The Quest for a Cure: A Diamyd In the Rough

Welcome to Think Like a Pancreas, the podcast where our goal is to keep you informed, inspired, and a little entertained on all things diabetes. The information contained in this program is based on the experience and opinions of the Integrated Diabetes Services clinical team. Please discuss any changes to your treatment plan with your personal healthcare provider before implementing. Today's program is sponsored by Diamyd Medical, sponsors of the Dianode-3 study.

Very clever!

I'm pleased to be joined by Ginger Vieira. Ginger's joined us at other times. Ginger, tell the folks at home a little bit about yourself.

Oh, I have lived with Type one diabetes for quite a while, since 1999, and I've been writing books and articles and creating videos about diabetes, uh, for many years. But today I'm actually here on behalf of Diamyd Medical.

Okay. I like the 1999, so you, we could redo that prince song, had diabetes since 1999.

You know, sometimes I say 25 years, but that's not true next year. Right? So I'm, I try to always say 1999. So it's gives,

it... so practically writes itself.

It's perfect.

Well, you do more than just, uh, your work with Diamyd. Uh, you have your own podcast.

Yeah.

The diabetes nerd.

Diabetes Nerd YouTube channel. I'm actually launching the Diabetes Nerd Podcast. Next week is gonna be, uh, I call it high quality conversations with very low production. I'm going for the zero editing approach. It's gonna be really laid back conversations with people I adore or admire.

Guaranteed. You're gonna sneeze right in the middle. It's gonna happen.

I did one before this that I. I tell my guests, if you say something that you don't mean that's on you, you're gonna have to deal with it.

You're gonna try your best to hold that sneeze in and it's just gonna explode all over.

Just be real. You sneeze on the podcast and that's just how it's gonna go.

That's fair. When I first met you decades ago, I mean, I was impressed that you were a powerlifter. You could squat a Buick back then, couldn't you?

Squat a Buick? I could squat 265, I could deadlift 300 pounds. That was my best deadlift, and I could bench 190. That was, that was a different lifetime. I forget about it. Honestly, I was about 30 pounds larger, as you recall, and was definitely at the beginning of my own diabetes self-education, experimenting journey.

For sure. Yeah. You've done a lot with social media over the years and done consulting for a lot of companies. How did you latch on with Diamyd?

Diamyd was trying to do study recruitment and they're, they're trying to find the right candidates for their precision medicine, medicine therapy, which we can get into later. But Diamyd is doing something pretty innovative that no one else has done quite, you know, there's a lot of companies out there trying to develop. Functional cures for type one or ways to prevent the full onset of Type one Diamyd is doing is unlike anything any of these other biotechs have done.

You know, between us, we've been living with type one for 65 years.

All right. Wow.

And we've, we've seen our share of Miracle Cures come and go. The most recent one, which has a lot of us, A bit distressed.

Yeah.

Had to do with, with Vertex, you know, they have a, a, a stem

Well, no, wait, I wanna correct that. It's not that the cells aren't working. Because VX eight 80 Vertex's clinical trial that uses immunosuppression, the cells are working there, but they're using immunosuppression drugs, which are not an ideal trade off for you and me in VX 2 64, the one that they snuck into a recent press release to say, um, wasn't working. That one.

Tomato, tomato, you know?

No, no, it's not the cells. We have hope. I feel like.

We've had the ability to transplant beta cells for a long time, but you have to suppress the immune system, which leads to a lot of other health problems and complications. So we're no further along than we were. So the encapsulation part needs to improve.

Absolutely the true protection part, and I mean their VX eight 80 trial has like 11 out of 12 patients that are no longer taking insulin. I'm really hoping that they would partner with another company that has a therapy. There's one company in particular, SAB Bio that I've learned a lot about. I would love it if SAB and Vertex would partner so that sabs therapy can work to protect vertex's cells 'cause we know the cells produce insulin successfully.

