GA Focus - Stroke UGA

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Episode Transcript

(00:10):
Welcome to Georgia Focus. I'm JohnClark on the Georgia and News Network.
In November of twenty twenty two,I suffered a stroke. It has taken
me this long to get back tonormal. But a lot of people don't
get back to normal. A lotof people have to live with the side
effects for the rest of their lives. A lot don't even make it at
all. The University of Georgia's RegenerativeBioscience Center recognizes this and is doing something

(00:33):
about it. Here today, we'lltalk about what they're doing with Steven Steie.
He's a d W. Brooks Professor, imminent scholar and the director of
the Regenerative Bioscience Center at University ofGeorgia. Well, Steve, strange how
we got together. I had astroke and someone I know, laurd Smith,

(00:55):
actually recommended you and told me,oh, I got the stroke guy
for you, and here he is. And I hadn't mind about it a
little over a year ago. Buttell us about what you're doing here at
the University of Georgia. Thank you. First, thank you for inviting me
to have this conversation with you,John, and so good to see that

(01:18):
you're doing so well. After astroke. I mean, there's eight hundred
thousand people in the US that havea stroke every year, and most people
do not come out on the otherend as well as you have, So
I'm more power to thank you.So yeah, I've been at the University

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of Georgia for twenty five years.I came here as a Georgia Research Alliance
eminent scholar. I'm indebted to theGeorgia Research Alliance and what they've done for
me at the University of Georgia.It's opened many doors and opened opportunities to

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talk to other investigators across the state. One of the people that I have
a very good relationship is David Houseat the Medical College at Georgia, and
he is a well known stroke expertin the field. We do a lot
of research in the area of stemcells, and we've been talking about how

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we might be able to work togetherin the future. And one day my
postdoctoral fellow in my academic lab andI were talking and we said, yeah,
stem cells are great, but whatabout taking what the stem cells produce

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and using that as a therapy.And we started along that road of research
here at the University of Georgia anddeveloped the technology. In my academic lab
here where I'm director of our RegenerativeMedicine group, we have about thirty five

(03:07):
faculty, so we collaborate between theVet School and the Animal Science Department and
cell biology and engineering, and wehave a great group of faculty and graduate
students that are part of it.And from those collaborations, this opportunity came

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where we have one of the beststroke people in the world here at UGA
now and doctor Frank West that's developeda pig model for stroke, and for
any therapeutic it's only as good asit's show. It's only as good as

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how well it does in an applicationsuch as stroke. So we have to
have models that replicate what happens andstroke and people. Mice are a good
model, they're not a great model. So we thought, well, together

(04:12):
with Frank West, we should puttogether a great model for stroke and what
it replicates in humans, and sowe did that together. But really it
was doctor West that took the leadon that. And the pig brain is
much larger than a mouse or arat. It's very similar to the human

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and architecture, so you know,the brain has these grooves and valleys and
things like that. Mice don't.Pigs do have that architecture, and also
it's composed of the same amount ofmaterial we call white matter and gray matter,

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similar to that of humans. It'sa long story but short. In
short, we were able to showthat our therapy worked in both mice and
in pigs and that was an AHAmoment. Yeah, we were able to
get pigs to recover within six daysbefare they had had a stroke, never

(05:18):
seen that before, and they're basicallyback to pre stroke conditions. We have
a video that we show people ofpigs walking down a track with those that
have had a stroke and those thathaven't, and it's remarkable that the pigs

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with a stroke that got our treatment, we're back to the same thing that
had not had a stroke. Andso it's really a remarkable opportunity for us
at the University of Georgia to bringa therapy forward and it really the only
way to do this john and getit into the clinical trials is to work

(06:03):
through industry, and that's important.So one of the things we've done here
at the University of Georgia and wehave on this floor that you are here
today in as a incubator for smallcompanies as well. So at the same
time as developing this technology in myacademic lab, we were able to develop

