This week on BioTech Nation, Dr. Raza Bokhari, CEO of Medicus Pharma, shares a new non-surgical treatment approach for basal cell carcinoma, the most common form of skin cancer. Their novel microneedle patch delivers a powerful cancer drug directly into the skin, avoiding the scarring, cost, and discomfort of Mohs surgery. With promising phase 2 trials underway in the US and Europe, this could change the way we treat millions of skin cancer cases every year.
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Dr. Moira Gunn (00:11):
Each year, over three million people in The U.
S. Are diagnosed with nonmelanoma skin cancer. Over eight
hundred thousand undergo what iscalled Mohs surgery, A new
approach to treating this cancerand going further, avoiding Mohs
surgery, is in ongoing phase twostudies in both The US and
(00:33):
Europe. Doctor.
Raza Bokhari is the CEO ofMedicus Pharma. I want to start
here with what has beendescribed to me as the most
common kind of skin cancer,basal cell carcinoma. What is
it? How many people get it? Howserious is it?
Dr. Raza Bokhari (00:54):
Non melanoma skin diseases represent the most
common ailments of the skin.Basal cell carcinoma amongst
those is the most commonest ofall, with five million new cases
emerging just in The UnitedStates. It is a form of cancer,
(01:19):
which is wherever there isultraviolet radiation or
exposure to sunlight and fairskinned population, that is the
breeding ground for this type ofcancer. The good news is that it
is a slow growing cancer andwith an effective treatment, it
(01:45):
does not cause any morbidity ormortality. And in Western
Hemisphere, there is a surgicalintervention which is considered
a definitive treatment where thecancer is curettaged and removed
(02:09):
and is treated quiteeffectively, but painfully,
expensively, and aestheticallynot in a very pleasing fashion.
Dr. Moira Gunn (02:20):
And are you talking about the so called Mohs
surgery? M O H, Mohs surgery?
Dr. Raza Bokhari (02:26):
That is correct. Mohs surgery is a
modified surgical procedure inthe hands of trained
dermatologists with subspecialtycertification, which there are
about, 5,000 or so in The UnitedStates that carry out these Mohs
(02:46):
procedures, which add up toabout 1,000,000 or so procedures
every year.
Dr. Moira Gunn (02:54):
Now, as I understand it, there are also
topical medications, right?
Dr. Raza Bokhari (03:01):
There is an approved topical application.
Active compound is fivethioflourourocell, but these
applications, these topicalapplications are more
therapeutic for a superficialtype of basal cell carcinoma,
(03:24):
which is the smaller subset. Thefive million new cases that
emerge every year, sixty percentto seventy percent are the
nodular type of basal cellcarcinoma, followed by a
superficial type, whichrepresent twenty percent to
(03:47):
twenty five percent. Thesetopical applications have
demonstrated efficacy in thesuperficial type, their outcome
of treatment in the nodular typeis not very promising.
Dr. Moira Gunn (04:07):
Now, let me ask you this, if you can get that
topical into those nodules, isit effective or are those a
different kind of a cancer?
Dr. Raza Bokhari (04:19):
So the topical application, the active
compound, of fivetheofluorouracil, perhaps if it
will find its way into theinterstitial fluid
transdermally, perhaps wouldresult in a therapeutic positive
(04:40):
outcome. But when you apply itand rub it onto the skin, it
does not go past thesubcutaneous tissue of the fatty
layer beyond the skin, below theskin.
Dr. Moira Gunn (04:54):
Well, now we get to Medicus Pharma, and you're
definitely trying to get belowthat superficial layer. What are
you doing?
Dr. Raza Bokhari (05:05):
By delivering a known chemotherapeutic agent
called Doxyrubicin. And wedelivered this transdermally by
tip loading this on micro needlearrays and apply the patch at
(05:25):
the site of the lesion. And asit penetrates the dermis and
touches the interstitial fluid,these needles dissolve and
deliver Doxyrubicin at the siteof the lesion and through an
(05:48):
immunogenic response cause celldeath or cell apoptosis.
Dr. Moira Gunn (05:54):
Now sticking with this patch, what we're
talking about, first of all, isthe patch itself has these tiny
needles that once they go so youcan you can get all over that
skin area and in insert theneedles down, but then the
needles dissolve.
Dr. Raza Bokhari (06:14):
These tiny micro needle arrays, seven fifty
micron in size, 400 of theseassembled in a patch, which is
not more than 15 by 15millimeter is tip loaded with
(06:35):
Doxy Rubicon and these needlespenetrate the skin and when they
enter the interstitial fluid,they dissolve and initiate an
immunogenic response and causecell death.
