent or reverse peripheral neuropathy in a range of in vitro and in vivo models. The safety profile of anti-muscarinic drugs is well-characterized, with more than 20 years of clinical application for a variety of indications in Europe. The novel therapeutic application of anti-muscarinic antagonists suggested by our studies could potentially translate relatively rapidly to clinical use.

I’m sure you all know diabetic retinopathy, so if you actually look at diabetic peripheral neuropathy, it’s so prevalent, as you probably all know is that nerve endings die, the peripheral nerves die. And so there’s two parts of the nerves. You have what’s called the central nerve, and then you actually have the performers and the nerve peripheral nerves and the nerves that go from the spine to the hands and feet, and so it looks like a big wire. And so you’ll have two parts of the nerve itself and so you’ll have you’ll have the nerve, which is actually the wiring itself, and then you’ll have the myelin sheath the schwann cells, which insulates the nerve. So that actually can go and the inflammation will travel from this point to this point, there’s actually two parts of a nerve itself, or two, they’re actually two different cells, And that’s actually a tip. That’s what makes a nerve. So this will go from connected to the spine all the way out, until it gets to the hands of the individuals. And so when you have peripheral neuropathy, the diabetes causes damage to the nerve endings. Chemo or HIV or COVID or alcohol can actually also damage them as well as a number of other causes that cause damage. So, there’s two areas we’re gonna have damages so which is the the sensory portion of this, this is the part that connects to the actual the fingers, so you can actually feel. So this is what senses sensation and causes sensation, and then you actually have what’s called autonomic nerve and this is a different cell itself it’s called a Schwann cell. And so when you have autonomic nerve damage, what’s happening is this gets eaten away, it causes a short. This is when you’ll see people who have dropped without other complications. What we discovered is that you probably don’t know this portion of the nerve itself that the axon terminals, it’s called the axon terminals and so you’ll have this go to this scan itself, and it will branch out into a million, a billion different nerve endings, and it grows two millimeters per day. So grows pretty fast. Normally, winds up happening is in this case with people with diabetes, those nerve endings die off. And this is also true, other things, whether it’s whether it’s chemo, so can’t imagine chemotherapy causes damage. And so this dies off slowly. So what the scientists discovered is that, because this grows so fast, especially this portion of nerve endings grows the fastest and use the most amount of energy, so you can imagine that if it grows two millimeters per day it requires quite a bit of energy. And so our scientists discovered that there’s something called mitochondria which actually is the energy source for the cells themselves. It normally would provide quite a bit of energy for this growth, they’re shut off, for whatever reason, and this class of drugs that they discovered, turns it back on. That’s all it does, it just turns it back on, and when they discovered that it turns on the growth mechanism of these nerves, they realize that it’s not really based on diabetes but is actually based on nerve growth, and so they tried it on other forms of neuropathy, not just diabetic, but also chemo, HIV, and a few other different forms of neuropathy Charcot Marie which, which is a rare orphan it’s called Rare Disease or predatory disease, and a few others. And again it’s based on nerve growth itself. And so this is all in animals and so again we’ve received quite a bit of money from the different governments to kind of explore the science and see where it can be applied. And we try this on rats, and in mice and it worked very well and rats and mice but that’s not what we’re trying to solve, which I saw obviously, this problem for humans. And we tested this class of drugs, so there’s literature out there that shows that our group tested this one drug, oxybutynin which hits this target. This construct is called the Mustermann is the colon nergic pathway. And so if you hit that pathway, it actually cascades and causes this energy grow. And so if I get a little too technical, I apologize, but that’s about as much science I’ll try go into, but this class of drugs been around for a very long time, and so we could have actually gone ahead and developed a brand new drug, but there were already drugs, they’ve been around for about 50 years . So one of those drugs is drug called oxy beetroot and oxy B gin was used for use for urinary contents. You can go out there and buy it now, it’s a drug called joemeek. I think they currently sell as it as a gel at 10%. Now oxy v2 has other complications, it gets into the brain, and it’s usually used for short period time, but not for a long period