(06:25):
a company that could take this technologyforward. And that company is called the
Runa Bio and there's numerous investors herein the State of Georgia that have invested
in the company wanting to see atherapy, a new therapy that could be
developed for people with stroke and otherneurological diseases as well. So that's how

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the company has been developed so farand are just last week we announced that
the Food and Drug Administration has clearedour drug to be used in humans.
So we're excited about that. Wereally we're really pumped about the opportunity to

(07:11):
take this technology and use it inpatients that could really benefit from a stroke
treatment today and that will happen,we hope in the next six months that
that will happen. That's get intoclinical trials. So we've got a clinical
site in Texas and Houston, butwe're looking at other sites, one in

(07:38):
the State of Georgia as well,So it could be I mean not yet,
but it could be out and aboutall the place within a certain amount
of time then absolutely, I meanit it happens in phases. So the
Food and Drugs Administration, I mean, the first concern is is it safe?

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So will we have the opportunity toshow that it's safe and potentially effective
in stroke patients right away? Typicallyyou go into patient or people that you
know, normal population people just toshow safety. But the Food and Drug
Administration thinks that it's important that weuse it in stroke patients right away to

(08:26):
show that it's safe there and potentiallyeffective in those those patients. So it's
a small study initially, but ifit's successful, we'll move it on to
the next phase and get a largerpopulation of patients. Would it be the

(08:46):
stroke buster you hear about the strokebuster? I don't know if I had
it. I don't know if Ihad it to day, I don't know
why I was out of it.So would it be that, Would it
take the place of that? Orbe that it's something like that actually a
add on therapy to something like that. So if people are fortunate enough to

(09:07):
come to the hospital within a fourhour period and they have a major blockage
of an artery in the brain,they can get a drug called TPA that
breaks up that clot. As youwere describing that clock busting drug and that

(09:28):
opens the arteries so that there's whatwe call reperfusion or blood flow back into
the brain. Well, at thesame time, there's been a lot of
damage that's been done and there's majorinflammation in the brain. That clockbusting drug

(09:50):
gets new blood flow, but itdoesn't take care of the inflammation. So
our drug does. It reduces inflammationin the brain. So it's an add
on to that potential for those patientsthat are five to ten, maybe fifteen
percent of the population of stroke patientsthat are able to get that drug,

(10:13):
we could give that drug in addition, but there's eighty five percent of the
population of drug patient drug sorry,stroke patients that don't get a drug,
and so we can go into thosepatients as well. So we hope to
be able to help all patients thathave had a stroke. Is it a

(10:35):
case where you know a situation withmine, I actually right away and got
to the hospital right away, butsome people still wait, wait now,
it'll be all right, But I'dbe all right, and that's what causes
the damage. I guess absolutely everyminute counts, Yeah, second counts.
Every time a second person has astroke, they're losing millions of neurons in

(11:00):
their brain. So the sooner youget to the hospital if you think you're
having a stroke, the better.And the major centers have reduced the time
from when a patient gets entered intothe hospital to the time that they get
treatment to less than an hour,so it's a really important Every minute counts

(11:24):
to get that treatment in as quicklyas possible. So we hope to once
they get that initial treatment and diagnosisand get as much as they can initially,
will come in behind that with ourdrug. That's basically what we'll do
is give an IVY dose. Thepatient will also already have a IVY in

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their arm most likely, and heor she will get our drug by just
into that IVY lead and they'll getthat for the next forty eight hours.
So again trying to protect the neuronsthat are there, but also reduce the
amount of inflammation and that inflammation willstop and we'll protect the brain from for

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lat image. So what do youhave to do Now you have the FDA
approval to do certain things? Nowwhat do you what do you have?
What's the end game? When doyou say, hey, look we have
a drug. Yeah, it's it'snot as quickly. Yes, we all
hope, you know, I neverthink things move as quickly as I think

