Medicus Pharma provides additional Phase 2 data for SkinJect Cancer therapy

Welcome back inside our proactive newsroom.

And joining me now is Dr. Raza Bacari.

He is the CEO of Medicus Farman.

Dr. Bacari, it's nice to see again.

How are you?

I'm doing really well, Steve.

Thank you so much.

The spring is finally around the corner.

It is, it is.

It's always good news.

And that's what you're here to share a little more details

in your phase two clinical trial for your skin

jet cancer therapy.

And you and I talked last week about some of the stuff

that you were seeing some top line down.

You've got a bit more data to share with us today.

Very positive news from what you're seeing, I would imagine.

Absolutely, Steve.

We couldn't be more excited to what we have seen in the phase

two data set for our novel therapy

to treat basal cell carcinoma noninvasively,

which is an unmet medical need.

And what the data set has shown that three out of four

treated patients very likely would not

require most surgery.

So as your viewers would know that there

are about nearly five million new cases

are diagnosed every year.

About a million most procedures can be carried out

in United States because there are so many trained modes

of surgeon.

So there is a backlog in this an unmet medical need.

In our proof of concept study, which

has been very focused on the clinical clearance right

from the outset, now shows for the 200 microgram cohort

where we have a day 57 of exigenal biopsy, 73% clinical

or visual clearance.

So for a clinician, there is a very promising

and where three out of four treated patients

don't require more and they get put on a follow-up protocol

and perhaps some of them would come back with their recurrence.

But nonetheless, it helps address the backlog.

But more importantly, gives us enough of a data set

to enter into a end of phase two meeting with the FDA

for how to design the pivotal study,

but also accelerate partnering discussion.

So it's an exciting outcome, which further

a little bit requires a interpretation

that our micro needles by itself, which

are pattern protected, also lend biological activity.

And we have known that right from the outset.

So tip loading them with the doxy-rubusin creates

the separation of a higher clinical clearance three out

of four times.

So this is a very promising outcome for us.

Yeah, I was reading more about the study itself

and how you were doing things.

And I noticed that there was an active placebo

and that was fairly, it's not very uncommon

to be using something like that.

Was that designed specifically in a way

that you wanted to have this one done?

So yes, we did.

It's a novel study.

I think there is a nomenclature.

The description of the study could be misleading

because the descriptions say this

a placebo-controlled triple-arm double-blind study.

Well, the placebo, which is the micro needle array

without the doxy-rubusin, is also an active arm.

It is not a blank, our entire patterns

that we have, it is a composition of matter

and a method of use pattern that we have

is around those per boxy methyl cellulose micro needles

that lend a biological activity by itself.

Now, when they are tip loaded with the doxy-rubusin,

they get supercharged and in our phase one study

which was completed in 2021,

it was a dose escalation study

ranging from 25 microgram to 200 microgram.

And our current study where we only used 100 microgram

and 200 microgram on and compared that with the,

the, the, the, the blank or the non-micro-doxy-rubusin

tip loaded arm, it shows clearly the 200 microgram

is the way forward where it has the highest separation

in clinical clearance.

The histological clearance doesn't,

it does not have a very wide separation

but that's a regulatory factor.

The FDA will provide us guidance

that how much more histology clearance should be there

but from a clinician point of view, three out of four times

you see visual clearance, treated patients,

three out of four, don't need more,

that set the stage for what we believe

is a, is a blockbuster in the making.

Okay, and lastly, that FDA meeting will happen

imminently, right?

You like to get to get in to see them as soon as possible?

Yeah, we have begun the process.

We still need the CSR report to become available to us.

We feel before the end of the first half of this year,

at least we should have a request with the FDA

perhaps a meeting already scheduled

but if not in the first half,

certainly early second half of this year.

So June, July, we should be sitting with the FDA

but hopefully long before that,

we could have a strategic partner

that can co-develop this on a go forward basis.

Yeah, important decisions and work still to come for sure.

Dr. Bakari, thank you so much.

Really great update, great explanation as well

and appreciate your time.

Thank you so much, Steve, for having me back on your program.

All right, Dr. Razabakari, the CEO of Medicus Farma.