Dr. Moira Gunn (06:54):
Now let me ask you, this is a different drug
than we were talking about whenyou talked about a topical
coverage,
Dr. Raza Bokhari (07:03):
That is correct. The topical application
which is approved is fivethioflourouacil. It is also a
chemotherapeutic agent, but adifferent chemical composition.
Toxorubicin is a very potentcell killer. It has been around
(07:32):
for forty plus years.
It is called a it's a killer. Itkills. It does not discriminate.
Whenever it enters into anycells, healthy cells, cancerous
cells, it kills. It is so badthat, when I was graduating from
(07:55):
medical school many, many moonsago, we would all read about
Doxyrubicin and the toxic sideeffects that would cause red
death.
So it is very potent cardiotoxicagent while it kills the cancer
cells, but it also causesserious adverse side effects. So
(08:17):
mostly, this compound has beenbenched and is seldom used, for
active treatment in modernmedicine.
Dr. Moira Gunn (08:28):
So why can you use it here?
Dr. Raza Bokhari (08:31):
We are microdosing. We are using this
drug, this very potent drug inmicrons, in 100 and in two
hundred micrograms. So these aremicro doses which are through
these uniquely designed needleare being delivered directly to
(08:54):
the site of the lesion withoutentering the bloodstream. And
the company in its phase onesafety and tolerability study,
we delivered Doxyrubicin at thesite of the lesion without any
serious, systemic or localadverse effects. And so this
(09:21):
uniquely designed needle did thejob by not only delivering the
medication, realising thepotency and efficacy without any
adverse effects, which is whatwe believe is a breakthrough
technology.
Dr. Moira Gunn (09:40):
Now, do you determine that the cancer is
really gone in these studies?
Dr. Raza Bokhari (09:49):
That's a very important question. In the
clinical trial, when we applythis patch in three office, in
an office setting, in threethirty minute sitting one week
apart, we call the patient backfor visual inspection. And at
(10:13):
that time, when we see that thelesion has cleared, which in
more than sixty percent of thepatients, it does demonstrate
that it has cleared, we do anexcisional biopsy. So we cut out
(10:34):
the area where the cancer was,excise it, and do an
histological examination toconfirm that there are no cancer
cells left. Post approval, therewill be no need to do that
(10:54):
excision to confirm histologicalfindings.
But in the trial, that is how weconfirm that what is visually
has shown that the cancer cellshave been cured. This is also
confirmed through thishistological examination.
Dr. Moira Gunn (11:16):
Doctor. Raza Bokhari is the CEO of Medicus
Pharma. More information on howto participate in the ongoing
phase two study in both The U.S. And in Europe is available at
medicuspharma.com.
Each year, over three million people in The U.
S. Are diagnosed with nonmelanoma skin cancer. Over eight
hundred thousand undergo what iscalled Mohs surgery, A new
approach to treating this cancerand going further, avoiding Mohs
surgery, is in ongoing phase twostudies in both The US and
(00:33):
Europe. Doctor.
Raza Bokhari is the CEO ofMedicus Pharma. I want to start
here with what has beendescribed to me as the most
common kind of skin cancer,basal cell carcinoma. What is
it? How many people get it? Howserious is it?
Dr. Raza Bokhari (00:54):
Non melanoma skin diseases represent the most
common ailments of the skin.Basal cell carcinoma amongst
those is the most commonest ofall, with five million new cases
emerging just in The UnitedStates. It is a form of cancer,
(01:19):
which is wherever there isultraviolet radiation or
exposure to sunlight and fairskinned population, that is the
breeding ground for this type ofcancer. The good news is that it
is a slow growing cancer andwith an effective treatment, it
(01:45):
does not cause any morbidity ormortality. And in Western
Hemisphere, there is a surgicalintervention which is considered
a definitive treatment where thecancer is curettaged and removed
(02:09):
and is treated quiteeffectively, but painfully,
expensively, and aestheticallynot in a very pleasing fashion.
Dr. Moira Gunn (02:20):
And are you talking about the so called Mohs
surgery? M O H, Mohs surgery?
Dr. Raza Bokhari (02:26):
That is correct. Mohs surgery is a
modified surgical procedure inthe hands of trained
dermatologists with subspecialtycertification, which there are
about, 5,000 or so in The UnitedStates that carry out these Mohs
(02:46):
procedures, which add up toabout 1,000,000 or so procedures
every year.
Dr. Moira Gunn (02:54):
Now, as I understand it, there are also
topical medications, right?
Dr. Raza Bokhari (03:01):
There is an approved topical application.