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they should. But this is areally major first step to just get it
into patients, so that will followthese patients for ninety days to even out
to a year. But the FDAsays this is an important area and if
your drug shows initial benefits at ninetydays, we may be able to start

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a next set of trials, maybea different population of patients, and it
myst likely will and we'll go intomore centers around the US to do that
be a much larger study. Soit's a major accomplishment for our group and

(13:31):
for a state to be able tobe the first in the world to have
a therapy like this going into strokepatients. And we're not stopping there.
We're moving into animal studies. We'vegot some initial promising studies in als Lugarrick's
disease that we hope to be ableto start doing some discussion with the Food

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and Drug Administration for that therapy inthe future as well. Wow, that's
that's amazing. You know, assomeone who has been on that end,
I see any any development as amazing. Any development for stroke or ALS for
that matter, because it turns intothat, yes, what about als,
will that do? Talk about whatwe'll do there, Yes, in ALS

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will really do a very similar thingwhere we'll give the patient the treatment.
We think that we could actually givethe treatment through inhalation or through a nasal
application. You know these drugs nowthat you can give as a miss through
the nose, Well, the noseis connected to the brain by the old

(14:48):
factory bulb, and and we thinkwe can give it to ALS patients,
maybe in the future, Alzheimer's Or'spatients as a daily nose spray, so
they give you get a no spray, you give it to yourself, and
you've got that treatment for that day. And that would again be a major

(15:11):
game changer for patients that have thesereally terrible diseases. It's all connected because
in all of these diseases and strokeinjury and traumatic brain injury, there's a
lot of inflation inflammation getting going onin the brain, and so we're really

(15:37):
treating that particular area of deficiency ofdrugs. Today, there really is no
good treatment that really reduces inflammation inthe brain today in patients with all these

(15:58):
diseases. So we're really excited aboutthe breadth of the opportunity for a drug
like this. I didn't realize untilthat happened how complicated the brain is.
I mean, I knew how complicatedit is, but how much more complicated
it is. Well, so itreally is. It's a complicated thing and

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it's inflamed. That's complication. Yes, yes, yes, And you hear
about in Alzheimer's disease, these amyloidplaques and tangles that are into and it's
really complicates things in the brain.But that is that causes inflammation in the

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brain. And yes, we wantto get rid of those plaque, but
at the same time, we needto reduce the things that those plaques do
that are detrimental to the brain.And we can do that. We think
over time what we say chronically inpatients with Alzheimer's disease and ALS. We're

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starting with ALS. ALS is youknow, as you know all of us
know people that have gone through ALS. It's a very devastating disease. There's
no no treatment to speak of.There's been a few new advances in the
field, but no major breakthrough inALS. And for many patients, I

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mean that it comes on very quicklyand affects them very quickly. So it's
something that that is a big need. And as we all know, dementia,
Alzheimer's disease in the future is goingto be a major player in in

(17:55):
our health our healthcare system, thecosts to our healthcare system, and if
we could get a cost effective treatmentfor them that they can take every day
in their homes, that would begreat. That would be fantastic. How
do you you know you look atthis like, let's let's think. Let's

(18:17):
let's take a look stroke. Now, how do you start that? What
do you what do you start?I mean, what do you know?
Do you? Shot? Is aspray? What do you Where do you
start? Then? Where do youstart at? First? Well, it
started quite a while back, Yeah, when we thought, okay, let's
take the stem cells. Because I'vebeen working in neural stem cells for over

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twenty years in research in that area. We initially thought, well, there's
loss of brain cells in stroke andother diseases. Why don't we go in
and try and replace those those nervecells, whether they're neurons or astracytes,

(19:02):
all the things that make up thebrain, and then we could reconstruct the
brain. That was a really nicethought about twenty thirty years ago that we
could do something like that, andwe tried that and it was interesting where
we would go in and you'd haveto drill a hole in the skull and

