January 19, 2023 • 16 mins
People with Covid-19 often get sick because the body’s inflammatory response to the virus overreacts. To tamp down that inflammation, researchers at the Feinstein Institutes for Medical Research and Cold Spring Harbor Laboratory, turned their sights toward famotidine, the active ingredient in a common over-the-counter heartburn medication with anti-inflammatory potential. On this bonus episode, we speak with the lead researcher of a unique clinical trial testing famotidine for Covid. Tobias Janowitz, MD, PhD, AN Assistant Professor, Cold Spring Harbor Laboratory and adjunct professor at the Feinstein Institutes, shares the results of the study, as well as how the pandemic impacted their approach and led to an early success story for decentralized trials, repurposing medications and the importance of collaborating with other institutions.
Chapters:
- 00:08 - Intro
- 01:39 - Safety, efficacy of famotidine for Covid
- 02:55 - What is famotidine?
- 04:45 - A fully remote trial
- 05:58 - Virtual trial strengths, weaknesses
- 07:00 - Famotidine dosage for heartburn, Covid treatment
- 08:12 - Studying famotidine for Covid
- 09:10 - Decentralized clinical trials
- 10:56 - New paradigms, new problems
- 12:02 - A national focus on decentralized trials
- 13:16 - Collaboration supports clinical excellence
This bonus episode expands on Ep. 102 featuring Onisis Stefas, PharmD, executive director of VIVO Health. Listen to that episode, available in our feed, to learn about the Covid treatments available today.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Host (00:08):
Welcome back to another bonus episode of 20 Minute Health Talk.
I'm Rob Hoell.
Last week, we spoke with
Dr. Onisis Stefas about treatments available today, right now, for people
diagnosed with COVID-19.
He broke these treatments down into three main categories over the
counterwe, prescription, and in hospital.
And in this conversation, Dr.
Stefas walked us through some tips for those with mild cases and how
(00:30):
to manage symptoms at home.
Today, we're talking about another over the counter medication
currently being researched as a potential treatment for COVID.
And it's important to note right up front that this is not an approved
treatment, as studies are still ongoing.
But a phase two trial started right here at the Finestein Institutes
for Medical Research, Northwell's Research arm, in collaboration with
Cold Spring Harbor Laboratory, showed some promise.
(00:53):
Famotidine, also known as Pepcid, is a common over-the-counter drug
used to treat heartburn.
But could it also quell the inflammation fueled by COVID-19?
Our guest today led the team of researchers behind a randomized
outpatient study published in the journal Gut to test that theory out.
Dr. Tobias Janowitz is an assistant professor at Cold Spring Harbor Lab
(01:14):
and an adjunct professor at the Finestein Institutes.
We sat down with him at the Cold Spring Harbor Lab last month to learn
more about this innovative study, which set out not only to evaluate
the effectiveness of high doses of famotidine against COVID, but also to
test the executability of a fully remote trial.
[Music playing]
(01:40):
Dr. Janowitz, welcome to 20 Minutes Health Talk.
Dr. Janowitz (01:41):
Thank you very much for having me.
Host (01:43):
The results of this phase two trial found that famotidine is not only
safe and effective at potentially treating COVID-19, but it could also
open up new avenues of research into treatments and other inflammatory
diseases.
Dr. Janowitz, what is the takeaway from these findings and what happens
next?
Dr. Janowitz (01:58):
Yeah, thank you for asking those questions.
The first specific pharmatodine related result was that we found that
famotidine may help patients recover sooner as they have sustained
inflammation because of COVID-19 and to essentially alleviate this
inflammation early and make patients feel better sooner.
These are preliminary results.
(02:19):
This is not a definitive study, and further studies are necessary, but
we demonstrated this both by looking at patient reported outcome
measures.
So asking patients, how do you feel on a daily basis across a spectrum
of symptoms and tracking how their symptoms resolved and comparing
that for famotidine and placebo in a blinded manner.
(02:41):
And we also tracked the inflammation in their blood using specific
markers of inflammation and seeing how those markers were settling
down slightly sooner when patients were taking fermotradeen compared
to when they were taking placebo.