I've got my own way of viewing a cure for type one diabetes when I

I would say the same. It's that it takes care of itself. I would be okay with having something surgically implanted or showing up once a year to get an injection or even three times a year to get an injection right, of something that when I leave that clinic, I am not checking my blood sugar every day. I'm not taking micro doses of insulin.

Yeah, I think about two areas. We have mechanical cures, artificial devices that can regulate glucose. Yeah, we're making progress with the current A ID technologies, but we still got a ways to go with those. We still have to do a lot of the thinking for those systems.

Yeah.

And then we have the biological type cures, which involves. ilet cell transplantation, uh, selective immunosuppression. Even these concepts of smart insulin that activate only as they're needed.

Which it still seem like a fantasy smart insulin. Nobody's really done that. They've been talking about that for 20 years.

Conceptual.

Yeah. Yeah.

So where does Diamyd fit in that spectrum of, of cures?

Okay, so Diamyd's therapy is about precision medicine,

That was my next question.

Yeah. Yeah. So it's clearly a, a relatively common gene and they have already been conducting clinical trials in Europe. They're now at phase three of this current clinical trial. Diagnode-3 is the name of the clinical trial, so phase three for anybody who doesn't know, that means that they know their therapy is, uh, highly effective and safe, right? They've passed the phase one and phase two of a clinical trial.

So right now it's, it applies to recently diagnosed type ones, or at least diag. People who are at the point where they, their glucose is elevated, they require insulin to manage it.

There's a specific timeframe they want, they're for the trial. They're looking for people who are diagnosed within the last six months.

Right. So it's been, and they, so people diagnosed recently and have to start insulin treatment, but also have to have this specific gene sequence that would make the medication applicable to them. That's when I've learned about other research like this with other companies. Is that if they figure out a way for this to work in this population, it can often be adapted to other populations and it can be applied earlier in the course of development of type one.

Yes. So,

And most, most people don't realize that type one diabetes doesn't start when glucose levels go up.

Yeah. Let's explain that, Gary, because a lot of people don't know there's different stages of diabetes. Yeah. Let's, let's dig into that.

Yeah. I mean, stage one is the presence of antibodies. And there are four, maybe five different antibodies that are precursors to, you know, the development of, of, of insulin requirement. But these antibodies, once they're present, then the chance of the progressing to the next steps is very high. I. And you know, stage two is you've got the antibodies and now your glucose levels are a bit abnormal.

Ideally if, I mean, and, but another thing a lot of people still don't know is that these antibodies can develop years before you ever have symptoms and are officially diagnosed. And they know through Trialnet research that many people have antibodies present before they're even five years old. Even if you weren't diagnosed at, you know, I was diagnosed at 13, that's when my symptoms developed.

Okay, I screened mine as well. Now, for those who are not biochem majors, explain what antibodies are.

Yeah, so antibodies are basically the result of your immune system attacking and destroying some part of your body. So in type one diabetes, they know the specific, like you mentioned, specific antibodies, and they can actually test for them, and it's a simple blood test. Getting it isn't always as simple. You can't really just go to your doctor and ask for it.

Yeah. So antibodies can form in response to different aspects of the insulin production and secretion process. So I said there's four, possibly five different antibodies that we look at, but one of them stands out.

Yes.

It seems to be an antibody that is most closely linked to progression to the next steps. Which antibody is that?

GAD.

Yep. GAD 65, that's the one that seems to be, uh, the most evil of the autoantibodies, if you will. So what, what does Diamyd have to offer to counteract this gads beast?

So let's go back in time a little bit. So, the, the creator, the founder of Diamyd is Anders Mueller, and his daughter was diagnosed, they live in Sweden, diagnosed at 10 years old. So this is a, a Swedish born company. And whenever I hear the conspiracy theories that, oh, they've already got a cure for type one, they're just hiding it right.

It's, it's targeting a specific antibody. It's not causing widespread suppression of the body's immune system.

Right.

It's just really focusing on the one specific one that most likely leads to progression and development or progression of type one diabetes. I guess that's what you meant by precision medicine.