Active compound is fivethioflourourocell, but these
applications, these topicalapplications are more
therapeutic for a superficialtype of basal cell carcinoma,
(03:24):
which is the smaller subset. Thefive million new cases that
emerge every year, sixty percentto seventy percent are the
nodular type of basal cellcarcinoma, followed by a
superficial type, whichrepresent twenty percent to
(03:47):
twenty five percent. Thesetopical applications have
demonstrated efficacy in thesuperficial type, their outcome
of treatment in the nodular typeis not very promising.
Dr. Moira Gunn (04:07):
Now, let me ask you this, if you can get that
topical into those nodules, isit effective or are those a
different kind of a cancer?
Dr. Raza Bokhari (04:19):
So the topical application, the active
compound, of fivetheofluorouracil, perhaps if it
will find its way into theinterstitial fluid
transdermally, perhaps wouldresult in a therapeutic positive
(04:40):
outcome. But when you apply itand rub it onto the skin, it
does not go past thesubcutaneous tissue of the fatty
layer beyond the skin, below theskin.
Dr. Moira Gunn (04:54):
Well, now we get to Medicus Pharma, and you're
definitely trying to get belowthat superficial layer. What are
you doing?
Dr. Raza Bokhari (05:05):
By delivering a known chemotherapeutic agent
called Doxyrubicin. And wedelivered this transdermally by
tip loading this on micro needlearrays and apply the patch at
(05:25):
the site of the lesion. And asit penetrates the dermis and
touches the interstitial fluid,these needles dissolve and
deliver Doxyrubicin at the siteof the lesion and through an
(05:48):
immunogenic response cause celldeath or cell apoptosis.
Dr. Moira Gunn (05:54):
Now sticking with this patch, what we're
talking about, first of all, isthe patch itself has these tiny
needles that once they go so youcan you can get all over that
skin area and in insert theneedles down, but then the
needles dissolve.
Dr. Raza Bokhari (06:14):
These tiny micro needle arrays, seven fifty
micron in size, 400 of theseassembled in a patch, which is
not more than 15 by 15millimeter is tip loaded with
(06:35):
Doxy Rubicon and these needlespenetrate the skin and when they
enter the interstitial fluid,they dissolve and initiate an
immunogenic response and causecell death.
Dr. Moira Gunn (06:54):
Now let me ask you, this is a different drug
than we were talking about whenyou talked about a topical
coverage,
Dr. Raza Bokhari (07:03):
That is correct. The topical application
which is approved is fivethioflourouacil. It is also a
chemotherapeutic agent, but adifferent chemical composition.
Toxorubicin is a very potentcell killer. It has been around
(07:32):
for forty plus years.
It is called a it's a killer. Itkills. It does not discriminate.
Whenever it enters into anycells, healthy cells, cancerous
cells, it kills. It is so badthat, when I was graduating from
(07:55):
medical school many, many moonsago, we would all read about
Doxyrubicin and the toxic sideeffects that would cause red
death.
So it is very potent cardiotoxicagent while it kills the cancer
cells, but it also causesserious adverse side effects. So
(08:17):
mostly, this compound has beenbenched and is seldom used, for
active treatment in modernmedicine.
Dr. Moira Gunn (08:28):
So why can you use it here?
Dr. Raza Bokhari (08:31):
We are microdosing. We are using this
drug, this very potent drug inmicrons, in 100 and in two
hundred micrograms. So these aremicro doses which are through
these uniquely designed needleare being delivered directly to
(08:54):
the site of the lesion withoutentering the bloodstream. And
the company in its phase onesafety and tolerability study,
we delivered Doxyrubicin at thesite of the lesion without any
serious, systemic or localadverse effects. And so this
(09:21):
uniquely designed needle did thejob by not only delivering the
medication, realising thepotency and efficacy without any
adverse effects, which is whatwe believe is a breakthrough
technology.
Dr. Moira Gunn (09:40):
Now, do you determine that the cancer is
really gone in these studies?
Dr. Raza Bokhari (09:49):
That's a very important question. In the
clinical trial, when we applythis patch in three office, in
an office setting, in threethirty minute sitting one week
apart, we call the patient backfor visual inspection. And at
(10:13):
that time, when we see that thelesion has cleared, which in
more than sixty percent of thepatients, it does demonstrate
that it has cleared, we do anexcisional biopsy. So we cut out
(10:34):
the area where the cancer was,excise it, and do an
histological examination toconfirm that there are no cancer
cells left. Post approval, therewill be no need to do that
(10:54):
excision to confirm histologicalfindings.
But in the trial, that is how weconfirm that what is visually
has shown that the cancer cellshave been cured. This is also
confirmed through thishistological examination.
Dr. Moira Gunn (11:16):
Doctor. Raza Bokhari is the CEO of Medicus
Pharma. More information on howto participate in the ongoing
phase two study in both The U.S. And in Europe is available at
medicuspharma.com.
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