Host (02:55):
Right.
We talk about this as being possible treatments for other
inflammatory diseases.
I never realized this, but.
But is that what heartburn medication does?
Is that what heartburn does?
Is it causes inflammation?
Dr. Janowitz (03:05):
Yeah.
So the way by which this medication alleviates the symptoms of
heartburn is thought to be to lower the proton concentrations, that
is, causative of the heartburn sensation in the stomach and stomach
area through blocking a specific receptor that modulates this PH in
the stomach.
(03:25):
Mug we and others have found that Famotidine can down regulate the
signaling within the virus infected cells to produce inflammatory
cytokines.
And that's been confirmed now in cell culture and in model systems.
But also we have seen evidence of that in the clinical study that the
(03:48):
inflammatory molecules would be reduced in the circulation and the
signal of the inflammation that radiates out into the organism, into
the whole body, would be dampened sooner.
And so we think that Famotidine works by essentially not pushing back
against the virus, but by helping the body lower the inflammation that
(04:13):
is a consequence of the virus.
Host (04:15):
Right.
And that was part of the problem that people were having when they had
trouble breathing.
Was it because of their lungs were inflamed?
Dr. Janowitz (04:22):
You are absolutely correct.
The sustained inflammation is what makes people unwell and what makes
them sometimes very unwell.
It is important to say, though, that we did not study the patients who
were very unwell in our trial.
So I cannot comment as to the efficacy or the potential efficacy of
Farmotidine in the context of severe COVID.
Host (04:44):
It's fascinating.
And I think what's great about this study too, is that you brought
this study to the patients in their homes.
Tell us a little bit about how that worked.
Dr. Janowitz (04:51):
Yeah, that's a great question and that's a really important
transferable point of this study.
What we initially set out for, as you have to imagine, when we planned
the study, there were no vaccines available, there were no treatments
available, and this was a very contagious disease with potentially
grievous outcome to patients.
So we spent long and hard thinking about how can we deliver a study in
(05:11):
a safe manner?
And together with the Feinstein Institute's, northwell Health and Cold
Spring Harbor, we came up with a paradigm where we would essentially
enroll patients remotely and then take the study medication and the
study equipment to their place of residence.
With overnight delivery after they had consented to participate in the
trial and then deliver the trial whilst they were in the comfort of
(05:34):
their own home.
So, in other words, these patients never had to leave the home, travel
to the hospital, expose other people on the way to the potentially
infectious and grievous condition that they were having at that point.
And so we were able to keep not only them, but also the other people
safe as we were delivering the study.
And that was a really important outcome that that was fee feasible to
(05:56):
deliver a study in that manner.
Host (05:58):
Is this a better way to do a study like for.
People to be more comfortable in a situation where, like you said,
there's no fear of actually having to travel and come in.
And also, how would you monitor them while they're doing this at home?
Dr. Janowitz (06:07):
Yeah, I think there are strength and weaknesses.
To be fair to an approach like this, if you had a serious condition,
you could not just study patients remotely.
You would have to have them under physician supervision.
And some trials have to be delivered in the hospital and in the safety
of the hospital.
Some drugs are given by infusions.
Sometimes patients need to be close to an intensive care unit if they
(06:28):
were to get less well.
But in certain conditions when perhaps the patient is not quite so
severely affected and when perhaps the patient would prefer to be at
home.
That can be the case in certain infectious conditions.
But it can also be the case in conditions that make you feel unwell,
like, for example, progressive cancer, which is something that I think
(06:51):
a lot about and where we were initially planning to deliver this
disease paradigm, this trial paradigm, which we then lifted to apply
it to the COVID situation.
Host (07:02):
So getting back to this famotidine trial, how were the patients
taking the medication?
Dr. Janowitz (07:06):
So what we did is we developed with a company way to essentially over
capsulate the medication so that it was indistinguishable between
placebo and the treatment.
They were coming into a wide, large capsule that could be swallowed
orally, and they would take this medication three times daily, albeit
(07:27):
at a much higher dose than you would take it over the counter for
heartburn.
