Richland, WA, May 31, 2018. Vivos Inc (OTC: RDGL) successfully treated canine soft tissue sarcoma with its proprietary IsoPet™ (RadioGel™), a
hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor.
A veterinary cancer specialist at the University of Missouri—Columbia successfully treated a soft-tissue tumor in the hind thigh of a Sheltie. Soft tissue sarcoma is a
relatively common tumor in dogs. The treatment procedure demonstrated ability to place yttrium-90 uniformly in the tumor for precision high-dose radiation therapy. The status of the
dog patient will be followed over the next six months as we evaluate safety and efficacy of yttrium-90-RadioGel treatment.
Immediately after treatment, the Sheltie was imaged using the University’s new state-of-the-art, high-resolution Celesteion positron-emission tomography/x-ray
computed tomography (PET/CT) imaging system, which enables clinicians to evaluate the surgical placement of RadioGel™. Medical imaging showed highly uniform placement
of RadioGel™ within the tumor boundaries without significant vascular migration of yttrium-90 to any nearby normal organ or tissue.
This treatment and imaging study provides important validation of RadioGel™ design properties and directly addresses U.S. Food and Drug Administration questions
concerning behavior of RadioGel™ within the tumor.
In technical terms, RadioGel™ in the tumor was imaged by virtue of x-ray contrast density provided by the
ingredient yttrium phosphate, which was clearly imaged by computed tomography (CT).
The uniform biodistribution of yttrium-90 was confirmed by positron-emission tomography, which maps the origin of radioactive decays from individual Y-90 atoms
distributed within the tissues. The images showed a uniformly distributed radiation source in the tumor.
Ability to deliver a very high-dose therapeutic radiation to non-surgically-resectable tumors without significant dose to normal tissues provides a key advantage
over conventional external beam therapy.
Mike Korenko, Vivos CEO, said, “The treatment went exceedingly
well. We delivered a very high dose to the tumor with negligible radiation to the surrounding healthy tissues, and the post-administration medical imaging confirmed uniform placement.
The inherent safety of a pure beta-emitting medical isotope, such as yttrium-90, translates directly to low radiation doses to the treating physician. We believe that this treatment
represents a major step toward commercialization of IsoPet for animal therapy. We designed this test series with a dual purpose as part of the testing that the FDA requires before we begin
clinical trials for treating cancer in humans. The success of this test is an important milestone in that process.”
We anticipate treating another five or more canine subjects in the current test series. With this continuing series of treatments, we will further refine our
product labeling and the training that will be provided to veterinarians that want to use our product in the future. We will also be sharing these data as we continue discussions with
private veterinary clinic consortium's.