Richland WA, Feb. 25, 2019 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL)
Vivos Inc. (OTCPINK: RDGL), a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in animals and humans, provides this update on the dogs that were treated to date in the canine soft tissue sarcoma series.
IsoPet therapy is applied in a single therapy session. Most of the radiation dose is delivered within the first ten days as the Yttrium-90 decays. It then takes several months for the dead tumor to be absorbed by the animal. In general, sarcomas tend to be resistant to radiation and slow to respond to therapy but also prone to recurrence, so continued monitoring of these patients and future patients is critical.
Dog 1 was treated in May 2018. He had acute radiation side effects compounded by self-trauma (biting and scratching the tumor site), but achieved a CR (complete response) per the response evaluation criteria in solid tumors (RECIST) criteria and the normal tissues associated with the irradiation site appeared healthy. The patient was re-evaluated in February 2019 which included a CT scan. While the original tumor was destroyed, a recurrent tumor appeared which has been observed for sarcomas treated with other modalities including surgery and external beam radiation therapy (EBRT). Fortunately, the skin overlying the new tumor looks healthy and second therapy will be scheduled imminently.
Dog 2 which was treated in July 2018 and his results are encouraging. This patient had transient mild acute radiation side effects, and had SD (stable disease) at the time of recheck. There was a small amount of growth, but not enough to be considered progression per the RECIST criteria. The CT on his last visit showed that the tumor site had a slightly larger but diffuse image.
Based on this single observation, the diffuse image could mean that the hydrogel, in addition to trapping the particles, provides a secondary benefit of locking in the dead tumor tissue allowing for a slower rate of resorption of the necrotic tissue. This could be a positive outcome whereas killing a tumor and having it resorb within the tissue all at once might be a shock to the animal’s system. We will continue to monitor how this case proceeds.
Dog 3 was treated in January 2019. This very large, half-pound, tumor was initially scheduled for therapy in December but had to be rescheduled since the hydrogel did not meet our rigid specifications. From this, we learned that frozen hydrogel has a limited shelf life and this allowed us to make the appropriate adjustments to our product specifications.
This patient had mild to moderate acute radiation side effects and has SD (stable disease) one-month post treatment. The February follow-up included a CT scan. The mass showed no new growth and measures almost the same as it did at the time of treatment. There is a small region at the bottom of the tumor where the mass seems to be draining. The tumor around the highest dose region appears dead with no blood supply, according to the CT.
Dog 4 - We treated another animal for canine soft tissue sarcoma on February 21 and are awaiting a follow-up appointment for examination of the dog
Dr. Mike Korenko, Vivos Inc CEO stated “IsoPet® is behaving as designed and the treatments applied thus far prove that it kills cancerous tumors. IsoPet® is minimally invasive compared to repeated surgeries, greatly spares normal tissue, and can achieve significantly higher dose than other therapies thereby increasing the probability of eradicating the disease. We will continue to generate new data via additional therapies at the University of Missouri. Following the canine soft tissue series, we plan to begin therapy of equine sarcoids, which are common in horses, but have limited options for effective treatment. Results of ongoing studies will be presented at premier scientific events such as the Veterinary Cancer Society annual meeting.”
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 the University of Missouri is currently underway.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. 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 premarket 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.
Michael K. Korenko, President & CEO