Richland, WA, Dec. 04, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL) a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, has agreed to supply IsoPet® to treat a dog with advanced cancer at the University of Missouri. The procedure is scheduled to take place on December 6, 2018. The animal has a large tumor that weighs approximately one-half pound, which is well outside the parameters of our study plan for treatment of canine sarcomas. In addition, the patient has a growth in one lung indicating the cancer may have metastasized.
The dog’s owner was passionate about obtaining the treatment. We ultimately agreed on humanitarian grounds that the potential benefits of treatment with IsoPet® would outweigh the risks, even though the patient is likely to eventually succumb to metastatic disease. It will be the largest tumor treated with IsoPet to date, and offers the opportunity to evaluate the practical aspects of treating large tumors and help determine the parameters of effectiveness of the therapy. Additionally, there is evidence that a dying tumor can stimulate an animal’s immune system to recognize and destroy the cancerous cells, providing some encouragement for an outside chance that the metastatic cancer cells could be attacked well outside the tumor boundary. Effectively then, this treatment is being provided both for the hopeful benefit of the dog, as well as research.
Dr. Mike Korenko, Vivos Inc CEO stated “We deliberated carefully prior to making this decision since losing an animal, as is likely the case here, can draw substantial scrutiny by the FDA. We are being careful to identify this case as being outside the study plan criteria. In the end, the humanitarian aspect was the overriding factor in making this determination. A secondary benefit is the potential to learn from this therapy. We are confident that IsoPet® will be effective in treating the primary tumor, but there are uncertainties on how the patient’s system will react to a large necrosis volume and whether a synergistic effect against the metastatic disease will in fact be observed.”
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. is a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable device, for the treatment of tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel formulation. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
IsoPet® is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to the family.
The IsoPet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on canine soft tissue sarcomas at University of Missouri will begin in the near future.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device for skin cancer therapy in cats and dogs. The FDA also reviewed and approved the product labeling. FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGel™ for the treatment of advanced basal and squamous cell skin cancers in humans.
Safe Harbor Statement
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Michael K. Korenko, President & CEO