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have a needle and inject them intothe brain. The animals that we did
that that had had a stroke,yeah, they did better for a while,
but then the stem cells then stickaround, and we were thinking,
wow, why is that And ifthey're having a beneficial effect but they're not

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sticking around, maybe it's something thatthey produce. And that really led us
to think, well, okay,our next set of studies is going to
be taking our rug that comes fromthe stem cells and use that in a
model for a stroke. So ittakes a number of different steps, sometimes

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small steps, sometimes large steps thatget you to that point where you think,
oh, we really have something herethat could be used. And now
because this comes this is a verysmall drug that comes from the stem cells,
you don't have to drill a holein a person's head to deliver it.

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You can give it to an IVinjection, as I was mentioning,
through an IV lead into a patientand all patients that come into the emergency
room that have a stroke have areconnected with an IV so that's it's much
better for them. And we cangive it over time, so when those

(20:57):
stem cells would have disappeared, wecan come back and give what those them
cells produce. In a repeated fashion. What what do you need now?
What can people do to listen tothis show? What can they do to
help you advance this? I knowyou need money. It takes money to

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do. It costs a lot todo a clinical trials. And I mentioned
that we have a company called aRuna Bio that's taking the technology forward.
Uh so we we have investors inthat. We've done a lot with friends
and family, but a number ofpeople from the state of Georgia and elsewhere

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have stepped up and wanted to bepart of something that's coming out of the
University of Georgia, but larger thanthat, something that can help patients that
have a stroke, that have hada LS and and so we're we are
always raising money. The companies areno biomedical or we can definitely talk to

(22:07):
your listeners when they'd like to.They liked it. But also through the
University of Georgia as well, wehave a number of areas where people can
contribute and donate to the University ofGeorgia that can make a difference in that
area as well. So it doestake a lot of money. Yeah,

(22:30):
a clinical trial like we're talking initiallyis in total probably about ten to twenty
million dollars to just do the initialphases. After that, it'll take a
lot more. We hope to bythen be able to partner with a large
pharmaceutical company like a Merk or Pfizeror a number of these other companies that

(22:56):
take drugs through all the way throughclinical trials, and we will need that,
we'll really need their experience. Butwe've done a lot to d risk,
as we say in the community,de risk the opportunities. So we've
shown that we can do it inlarge animals, small animals, large blood

(23:18):
clots, small blood clots, andit works. It works. What about
the large hospital systems here in Georgia, you know, Piedmont, Emory,
you know, I know I missedsomebody, but North Side, all of
them like that, have they boughtinto it? They helping you, they
have, they have helped. Andwe're talking a lot with the group at

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Emory about the opportunities there, butthere's very good centers at all these hospitals,
including the Medical College of Georgia wherewe've initially done this work, and
those could be sites where we couldtest this drug and get it into patients.

(24:04):
So where we need a stroke centerinitially, and those stroke centers are
are at Emory and Medical College atGeorgia and other places in the state,
and that's where we'll focus our efforts. We'd love to get it into patients
here in Georgia and Georgia as quicklyas possible. So those those discussions are

(24:26):
ongoing. Good well. I certainlyI'll do anything I can to help with
strokes, but certainly with als andAlzheimer's. Absolutely absolutely, you're doing great
work. I appreciate you. Iappreciate John, I appreciate you coming here
and talking with us today. Italk uh to people all the time,

(24:49):
and I really want to emphasize thatit takes a large team of people.
Right now, Aaruna has about hfor the employees. We have a large
number of people, as I said, here at University of Georgia that are
working on this as well. Sothank you and thank you behalf of all

(25:11):
the people here at Georgia Absolutely.To find out about aaruna and what they're
doing, visit aurunobio dot com.And if your physician ever asked you to
have your neck scan, do it. It could save your life. I
know, believe me. For questionsof comments on today's program, email me
John Clark at Georgiannewsnetwork dot com.Thanks for listening. I'll talk to you

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next week right here in your localradio station on Georgia Focus