So we delivered 80 milligrams three times daily as a capsule, and
rather than 20 milligrams once to twice daily.
Host (07:38):
And I think that's what's so fascinating about research and clinical
trials.
So many times, when you're looking for one thing, it may unlock
something else.
Dr. Janowitz (07:46):
Yeah, sure.
There are many examples, especially in my area of expertise, true
expertise in medical oncology, where initial studies have been
conducted to find out if a drug works in a certain way, in a certain
condition.
And people realize that perhaps that's not the case, but something
else might be the case.
And then they can take it back into the laboratory, confirm that
(08:07):
secondary finding, and then bring it back into clinical trials to
perhaps make an impact on another condition.
Host (08:12):
What was the timeline of the study?
So we initially had some indication that perhaps patients who were on
famotidine were doing slightly better.
And so the first thing that we did, we did a case series, which is
preliminary clinical research.
Then we developed this phase two clinical trial, which is a randomized
(08:35):
placebo control trial.
So that's a strong study, but with small patient numbers.
So it's not an efficacy study.
It looks for ways to how to discover efficacy in further clinical
trials.
And that trial was started in July after we published the case series
July 2020 and the results were published
(09:00):
Early this year, in 2022.
I think what is important from my perspective is the other extended
findings that we learned from the trial, because those we are hoping
to take forward.
So when you say take the other findings forward, what do you can you
expand on that?
Dr. Janowitz (09:14):
Yeah, so the things that were really important for us was to
demonstrate that firstly, a trial could be delivered in this remote,
decentralized manner.
So you could imagine this is perhaps transferable.
Say if you wanted to study a rare condition across the United States
where you have 300, 400 patients spread over an entire country, and
(09:35):
you could have a central hub ship out the trial to the patients and
somebody from Texas, somebody from Maine and somebody from Vermont
could sort of enroll in this study and be part of the study, and it
could be safely delivered, perhaps with a central hub where we collect
data.
And so that opens up a completely new way to perhaps deliver clinical
(09:58):
studies and that is worth to explore further.
The other point is the study was very inclusive and that is one of the
big challenges of delivering health care, as we are now trying to
develop new clinical trials and trial paradigms to reach out to
(10:20):
patients and patient populations who would not normally participate in
clinical trials so much.
And we had 33% black African American participants in the study, 25%
Hispanic patients in our study.
And we believe that one of the reasons why that was possible was
because we made it easier for them to enter clinical trials and to
(10:43):
lower the access barrier because we would take the sort of effort and
the cost of the clinical trial down by bringing the trial to their own
home.
Host (10:56):
Yeah, I think it's so much easier, right.
When you're doing something in your home, it's much more easy to be a
part of that.
Does that create problems as far as, like, how do you track, how do
you make sure they're taking their medication?
How do you know that everything is going to be correct?
Dr. Janowitz (11:10):
Yes, of course.
New paradigms, new problems, new challenges, let's say.
And these challenges have to be taken one step at a time.
We were able to follow each patient every day by having a dedicated
person who would call them up, who would monitor their data that they
would send in every day.
With regards to the drug concordance that you're asking about, we
(11:32):
would tackle that in two fronts.
One would be to ask the patients on a daily basis, have you taken your
medication?
And record their answers.
The other approach that we took, we took a blood sample and then used
the facility here at Cold Spring Harbor Laboratory to trace the blood
and to trace the medication in the blood and thereby be able to
(11:53):
determine exactly what concentration of the blood of the drug was in
the blood.
At any one time.
Host (12:01):
So you kind of would know anyway.
Dr. Janowitz (12:02):
Correct.
Host (12:03):
Do you feel like this type of thing is going to help get more people
involved in more studies across the board?
Dr. Janowitz (12:08):
Absolutely.
And that's the key point and key message that I think I would like to
put out here.
This study is one contributor to shifting the paradigm of how we
deliver clinical trials.
We are not the only people to think about this.
This is a national agenda.
There are many people who are trying to do the right thing.
The government is coordinating it in that manner as well.
