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Friday, January 04, 2019 4:47:16 PM
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.”
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