of time. And so it does when it gets in the brain, it causes other problems, it causes memory problems causes dementia, and a bunch of other other problems as well too, but we didn’t know whether this class of drugs were working in humans, we tried this, all this drug in animals, we never had tried this in humans. So we tried this about three years ago, oxygen, It was actually out of a group called evenness, Arthur Vinick based out of East Virginia Medical School, just to see if this drug works, this class works and it works very very well, so it was only 46 patients. We tested this on 23 It was blind double blinded which means that neither the doctors and other patients know whether the drug works or it doesn’t work. So of the 23 of the 46 patients 23 were controlled to see though. And we actually saw no activity with it, so nothing statistical and that means that it has to have significant change where there’s a statistical change in the four things we looked at were nerve growth.Functional sensory problems, quality of life. And then, chronic pain, and actually chronic pain we actuall y did the original test what we thought would just be the three nerve growth function and quality of life, and all three of those endpoints did really well in our study, I mean like, and when I say very well, it was very, very good. And we use statistics, and anything below point 05 is considered very good, and ours is point 001, which means that, so So, if it’s a five, is if it’s point 05 It’s a 5% has to be has to be an error chain, or something that could be due to error at 5%. We’re at point 001 2.003 which means that it was 99.7%, likely due to the drug itself. And so gave us quite a bit of confidence that this drugs, passive drugs we work on nerve growth. Again, we did this through biopsies. We function sensory problems and we test, see what the you had sensory problems, quality of life, walking, you know, active daily living. And then, what surprised us the most, it actually did really well on chronic pain, and this is really surprising because, and so this study was five months, a topic applied every day. And initially some of the patients that complained about increased pain, and that was really surprising for us, because we thought well if it increases pain that may not be a good thing. But surprisingly, over the five months. What thing. So you imagine, if you’re numb. Pain is a sensation. And so if you’re increasing sensation. Well then, pain is, is a component that may come back in some of the patients, and that’s actually what we saw. Eventually it subsided, and I would say that on chronic pain, it subsided. But 80%, and this drug worked on, I would say a majority of patients, I think about 75 3% of patients, so it’s very very positive, very very promising, but we knew going on that that probably was not the best drug. So we chose this other drug and and many of you guys know our other we codenamed ws T oh five seven and WC oh five seven is a bottle here. It’s a off go grab it before, before I before, and it’s, it looks like alcohol, like you know the the sanitizer alcohol. And so we took that drug that was originally used for stomach ulcers. It was a pill, and then we, we, we made it into topical and the topical is, like I said it’s almost like sanitizer, we apply it every day, that drug now is in phase two. And so, so we chose that drug because of the safety probe up over the last, it was approved in 1984 in Germany, Japan, Austria, as a pill, and I know I’m sure a lot of you have been gone online or read about, people buying this stuff. Well, if you take the pill, we found that it actually doesn’t get from your stomach into the skin because it has the nerve endings are, this is where you want to effect the most. And so the topical is probably the most ideal drug for for this for this specific word the most ideal administrator. So that drug is now being tested in Canada, in diabetic retinopathy, so we started in 2019. We were hoping to finish by 2020 and what didn’t happen was COVID. So COVID obviously, as you can imagine, hits people that with cardiovascular and diabetes. Diabetic drugs or diabetic patients. And so, pretty much all of 2020, all of our patients that we were supposed to finish with. They went away, so all the hospitals closed down, actually, Toronto closed down again for the third time. Three days ago, Wednesday. So, as you can imagine what we’re hoping to get results from by the end of last year, we may hopefully get by the end of this year, but knowing that COVID was going to be really bad. And we’re going to hit over and over and over again, what we decided to do is expand those trials into other countries, in other areas and other indication. So now we actually have a trial, I’m not actually not that far me East Virginia Medical School again, and we’re recruiting about 60 patients so if you have diabetic retinopathy, and you want to see to be part of our trials, please reach out to the individuals over at East Virginia Medical School, because they’re recruiting right now.