(12:31):
And the NIH is encouraging people to think about decentralized trials
and using remote clinical trial monitoring as an enrichment for
clinical research.
I think what is important is we were able to do this, admittedly with
a small number of patients.
55 patients were enrolled in the end, but we were able to collect
(12:52):
their data, deeply, analyze it, write up the results and publish them
in sort of some total of 18 months from the conception of the study to
the report of the results.
And I think that's a really important sort of benchmark and an early
contribution to delivering this type of clinical study so that others
(13:12):
can learn from the things that went well and from the challenges that
we encountered.
Host (13:17):
That's great.
This trial was a collaboration between Finest and institutes for
medical research, cold Spring Harbor Laboratories.
And you said this alliance unlocks potential on both sites.
Can you explain what you mean and how other institutes could benefit
from this model?
Dr. Janowitz (13:31):
Yeah, I can.
Thank you for asking that, because I think what is really important to
recognize is as you take on challenges where individual components
have to be delivered at the highest level, you sometimes have to bring
partners together that are experienced at the respective components.
Cold Spring Harbor is a center of excellence for basic research and
(13:54):
has made fundamental contributions there and has the facilities to
drive true deep research.
The Finestines Institutes are a great translational research center
where patients where some groups work a bit closer to clinical
research, and some groups work on fundamental research.
So they have this translational arm bringing research closer to the
(14:16):
patient and bringing the patient closer to research.
And Northwell Health is an institute that is extremely strong at
healthcare delivery and operations.
And so each component brought their own expertise to the table to
deliver together a clinical trial that none of them could have
delivered in isolation.
So I would go as far as saying not only was this made it the trial
(14:41):
easier, it was a necessity to bring these three groups together with
their respective strength in order to be able to deliver this.
And with regards to what can others learn from this, there are, of
course, within the United States and within over the globe, other
centers where.
Research institutes and clinical entities work closely together.
(15:04):
But I think it is really important to embrace this partnership of
fundamental research and clinical excellence as we move science
forward and as we try to deliver better science for the benefit of
patients.
Host (15:21):
Now more studies are underway building on these findings.
Among this research search was another phase II trial from the fine
scene institutes, which showed that famotidine may also influence
nerve signaling from the body to the brain.
That paper was published in May in the journal Molecular Medicine.
And that does it for this bonus episode of 20-Minute Health Talk.
Thank you to Dr.
Janowitz, as well as the Feinstein Institutes and Cold Spring Harbor
(15:44):
researchers, administrators and participants for their work and
dedication.
Thanks to you, the listener, for tuning in.
I'm Rob Hoell, and on behalf of my cohost, Sandra Lindsay, who is
currently in Jamaica supporting a Northwell led mission trip, a topic
I'm pretty sure you'll be hearing about very soon in the near future.
Have a great day and stay safe.
Welcome back to another bonus episode of 20 Minute Health Talk.
I'm Rob Hoell.
Last week, we spoke with
Dr. Onisis Stefas about treatments available today, right now, for people
diagnosed with COVID-19.
He broke these treatments down into three main categories over the
counterwe, prescription, and in hospital.
And in this conversation, Dr.
Stefas walked us through some tips for those with mild cases and how
(00:30):
to manage symptoms at home.
Today, we're talking about another over the counter medication
currently being researched as a potential treatment for COVID.
And it's important to note right up front that this is not an approved
treatment, as studies are still ongoing.
But a phase two trial started right here at the Finestein Institutes
for Medical Research, Northwell's Research arm, in collaboration with
Cold Spring Harbor Laboratory, showed some promise.
(00:53):
Famotidine, also known as Pepcid, is a common over-the-counter drug
used to treat heartburn.
But could it also quell the inflammation fueled by COVID-19?
Our guest today led the team of researchers behind a randomized
outpatient study published in the journal Gut to test that theory out.
Dr. Tobias Janowitz is an assistant professor at Cold Spring Harbor Lab
(01:14):
and an adjunct professor at the Finestein Institutes.
