Richland, WA, Sept. 26, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (OTC PINK: RDGL) first therapy to canine treat soft tissue sarcoma is successful
Vivos Inc, a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, is pleased to report several significant outcomes after its signature product, IsoPet®, was used to treat a hind-leg soft-tissue sarcoma in a Sheltie at the University of Missouri Veterinary Health Center in Columbia, Missouri.
Veterinary oncologist, Dr. Charles Maitz, reported that the treatment of the sarcoma resulted in a “complete response,” meaning tumor destruction and disappearance, together with a healthy recovery. Results will be presented in at the Veterinary Cancer Society’s annual conference in Louisville, Kentucky, October 17 – 20, 2018.
After therapy the pet owner commented that the dog had more energy than she can remember for a long time. “The owner is delighted!” said Dr. Maitz.
Study investigators were also pleased that IsoPet® met all RadioGel™ design performance criteria. Post-treatment imaging and dosimetry provided confirmatory data addressing the principal questions previously raised by an FDA review panel, including:
- Near-uniform placement by injection and interstitial perfusion within the tumor without vascular clearance to normal organs and tissues
- Very high therapeutic ratios (radiation dose to the tumor relative to normal organs)
- Effective, highly localized, high-dose radiotherapy, and complete absence of adverse side-effects in critical normal tissues
The University of Missouri is now advertising availability of IsoPet® treatment for dogs and other species, including treatment of equine (horse) sarcoids.
Mike Korenko, Vivos Inc CEO stated “The successful treatment of the cat and dog subjects thus far increases the likelihood of IsoPet® becoming a practical solution in the treatment of animal cancer. Additionally, the data obtained at the University of Missouri will support the pre-clinical investigations required by the FDA to provide evidence that RadioGel™ can be safe and effective for treating various human cancers.”
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. has developed an yttrium-90-based brachytherapy injectable device for treating tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy employs highly localized minimally invasive radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel formulation. The injections deliver 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 RadioGelTM 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 continue.
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
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.
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CONTACT: Vivos Inc. Michael K. Korenko, President & CEO MKorenko@RadioGel.com
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