A New Way to Treat Skin Cancer... No Surgery Required??? Dr. Raza Bokhari, CEO and Chairman, Medicus Pharma Ltd.
Each year, over three million people in The U. S. Are diagnosed with non melanoma skin cancer. Over eight hundred thousand undergo what is called Mohs surgery, A new approach to treating this cancer and going further, avoiding Mohs surgery, is in ongoing phase two studies in both The US and Europe. Doctor.
Dr. Moira Gunn:Raza Bokhari is the CEO of Medicus Pharma. I want to start here with what has been described to me as the most common kind of skin cancer, basal cell carcinoma. What is it? How many people get it? How serious is it?
Dr. Raza Bokhari:Non melanoma skin diseases represent the most common ailments of the skin. Basal cell carcinoma amongst those is the most commonest of all, with five million new cases emerging just in The United States. It is a form of cancer, which is wherever there is ultraviolet radiation or exposure to sunlight and fair skinned population, that is the breeding ground for this type of cancer. The good news is that it is a slow growing cancer and with an effective treatment, it does not cause any morbidity or mortality. And in Western Hemisphere, there is a surgical intervention which is considered a definitive treatment where the cancer is curettaged and removed and is treated quite effectively, but painfully, expensively, and aesthetically not in a very pleasing fashion.
Dr. Moira Gunn:And are you talking about the so called Mohs surgery? M O H, Mohs surgery?
Dr. Raza Bokhari:That is correct. Mohs surgery is a modified surgical procedure in the hands of trained dermatologists with subspecialty certification, which there are about, 5,000 or so in The United States that carry out these Mohs procedures, which add up to about 1,000,000 or so procedures every year.
Dr. Moira Gunn:Now, as I understand it, there are also topical medications, right?
Dr. Raza Bokhari:There is an approved topical application. Active compound is five thioflourourocell, but these applications, these topical applications are more therapeutic for a superficial type of basal cell carcinoma, which is the smaller subset. The five million new cases that emerge every year, sixty percent to seventy percent are the nodular type of basal cell carcinoma, followed by a superficial type, which represent twenty percent to twenty five percent. These topical applications have demonstrated efficacy in the superficial type, their outcome of treatment in the nodular type is not very promising.
Dr. Moira Gunn:Now, let me ask you this, if you can get that topical into those nodules, is it effective or are those a different kind of a cancer?
Dr. Raza Bokhari:So the topical application, the active compound, of five theofluorouracil, perhaps if it will find its way into the interstitial fluid transdermally, perhaps would result in a therapeutic positive outcome. But when you apply it and rub it onto the skin, it does not go past the subcutaneous tissue of the fatty layer beyond the skin, below the skin.
Dr. Moira Gunn:Well, now we get to Medicus Pharma, and you're definitely trying to get below that superficial layer. What are you doing?
Dr. Raza Bokhari:By delivering a known chemotherapeutic agent called Doxyrubicin. And we delivered this transdermally by tip loading this on micro needle arrays and apply the patch at the site of the lesion. And as it penetrates the dermis and touches the interstitial fluid, these needles dissolve and deliver Doxyrubicin at the site of the lesion and through an immunogenic response cause cell death or cell apoptosis.
Dr. Moira Gunn:Now sticking with this patch, what we're talking about, first of all, is the patch itself has these tiny needles that once they go so you can you can get all over that skin area and in insert the needles down, but then the needles dissolve.
Dr. Raza Bokhari:These tiny micro needle arrays, seven fifty micron in size, 400 of these assembled in a patch, which is not more than 15 by 15 millimeter is tip loaded with Doxy Rubicon and these needles penetrate the skin and when they enter the interstitial fluid, they dissolve and initiate an immunogenic response and cause cell death.
Dr. Moira Gunn:Now let me ask you, this is a different drug than we were talking about when you talked about a topical coverage,
Dr. Raza Bokhari:That is correct. The topical application which is approved is five thioflourouacil. It is also a chemotherapeutic agent, but a different chemical composition. Toxorubicin is a very potent cell killer. It has been around for forty plus years.
Dr. Raza Bokhari:It is called a it's a killer. It kills. It does not discriminate. Whenever it enters into any cells, healthy cells, cancerous cells, it kills. It is so bad that, when I was graduating from medical school many, many moons ago, we would all read about Doxyrubicin and the toxic side effects that would cause red death.
Dr. Raza Bokhari:So it is very potent cardiotoxic agent while it kills the cancer cells, but it also causes serious adverse side effects. So mostly, this compound has been benched and is seldom used, for active treatment in modern medicine.
Dr. Moira Gunn:So why can you use it here?
Dr. Raza Bokhari:We are microdosing. We are using this drug, this very potent drug in microns, in 100 and in two hundred micrograms. So these are micro doses which are through these uniquely designed needle are being delivered directly to the site of the lesion without entering the bloodstream. And the company in its phase one safety and tolerability study, we delivered Doxyrubicin at the site of the lesion without any serious, systemic or local adverse effects. And so this uniquely designed needle did the job by not only delivering the medication, realising the potency and efficacy without any adverse effects, which is what we believe is a breakthrough technology.
Dr. Moira Gunn:Now, do you determine that the cancer is really gone in these studies?
Dr. Raza Bokhari:That's a very important question. In the clinical trial, when we apply this patch in three office, in an office setting, in three thirty minute sitting one week apart, we call the patient back for visual inspection. And at that time, when we see that the lesion has cleared, which in more than sixty percent of the patients, it does demonstrate that it has cleared, we do an excisional biopsy. So we cut out the area where the cancer was, excise it, and do an histological examination to confirm that there are no cancer cells left. Post approval, there will be no need to do that excision to confirm histological findings.
Dr. Raza Bokhari:But in the trial, that is how we confirm that what is visually has shown that the cancer cells have been cured. This is also confirmed through this histological examination.
Dr. Moira Gunn:Doctor. Raza Bokhari is the CEO of Medicus Pharma. More information on how to participate in the ongoing phase two study in both The U. S. And in Europe is available at medicuspharma.com.