We sat down with him at the Cold Spring Harbor Lab last month to learn
more about this innovative study, which set out not only to evaluate
the effectiveness of high doses of famotidine against COVID, but also to
test the executability of a fully remote trial.
[Music playing]
(01:40):
Dr. Janowitz, welcome to 20 Minutes Health Talk.
Dr. Janowitz (01:41):
Thank you very much for having me.
Host (01:43):
The results of this phase two trial found that famotidine is not only
safe and effective at potentially treating COVID-19, but it could also
open up new avenues of research into treatments and other inflammatory
diseases.
Dr. Janowitz, what is the takeaway from these findings and what happens
next?
Dr. Janowitz (01:58):
Yeah, thank you for asking those questions.
The first specific pharmatodine related result was that we found that
famotidine may help patients recover sooner as they have sustained
inflammation because of COVID-19 and to essentially alleviate this
inflammation early and make patients feel better sooner.
These are preliminary results.
(02:19):
This is not a definitive study, and further studies are necessary, but
we demonstrated this both by looking at patient reported outcome
measures.
So asking patients, how do you feel on a daily basis across a spectrum
of symptoms and tracking how their symptoms resolved and comparing
that for famotidine and placebo in a blinded manner.
(02:41):
And we also tracked the inflammation in their blood using specific
markers of inflammation and seeing how those markers were settling
down slightly sooner when patients were taking fermotradeen compared
to when they were taking placebo.
Host (02:55):
Right.
We talk about this as being possible treatments for other
inflammatory diseases.
I never realized this, but.
But is that what heartburn medication does?
Is that what heartburn does?
Is it causes inflammation?
Dr. Janowitz (03:05):
Yeah.
So the way by which this medication alleviates the symptoms of
heartburn is thought to be to lower the proton concentrations, that
is, causative of the heartburn sensation in the stomach and stomach
area through blocking a specific receptor that modulates this PH in
the stomach.
(03:25):
Mug we and others have found that Famotidine can down regulate the
signaling within the virus infected cells to produce inflammatory
cytokines.
And that's been confirmed now in cell culture and in model systems.
But also we have seen evidence of that in the clinical study that the
(03:48):
inflammatory molecules would be reduced in the circulation and the
signal of the inflammation that radiates out into the organism, into
the whole body, would be dampened sooner.
And so we think that Famotidine works by essentially not pushing back
against the virus, but by helping the body lower the inflammation that
(04:13):
is a consequence of the virus.
Host (04:15):
Right.
And that was part of the problem that people were having when they had
trouble breathing.
Was it because of their lungs were inflamed?
Dr. Janowitz (04:22):
You are absolutely correct.
The sustained inflammation is what makes people unwell and what makes
them sometimes very unwell.
It is important to say, though, that we did not study the patients who
were very unwell in our trial.
So I cannot comment as to the efficacy or the potential efficacy of
Farmotidine in the context of severe COVID.
Host (04:44):
It's fascinating.
And I think what's great about this study too, is that you brought
this study to the patients in their homes.
Tell us a little bit about how that worked.
Dr. Janowitz (04:51):
Yeah, that's a great question and that's a really important
transferable point of this study.
What we initially set out for, as you have to imagine, when we planned
the study, there were no vaccines available, there were no treatments
available, and this was a very contagious disease with potentially
grievous outcome to patients.
So we spent long and hard thinking about how can we deliver a study in
(05:11):
a safe manner?
And together with the Feinstein Institute's, northwell Health and Cold
Spring Harbor, we came up with a paradigm where we would essentially
enroll patients remotely and then take the study medication and the
study equipment to their place of residence.
With overnight delivery after they had consented to participate in the
trial and then deliver the trial whilst they were in the comfort of
(05:34):
their own home.
So, in other words, these patients never had to leave the home, travel
to the hospital, expose other people on the way to the potentially
infectious and grievous condition that they were having at that point.
And so we were able to keep not only them, but also the other people
safe as we were delivering the study.
And that was a really important outcome that that was fee feasible to
(05:56):
deliver a study in that manner.
Host (05:58):
Is this a better way to do a study like for.
People to be more comfortable in a situation where, like you said,
there's no fear of actually having to travel and come in.