[Unknown Speaker]

Let me interrupt for a second. There are a couple of questions in the chat room. One is ms Rhonda had a bone marrow transplant. I was wondering whether she could still take these drugs after a bone marrow transplant. And the other question was is it work if the myelin sheath thing is gone.

Stanley Kim: Again we chose this drug because of its safety profile. It’s if you actually look at the nerve endings. I said, again, this nerve endings, the receptors, what attaches to the where, where the drug attaches actually is at the end point right here. It doesn’t affect here as much. This is actually the reason why it doesn’t get from the stomach when you eat a pill doesn’t get to this, imagine over all the way over here, this has to go through the blood, the liver or the kidney and everything else and then get you the the skin itself. So, so the lotion cell is probably the most localized and most targeted all the drugs, the mechanism modes of administration. So, if you’ve had a bone marrow transplant. Again, this is more central right it has to go through the blood, our drug pretty much stays on the skin. So, we don’t think it actually get into the bone marrow nor very, at least not very much. So very, what we did what we discovered was that very little gets into blood, which is actually a good thing for most patients. If you have neuropathy in your internal organs. Well that’s a bad thing, because our drug works mostly at a very local topical area. Again, that’s why we chose this as our first drop. Knowing well for two reasons one is knowing that there’s no other treatment out there. This drug is 40 years old, and got a great safety profile and then likely stays on skin, the best. And just, it’s probably about as what we think is as safe as can be. And again, this is why we chose this drug, as our first one.

Pat: We can, we can assume from your response for Miss Rhonda, that it would be okay for her with a bone marrow transplant because it’s a topical.

Stanley Kim: So what I can say is that I’m not a doctor, and I’m not miss Rogers doctor. And so for me I can’t say one way or the other. What, whether it would work for her, or doesn’t work for her, but I can say that it stays very local. And so it doesn’t get very, it doesn’t get into the blood as much. So, and Dave the second question about shaping. This is the part that I was talking about. So if you actually look at the nerve number, this, the metal part itself and it goes all the way through that is one nerve that’s actual nerve itself myelin sheath is actually made by something called the schwann cell and the schwann cell is, is what causes installations if you actually look at it, a nerve is exactly like this. There is the cell body, there is and then there’s the axon which is this part, and then there’s axon terminals. Over here, a secondary cell, which is called the schwann cell, and I apologize. This is too technical or too scientific cause creates the myelin sheath. And so when you have MS, what’s happening is your body’s attacking this portion of it. So every organ, or every cell is driven by ATP, and that’s the energy sources like it’s what it’s fertilizer for the body or energy for the body and its causes, created by the mitochondria. We don’t know if our drugs, and what we do is we actually reactivate the mitochondria, we increase energy levels for the body. This portion we don’t have to work yet. And the main reason. Again, this is driven by ATP as much as this is, but this grows to millimeters per day, whereas this may grow. You know one millimeter over 15 years or 20 years. So very, very slow and the question then is, does this get repaired as this does. Well we know you imagine if we, this is the weedy part of it, right, this grows the fat or the rich part of it. This grows the fastest so if you add more fertilizer, well this is going to grow like crazy. this part we don’t know. Will it eventually grow this part. We don’t know. It’s one of the studies that we’d like to do. There are other groups that are trying to use our class of drugs for this, we as a group, we don’t know if it works on this myelin sheath. And unfortunately the myelin sheath sheathing is a search of Ms. Autonomic peripheral neuropathy, and then a number of other forms of neuropathy. So, I mean, it’s actually, if you look at the myelin shooting it’s actually also the brains we have Alzheimer’s and Parkinson’s, these other damages. That’s what’s caused, that’s the damage that’s causing there and we don’t know if it works in there as well too. So, are you going to go public, so I can purchase shares will say that to the very end, the last question. So anyway, this, we’re in phase two now and diabetic retinopathy, in Canada in the US, we’re about to start trials in Japan, in diabetic, and then later this year Walsh’s are two trials in cancer chemo this peripheral neuropathy, as well as for HIV supergravity. And so for chemo this property. There are about a third of the patients that get permanent neuropathy, but for most of the chemotherapies, a lot of chemotherapies about most of the patients who will get me. You imagine when you use chemotherapy, it’s a toxic, it’s a poison. So it’s killing those nerves, it’s this question of balance man like he’s gonna kill faster than squat so, so we’re trying that as well, too so. So those are the those are the trials that were were ongoing in the last, this coming here. We’ll try it for a couple other indications, something that was safe to all see till we announce it. But the three indications, again, diabetic North America throughout North America, Canada and US, and also in Japan. In Japan as well to chemo does prefer novelty in the US, as well as Japan, and that HIV news book novelty later this year, based here in San Diego. So those are the three indications that we’re trying. And so I know a lot of you have other forms of PN, for example idiopathic, we as a group will never be unfortunately idiopathic neuropathy means that it’s an unknown cause. And that’s kind of what it is, it just unknown cause. And the problem for us as a company, we need to make sure our trials work well if we if we, if we test on patients who have very varying symptoms of unknown cause it makes our study very vulnerable. We need to control our study as much as possible. And so we’re keeping it amongst the diabetics and chemo and HIV because those patients actually have fairly consistent symptoms have consistent cause, and it’s a much more controlled population, so I apologize that we won’t be able to start a trial idiopathic neuropathy because there’s too many unknowns. Having said that, later this year, hopefully later this year, depending on on our resources. We’re a small company, this has been interesting for us. We have seven employees, and three of those, only came on in the last six months. So for last eight years. It’s been pretty much four of us that have driven the company. And part of the reason is because we’re doing as a pharmaceutical we’re doing everything wrong as a prime minister company, we’re taking on a new science. Imagine your investors, and in big pharmaceutical world right diabetic peripheral neuropathy as a whole is not a hot area. It’s actually, there’s no one else working in purple nobody other than us, which is why the government gave us money, right. So, if you’re, if you’re an investor or Big Pharma, you’re, you’re trying to make as much money as possible, and you only work in areas where it’s hot, cancer COVID You know, those are the two hot areas all timers, maybe a promoter oddity, as big as a problem as it is, it’s unfortunately not a hot area today. So we’re working in, you know, we’ve had very limited resources, very little money. Very few people working in a space that really no one cares about taking creating brand new science, Again, your investor you don’t want to risk, so you don’t want something that’s brand new, as much as you can get, we’re taking an old drug and recycling it, which means is probably less money, drugs are very expensive, and people want to charge as much money as possible. We have said that we’re gonna try and make our drugs affordable, we’re taking an old drug and recycling it. So, all these factors like I can keep going on and on and on. We’re doing everything wrong important to the pharmaceutical industry, as well as investigators, we’re doing this and actually the reason I’m here talking to you guys is because at the end of the day, we as a company because we have no investors, we have no outside professional investors. We’re doing this because of you. And so, I mean, and that means that we have no desire to sell the company. We’re gonna make sure we’re gonna try to make sure that this drug works. And we’ll take on investors who who are in alignment with that, and that means that we’ve not taking too much money, unfortunately that’s investors are another priority, it’s our patients, that is our priority. Investors going to hear that so we’re moving on, we’re getting we’re getting somewhere, so we just, we just signed a license agreement with a big Japanese company so that’s funding that’s gonna find us for at least for the next year so we’ll be fine as far as finding, and we’ll see where this goes. And I think I’ll leave this, now I’ll answer questions, so let me go through this.