Well, the precision part is also the genetic, the gene factor. So in Diamyd's case, the precision therapy is speaking directly to people with this certain type of gene. They know this medicine works precisely in, right, and there's a lot of cancer treatments that are the same way. They've figured out that people with breast cancer who have a certain gene respond better to some treatments than others.

I think of it kinda like laser treatment for retinopathy now. You know, it used to be if you had hemorrhages in the back of the eye, there wasn't much they could do. Anything they tried to do would destroy areas of the retina that it shouldn't. But now with lasers we can pinpoint those blood vessels that are damaged, seal them up without damaging the tissues around it. In this case, you're able to take a specific, this Diamyd drug.

I would rather you detail that. Gary, I can't, I can't speak to those specifically. I know it doesn't sound good.

It's not, I mean, it, it opens us up to all kinds of infections. It's hard for the body to fight viral and bacterial infections when the immune system is impaired on a large scale. There is a lot of side effects involving like oral health and a lot of other parts, you know, body functions that, yeah, we tend to have issues with, with immune sup, widespread immune suppression. So this targeted therapy, yeah, seems to make a lot more sense

It's critical

Then we've had in the past.

I hear from people whenever I post anything about diabetes cure research, I always hear from people saying, well, why can't we have X, Y, Z? Like VX eight 80, for example, requires immunosuppression, which makes it very undesirable for a significant percentage of the population with type one, right? It's really intended only for people who are struggling to get through their day and function.

That's it. It's a trade off. And for most, the vast majority of people with type one widespread immune suppression is not worth the trade off. Yeah.

Okay. Thank you for explaining that.

And now a word from our sponsor. If you were diagnosed with T 1D in the past six months and are between ages 12 and 29, here's a clinical trial you might want to consider. GAD 65 from Diamyd Medical teaches your immune system to stop attacking your pancreas beta cells. Diamyd is currently recruiting study participants in the US and Europe. Visit diagnode-3.com or email clinicaltrials@diamyd.com to learn and see if you qualify. And now back to our program.

So the first thing is age range. So they're looking for people between the ages of 12 up to 29 years old. And then you've been diagnosed within the last six months. And then the first step after you've reached out through the di, it's di node-three.com. After you've reached out, the next thing they're gonna ask you to do is a blood test to see if you carry this gene. And if you don't carry the gene, you don't qualify to participate.

What's in it for someone who receives the treatment?

So what Diamyd's therapy aims to do is prevent or delay or significantly reduce your need for exogenous insulin. Insulin from a vial, from a pen, right versus endogenous inside your body. So if someone is diagnosed in the last six months, like you said earlier, they're already taking insulin. But Diamyd's therapy hopes to significantly. Change how much insulin they actually are going to need every day and potentially even delay the progression because we don't realize it.

Right. You were a honeymoon girl.

Yeah. Yeah. I was living my best T1D life with a pancreas still helping out. So GADs therapy, sorry. Diamyd's therapy really aims to prolong that honeymoon phase. Um. That's a big one.

That is such an important thing, and any family with type one knows how wonderful the honeymoon phase is. I, I have enough patients I've seen where if the, if someone's producing just even the tiniest bit of their own insulin, it provides this beautiful buffer. Glucoses don't get to extreme highs or lows because the pancreas can make adjustments to keep things from getting too far outta range. So you can almost do no wrong.

Do those families, they don't. So you were saying how much they appreciate the honeymoon phase, but can they appreciate it when they're in it or is it only after looking back?

It's usually afterwards.

Yeah. They don't even know what's coming.

Yeah. Yeah. I try to show them graphs of mine or someone else's glucose bouncing around and they, oh my goodness, this is what I'm headed for. Yeah. I didn't get a honeymoon because when I, when I was diagnosed, I had already gone about three or four months of peeing my brains out, losing weight, all the symptoms. So by the time I was diagnosed. My beta cells were dead on arrival. I had no insulin production left at all, and I see this now with patients.