And also, how would you monitor them while they're doing this at home?
Dr. Janowitz (06:07):
Yeah, I think there are strength and weaknesses.
To be fair to an approach like this, if you had a serious condition,
you could not just study patients remotely.
You would have to have them under physician supervision.
And some trials have to be delivered in the hospital and in the safety
of the hospital.
Some drugs are given by infusions.
Sometimes patients need to be close to an intensive care unit if they
(06:28):
were to get less well.
But in certain conditions when perhaps the patient is not quite so
severely affected and when perhaps the patient would prefer to be at
home.
That can be the case in certain infectious conditions.
But it can also be the case in conditions that make you feel unwell,
like, for example, progressive cancer, which is something that I think
(06:51):
a lot about and where we were initially planning to deliver this
disease paradigm, this trial paradigm, which we then lifted to apply
it to the COVID situation.
Host (07:02):
So getting back to this famotidine trial, how were the patients
taking the medication?
Dr. Janowitz (07:06):
So what we did is we developed with a company way to essentially over
capsulate the medication so that it was indistinguishable between
placebo and the treatment.
They were coming into a wide, large capsule that could be swallowed
orally, and they would take this medication three times daily, albeit
(07:27):
at a much higher dose than you would take it over the counter for
heartburn.
So we delivered 80 milligrams three times daily as a capsule, and
rather than 20 milligrams once to twice daily.
Host (07:38):
And I think that's what's so fascinating about research and clinical
trials.
So many times, when you're looking for one thing, it may unlock
something else.
Dr. Janowitz (07:46):
Yeah, sure.
There are many examples, especially in my area of expertise, true
expertise in medical oncology, where initial studies have been
conducted to find out if a drug works in a certain way, in a certain
condition.
And people realize that perhaps that's not the case, but something
else might be the case.
And then they can take it back into the laboratory, confirm that
(08:07):
secondary finding, and then bring it back into clinical trials to
perhaps make an impact on another condition.
Host (08:12):
What was the timeline of the study?
So we initially had some indication that perhaps patients who were on
famotidine were doing slightly better.
And so the first thing that we did, we did a case series, which is
preliminary clinical research.
Then we developed this phase two clinical trial, which is a randomized
(08:35):
placebo control trial.
So that's a strong study, but with small patient numbers.
So it's not an efficacy study.
It looks for ways to how to discover efficacy in further clinical
trials.
And that trial was started in July after we published the case series
July 2020 and the results were published
(09:00):
Early this year, in 2022.
I think what is important from my perspective is the other extended
findings that we learned from the trial, because those we are hoping
to take forward.
So when you say take the other findings forward, what do you can you
expand on that?
Dr. Janowitz (09:14):
Yeah, so the things that were really important for us was to
demonstrate that firstly, a trial could be delivered in this remote,
decentralized manner.
So you could imagine this is perhaps transferable.
Say if you wanted to study a rare condition across the United States
where you have 300, 400 patients spread over an entire country, and
(09:35):
you could have a central hub ship out the trial to the patients and
somebody from Texas, somebody from Maine and somebody from Vermont
could sort of enroll in this study and be part of the study, and it
could be safely delivered, perhaps with a central hub where we collect
data.
And so that opens up a completely new way to perhaps deliver clinical
(09:58):
studies and that is worth to explore further.
The other point is the study was very inclusive and that is one of the
big challenges of delivering health care, as we are now trying to
develop new clinical trials and trial paradigms to reach out to
(10:20):
patients and patient populations who would not normally participate in
clinical trials so much.
And we had 33% black African American participants in the study, 25%
Hispanic patients in our study.
And we believe that one of the reasons why that was possible was
because we made it easier for them to enter clinical trials and to
(10:43):
lower the access barrier because we would take the sort of effort and
the cost of the clinical trial down by bringing the trial to their own
home.
Host (10:56):
Yeah, I think it's so much easier, right.
When you're doing something in your home, it's much more easy to be a
part of that.
Does that create problems as far as, like, how do you track, how do
you make sure they're taking their medication?