Pat: number of questions already in the chat. Begin with several that were in the chat and then we’ll go to the audience. Okay,

[Unknown Speaker] the question of what do you think of was it pure ends up being. What was, when do you think that parenthesis P, P two will be available.

Stanley Kim: So Prinzipien is, is what’s called the active ingredients, whenever you buy Advil, Ibuprofen is the active ingredient so the active ingredient Prinzipien is currently available through Japan, as I was mentioning, Japan, Germany and never brought the country was approved 1984. But it. So yes, but it’s it comes in a pill. It was also tested in children for myopia as eyedrops for myopia, so we know over the last 30 some odd years 40 years. This drug that’s going to be safe, it when it was originally made it was actually made as a pill to for stomach ulcers, so it sits in the stomach, it never really goes outside the stomach. So imagine if you take a pill, you’d have to eat quite a bit of these pills to get to your skin. Right, the WS T oh five seven is that topical local version of Principate that’s targeting the nerve endings. So again, the targets the skin as if you can imagine, this is your nerve. Right. And so targets of this. And so that will be available. We believe, unfortunately, it’ll probably be approved in other countries before it will be in the US and part of the reasons because it’s a brand new drug in the US, it was never predicted. There’s a group in Germany in Japan, it will likely be proved in those countries 2023 24 We hope, knock on wood, and that hopefully 2024 in the US. So, and and but we’re trying everything we can to get this approved. This is actually why we’re also doing outreach, the drug is a brand new drug, there has been never a drug that grows nerves back. And so the FDA is requiring us to jump through additional hoops. This is a brand new drug in the US. So at some point, I would love your assistance, all of you to reach out to the FDA and say look this drug we need today. As you, as many of you know, I mean the, the, there’s the grant mechanism itself. CBM RP, I think all of you guys signed up to, to, to have performed Robbie listed as a potential grant, you know, grant writing, you know for money set aside. How long did that take you guys forever, and to partner up with him. This is something that everyone would do so at some point we’re going to want to your systems and reaching out to the FDA and say look, this is a huge unmet need, we need this drug today. Look what we did with COVID over, you know, in one year. We need that kind of support for personality. Otherwise, the FDA the pharmacy industry, They pretty much neglected this whole field.

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