Vivos Inc (RDGL)

[RobbinGood]

$RDGL excerpt "treating cancer in humans" "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."

$RDGL 05/31/18 Vivos Inc Successfully Treats Canine Sarcoma with IsoPet™ (RadioGel™)
GlobeNewswire•May 31, 2018

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Richland, WA, May 31, 2018 (GLOBE NEWSWIRE) -- Vivos Inc (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 consortiums.

Photos taken during the first canine treatment are posted on our website: www.RadioGel.com.

About Vivos Inc. (RDGL)

Currently, the Company has developed an Yttrium-90 based brachytherapy device, for the treatment of tumors in animals and humans. Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The product 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.

IsoPetTM 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.

IsoPetTM 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.