Commercial Launch Begins at 4 University Hospital "Centers of Excellence" with the Data Generated to be Used as a Springboard to FDA Submission for Human Use
KENNEWICK, WA / ACCESSWIRE / March 7, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGelTM device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released the fourth 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,
In my February letters, I described our progress in the medical sector. With this letter, I will discuss the veterinary sector.
In my January 11th letter, I discussed my intent to evaluate four major veterinary teaching hospitals to confirm veterinarian interest and to select the best places to introduce RadioGelTM for treating cancer in animals. Since then, I have visited three centers and have had discussions with a fourth. I am encouraged that four of the country's best veterinary medical centers have now independently reviewed the RadioGelTM device as a therapy and have agreed it would be an exciting new tool in their cancer-treatment toolbox. Each center is an impressive and respected teaching hospital, and each is anxious to use RadioGelTM as a cancer treatment. Therefore, I have decided to move forward on four fronts.
Each veterinary center of excellence will focus on a different cancer type:
- Washington State University - feline sarcoma, possibly followed by canine sarcoma (Dr. Janean Fidel and Dr. Megan Duffy)
- University of Missouri - soft tissue carcinoma, followed by localized prostate cancer (Dr. Jimmy Lattimer and Dr. Jeffrey Bryan)
- University of Florida - lymph nodes, followed by liver cancer (Dr. Beau Toskich, Dr. Brad Case and Dr. Sarah Boston)
- Colorado State University - oral squamous cancer (Dr. Jac Nickloff and Dr. Susan LaRue)
These tumors in animals serve as models for a variety of related human cancers. Clear demonstration of therapeutic benefits in animals would directly enhance our pending FDA application for human use.
Together, with Dr. Alice Villalobos, Chair of our Veterinary Medicine Advisory Board, the specialists listed above are accomplished leaders in U.S. veterinary oncology. Their engagement will provide significant support to our plans to introduce RadioGelTM throughout the entire field, including private veterinarian clinics. As academics, these specialists are motivated to publish their work with RadioGelTM in peer-reviewed scientific literature. Scientific and medical journal articles would help to advance the use of RadioGelTM as a treatment of choice.
Pre-clinical studies have already begun at Washington State University. The others will begin by preparing animal welfare and research protocols. Our medical physicist, Dr. Darrell Fisher, past president of the Health Physics Society, will address any questions from review committees on radiation safety and the characteristics of RadioGelTM for the treatment of cancer.
Each of the selected veterinary centers will optimize a treatment approach, which we will incorporate into an FDA approved Label format. We will then ask the FDA to review these Labels, as recommended by their guidance. These Labels, together with clinical research experience, will then be used as a part of our supporting data for our medical application to the FDA.
The Labels and clinical experience will translate to use by veterinarians in smaller, private clinics. Dr. Villalobos believes that her private clinic could be the first to capitalize on this broad-based experience and she is reviewing this with the facility owners. This schedule will give her ample time to put into place the required radioactive material license. We will work with her to expedite that application.
Since the FDA has classified RadioGelTM as a medical device, rather than a drug product, we can more easily implement any future improvements in the product design and the application techniques to benefit the animals and to strengthen our intellectual property, without requiring additional FDA approvals.
Next month, we will begin interviewing candidates for a veterinary oncologist to head the IsoPet subsidiary.
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.
CONTACTS:
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