Yeah. And so another thing to think about, uh, when you're considering a clinical trial is in many clinical trials it's 50/50 of who gets the placebo and who gets the actual therapy. And in Diamyd's trial, there's a 30/70 split. So 30% are getting a placebo, which is basically like, you know, they're giving you a pretend. It's like, might as well inject you with saline instead of the therapy. Right? And then 70% are actually getting GAD 65, the investigational therapy. So that's a big deal.

Yeah. But even if you don't, you're contributing to some very important research, the groundbreaking research.

Absolutely.

You're familiar with, uh, tzealed?

Yes.

Sanofi's Drug Tocilizumab is a generic name. What are some of the differences between Diamyd treatment and something like Tezealed, because they're Tezealed Sanofi's already studying it. In phase three, you know, when somebody's recently diagnosed, so yes. What are some of the differences?

So, well, one of the first biggest differences is how it's administered.

yeah, two week. Two week,

14 days full. 14. You have to show up every day. For 14 days, which means mom and dad are taking off from work, you're missing school, potentially traveling somewhere. Right. You're, you're paying for all that. And I wanna remind me to mention that with Diamyd's in Diamyd's clinical trial, it's three injections, not some big to-do.

squirming in my chair here.

No, no, no. Squirming Gary. No squirming. It is really no different than getting a, a blood draw from a vein in your arm, and they just know that is the, the most effective spot to introduce their therapies.

So three monthly injections.

Yeah. So one, you know, three month process with one injection per month. And here's the cool thing, if you don't live near one of the clinical trial sites, they will pay for your travel to get you there. And their, their trial is there's a whole bunch of cities across the US you can find all those cities listed at diagnode-3.com and then multiple countries in Europe are also recruiting. So they're really trying to make it as easy for the participant to get involved as possible. Yeah.

So once the injections begin, is there additional care that's provided or treatment that's applied?

Yeah. Then there's, um, monitoring and basically looking at blood glucose levels and C-peptide levels to measure.

For anyone listening, C-peptide is an indication of how much insulin you're producing.

I recently had funny story for you. I have a, a new endocrinologist. I don't really. I don't really go to an endocrinologist for like ongoing support. Right. I have Gary Scheiner in my back pocket. If I have a real insulin question, I can call Gary, right? Um, or Jenny, who's on your team? I'm good friends with. My endocrinologist writes prescriptions for me and she, she was like, oh, you only taking this much long-acting insulin. You must still be producing insulin.

Yeah. So when somebody makes their own insulin, when the pancreas puts out insulin, we also get this little molecule called a C-peptide, and they only call it that 'cause it's shaped like a c. It's very scientific. Uh, and when we inject or, or pump insulin, it doesn't have that C-peptide part. So that's how we know how much insulin your body's making as opposed to how much you're taking. Yeah. So the C-peptide is sort of a surrogate measure of how much insulin the body is making on its own.

It's primarily C-peptide and blood, blood sugar levels, and A1C. So there is that follow up period and you're contributing to an incredible, hopeful breakthrough in research that could, I mean, I just imagine like if another really cool thing about. GAD 65. This therapy is that it really has no significant adverse effects. You can't say no side effects of any medication, but its safety profile is considered remarkable by the whole scientific, that's the language I use.

Absolutely. And it applies to adults too, you know, it's not just kids.

Absolutely. No.

Adults who they enjoy the honeymoon and they benefit from that honeymoon equally, as much as kids do. Okay, so you mentioned that if somebody doesn't live near one of the test sites, you said there's 13 across the US and several in Europe as well. Mm-hmm. That Diamyd as a company, will pay for their travel to receive their treatments.

They will. Yeah.

So that would be like once every three, once a month for three months.

So you're committing to traveling to that clinic site three times and then at some point down the road, six months to a year. A follow up appointment.

Okay. Yeah. A lot of the other data, the sensor data, insulin data that can be collected on a virtual remote basis, I imagine.

I believe so.

