KENNEWICK, WA / ACCESSWIRE / February 28, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released the third letter in a four letter series outlining AMI's push towards FDA submittal and commercialization from its new President & CEO, Dr. Mike Korenko.
After two months of dynamic experience-based discussions among our Medical Advisory Board Members and other senior doctors we have selected our first indication for use which we will present to the Food and Drug Administration.
After thorough review to prioritize indications, we have selected basal cell and squamous cell carcinoma (skin cancers). The reasons for this important selection relates to our criteria below:
1. POTENTIAL FOR FDA APPROVAL AND SUCCESSFUL THERAPY:
a. Accessibility, ease of application:
This cancer is in the skin and therefore easy to access. Single injections for small tumors are easy and we have already demonstrated our parallel injection procedure in the cat at Washington State University for larger tumors.
b. Therapeutic ratio (ratio of the dose to the tumor target tissue relative to dose to adjacent normal tissue) and responsiveness to radiation:
Yttrium-90 is a beta emitter in RadioGel has a much higher therapeutic ratio than any gamma emitter or external beam therapy. Since Y-90 delivers high-energy beta-rays, it has an average penetration path of 4 to 5 mm (less than a quarter inch), which is ideal for skin cancer therapy. There is minimal irradiation of normal surrounding tissue. As an added bonus, the patent can go home immediately with no irradiation risk to themselves or family members.
We can treat with very high doses, so response to radiation would not be an issue. (As a comparison, external beam radiation can deliver 60 to 80 Gy. Yttrium-90 in RadioGel can go to 700 Gy or higher).
c. Potential collateral risks from injection:
As discussed above, there is very low risk of collateral damage. In addition, the skin is not located next to a major organ, for example if you were injecting near spinal tumors.
d. FDA Testing requirements:
Because of the low collateral risk and because of the therapeutic effects that would be relatively easy to see in three months, the Medical Advisory Board felt this might be an easier device for the FDA to approve and in a shorter timeframe. In addition, some of our animal testing, that will start in about two months, are already treating similar cancers.
We intentionally avoided applying to the FDA for melanoma, since it is highly metastatic and goes deep into the tissue. There are a much smaller number of cases for this cancer type (around 300,000). In addition, there are three new immunotherapy products on the market to treat melanoma cancer. They can have serious side-effects, but they are promising. That violates our next criterion below.
2. NOTABLE ADVANTAGE OVER CURRENT THERAPIES:
Some skin cancers require several-hour long surgeries in which the tumor is removed, one layer at a time, and then sent for biopsy. They then require a skin graft that can lead to an infection. On tumors of the face this can be disfiguring. As people get older their skin gets thinner, which increases the difficulty. Our Advisory Board felt that for these cases in particular RadioGel has a significant therapeutic advantage. It would be comparatively benefit the patient and contribute to reducing the cost of health care.
3. CAN BE PROFITABLY EMBRACED BY THE MEDICAL COMMUNITY:
a. Number of patients:
One out or every three new cancers in the United States is a cancerous skin lesion. The two skin cancer types that we selected are the most common. There are 3.3 million patients in the United States with 5.5 million tumors (some patients have more than one tumor.) About 1 million of these are squamous cell cancers located near the surface of the epidermal skin layer, and greater than 4 million are basal cell cancers in the deep layer of the epidermis. I would never say that we can treat them all; that would just be marketing hype, but I believe that this will be the preferred treatment in a substantial number of cases in a very large market.