Basal cell carcinoma and squamous cell carcinoma (skin cancers) selected, representing over 5,500,000 diagnoses annually in the US alone, making it the most prevalent cancer today
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.
Dear Shareholders,
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 patient 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 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 of 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.
b. Ease of acceptance by the medical community, Medicare reimbursement:
The potential lower cost of RadioGel therapy coupled with the potential very large number of patients satisfied this criterion. To further test the criterion, we are in discussions with a major private clinic with several skin treatment centers. This client believes this is a great new tool for their toolbox. They are also advising us on the obstacles that will have to be overcome, such as our Medicare reimbursement criterion. Since we believe RadioGel therapy will reduce the cost to Medicare we are confident that will not be an obstacle.
There are other cancer types on our list of eighteen potential indications of use for RadioGel, and we have already prioritized to present them to the FDA in the future. Unfortunately, in the meantime, those patients will not be benefiting from this technology.
As I have reported in my last shareholder letter, I am aligning the veterinarian animal testing with the human skin cancer. Specially, the University of Missouri will be focusing on the treatment for surface soft cell lesions, and Colorado State University will be refining the therapies for oral squamous cell cancers.
After this selection, our next step is to prepare for the FDA pre-submittal meeting. We will request that meeting after we complete the test plans that will answer their previous questions. Until we complete these plans I can only estimate that our pre-submission to the FDA would be in June. I am really happy that we have engaged John Smith from Hogan Lovells to be at our side through this FDA process.
I am excited and relieved that this selection decision had been made and I wanted to thank the members of our Medical Advisory Board – Chairman Dr. Barry D. Pressman, Dr. Albert DeNittis, Dr. Howard Sandler, and Dr. Darrell Fisher. I would also like to thank Dr. Ricardo Paz-Fumagalli and Dr. Beau Bosko Toskich from the Mayo Clinic for their valuable advice.
In addition to the important developments discussed above, we continue to believe that the public markets are significantly undervaluing our company. With a fully diluted enterprise value of less than $10 million, there remains very large upside potential. As we progress on our plan, I intend to work vigorously to educate and inform the medical and investment community as to the therapeutic benefits our core technology as well as the economic model that can generate significant revenue and profits. We are committed to pursuing an uplisting to a national exchange as soon as possible in order to gain wider exposure and credibility in our pursuit of the multi-billion-dollar addressable market for Radiogel™, that can both significantly improve patient outcomes and reward shareholders.
Dr. Mike Korenko
President and CEO (acting), Advanced Medical Isotope and IsoPet
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Company Contact:
Advanced Medical Isotope
Dr. Mike Korenko, President & CEO
Investors:
Circadian Group IR
Tyler Troup, B. Comm
[email protected]
866-950-8300
SOURCE: Advanced Medical Isotope Corporation