How do you know that everything is going to be correct?
Dr. Janowitz (11:10):
Yes, of course.
New paradigms, new problems, new challenges, let's say.
And these challenges have to be taken one step at a time.
We were able to follow each patient every day by having a dedicated
person who would call them up, who would monitor their data that they
would send in every day.
With regards to the drug concordance that you're asking about, we
(11:32):
would tackle that in two fronts.
One would be to ask the patients on a daily basis, have you taken your
medication?
And record their answers.
The other approach that we took, we took a blood sample and then used
the facility here at Cold Spring Harbor Laboratory to trace the blood
and to trace the medication in the blood and thereby be able to
(11:53):
determine exactly what concentration of the blood of the drug was in
the blood.
At any one time.
Host (12:01):
So you kind of would know anyway.
Dr. Janowitz (12:02):
Correct.
Host (12:03):
Do you feel like this type of thing is going to help get more people
involved in more studies across the board?
Dr. Janowitz (12:08):
Absolutely.
And that's the key point and key message that I think I would like to
put out here.
This study is one contributor to shifting the paradigm of how we
deliver clinical trials.
We are not the only people to think about this.
This is a national agenda.
There are many people who are trying to do the right thing.
The government is coordinating it in that manner as well.
(12:31):
And the NIH is encouraging people to think about decentralized trials
and using remote clinical trial monitoring as an enrichment for
clinical research.
I think what is important is we were able to do this, admittedly with
a small number of patients.
55 patients were enrolled in the end, but we were able to collect
(12:52):
their data, deeply, analyze it, write up the results and publish them
in sort of some total of 18 months from the conception of the study to
the report of the results.
And I think that's a really important sort of benchmark and an early
contribution to delivering this type of clinical study so that others
(13:12):
can learn from the things that went well and from the challenges that
we encountered.
Host (13:17):
That's great.
This trial was a collaboration between Finest and institutes for
medical research, cold Spring Harbor Laboratories.
And you said this alliance unlocks potential on both sites.
Can you explain what you mean and how other institutes could benefit
from this model?
Dr. Janowitz (13:31):
Yeah, I can.
Thank you for asking that, because I think what is really important to
recognize is as you take on challenges where individual components
have to be delivered at the highest level, you sometimes have to bring
partners together that are experienced at the respective components.
Cold Spring Harbor is a center of excellence for basic research and
(13:54):
has made fundamental contributions there and has the facilities to
drive true deep research.
The Finestines Institutes are a great translational research center
where patients where some groups work a bit closer to clinical
research, and some groups work on fundamental research.
So they have this translational arm bringing research closer to the
(14:16):
patient and bringing the patient closer to research.
And Northwell Health is an institute that is extremely strong at
healthcare delivery and operations.
And so each component brought their own expertise to the table to
deliver together a clinical trial that none of them could have
delivered in isolation.
So I would go as far as saying not only was this made it the trial
(14:41):
easier, it was a necessity to bring these three groups together with
their respective strength in order to be able to deliver this.
And with regards to what can others learn from this, there are, of
course, within the United States and within over the globe, other
centers where.
Research institutes and clinical entities work closely together.
(15:04):
But I think it is really important to embrace this partnership of
fundamental research and clinical excellence as we move science
forward and as we try to deliver better science for the benefit of
patients.
Host (15:21):
Now more studies are underway building on these findings.
Among this research search was another phase II trial from the fine
scene institutes, which showed that famotidine may also influence
nerve signaling from the body to the brain.
That paper was published in May in the journal Molecular Medicine.
And that does it for this bonus episode of 20-Minute Health Talk.
Thank you to Dr.
Janowitz, as well as the Feinstein Institutes and Cold Spring Harbor
(15:44):
researchers, administrators and participants for their work and
dedication.
Thanks to you, the listener, for tuning in.
I'm Rob Hoell, and on behalf of my cohost, Sandra Lindsay, who is
currently in Jamaica supporting a Northwell led mission trip, a topic
I'm pretty sure you'll be hearing about very soon in the near future.
Have a great day and stay safe.
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