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Wednesday, April 17, 2019 4:51:59 PM
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 an 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.”
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