Okay. All right. Um, well, I mean, that was mainly what I wanted to learn about this. I mean, this is exciting. Uh, it's just a matter of, of getting the word out, I guess, and letting clinicians

Yeah. I mean, can you imagine, I just can't even imagine. I've had a couple families, parents reach out to me on like private messages on Instagram saying, Hey, my child was just diagnosed. Last month, and I see that you do a lot of stuff on research. Is there anything they can enroll in? And I've introduced those families to the DRI, the Diabetes Research Institute, which works closely with Diamyd and many other companies trying to develop cures and treatments for Type 1 DRI can support them.

Yeah. That applies to both pediatric and adult patients. Yeah. 'cause this goes up to age 29. I'm guessing that, you know, once this study is completed, they're gonna start looking at similar outcomes in younger kids and in older adults, and maybe start looking beyond the six month time interval. So it, it'll end up, uh, like I said, they'll be able to extrapolate this to a lot more people eventually, but this is a very important starting point.

Yeah, and they're a very small company. Um, they're really only 30 people. This is not big pharma. This is a really small company that started, um, the heart of it is Anders and his daughter, who's an adult now, but they're determined to find a therapy that that's life changing.

It's how things happen. Necessity is the mother of invention, right? Uh, this is how, you know, islet as a, or the Beta Bionics got started, said Dana's child had diabetes. This is how all the open source, you know, the loop systems and all.

Yeah.

Got started. Parents got tired of waiting for good tech for their kids. So they,

and Vertex, I mean, vertex bought sema. Doug Melton's son was diagnosed at like six months old. So yeah, it, it all starts really at the heart of having known this disease up close.

So, Diamyd, this is exciting stuff. Uh, right now it's, it's a. They're looking for research participants between ages of 12 and 29 who are recently diagnosed and started treatment for type one diabetes. Uh, it involves a, uh, oh, and they also have to have that specific gene, and almost half of the diagnoses have this specific gene that helps ensure that the medication, the Diamyd medication is gonna be effective for them.

And Diamyd will test you for that gene. I've had people say, well, how do I know? And I'm like, well, that's, you call 'em up. Clinical trials@Diamyd.com is their email. You get involved and they will, that's the very first thing they'll do is see if you carry that gene.

Yeah. Our show notes will have all of the contact information people can look for, but. The basic info diagnode-3.com now they can go and learn pretty much everything we covered today, um, at that site, and I strongly encourage people to do so, and healthcare providers encourage your patients to do so as well. So Ginger, thank you so much. Someday I gotta get you to my gym. You gotta teach me how to work. My, my deadlift is lagging.

Oh, that must be it. Uh, yeah.

Yeah, because I, I've known, 'cause even there's a couple people on my team, like Anna, our uh, our social worker, she, she can deadlift more than I can also, and I'm like. What am I missing?

Deadlifting was my favourite favorite, that was my favorite. And the little details and the technique of how you're standing and how you're grabbing the bar and where you put your weight in your feet and what you do with your arms and your shoulders and your lats before you lift that bar a little. Those little details.

Yeah, I got some things to learn from you. That's for sure.

It's about time, Gary.

Yeah. And, uh, I, you just, uh, published second edition of your book on type one Diabetes and Pregnancy.

Yes. We're super excited about that. It's got all new sections, all about AID pumping during pregnancy and yeah was overdue. Jenny and I were both about to give birth to our second children before we published the first edition. We were like, oh my gosh, get this out because we'll never get this book done if we don't get it out before these children are born.

That's right. Yeah. Your kids are about the same age.

Yeah. Yeah, they are.

Alright, well again, thank you Ginger. I encourage people to look for the information about Diagnode-3. Thank you so much. I'm Gary Scheiner. Thank you for listening, and I wanna remind everyone to keep thinking like a pancreas. Thanks for tuning in to Think Like a Pancreas, the podcast. If you enjoyed today's episode, don't forget to like, follow or subscribe on your favorite podcast app. Think like a pancreas.