Next-Generation Cancer Treatment For Humans

Precison Radionuclide Therapy™

Also known as PRnT™, the treatment uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area, delivering therapeutic radiation from within the tumor. Vivos Inc. has developed a Yttrium-90 based injectable device to treat tumors in animals (IsoPet® Division) and humans (RadioGel® Division, not currently approved for human use).

Radionuclide therapy, also known as nuclear medicine therapy or radiopharmaceutical therapy, involves the use of radioactive substances to treat diseases, most commonly cancer. The therapy utilizes radionuclides, which are radioactive isotopes, attached to molecules that can specifically target cancer cells. This allows the radionuclides to deliver targeted radiation directly to the tumor or diseased area, minimizing damage to surrounding healthy tissue.

In this treatment, the radioactive isotopes emit radiation that damages the DNA of the targeted cells, leading to cell death or a significant reduction in the cell's ability to multiply. The most familiar forms of radionuclide therapy include treatments for thyroid cancer using iodine-131, pain relief from bone metastases with strontium-89 or samarium-153, and peptide receptor radionuclide therapy (PRRT) for treating neuroendocrine tumors using radionuclide peptides. Vivos Inc. and their patented Precision Radionuclide Therapy™ uses Yttrium-90 to kill tumors and is revolutionizing the treatment of cancer.

RadioGel® is currently not approved for human therapy by the FDA. Human trials are taking place in India.

The product comprises highly insoluble, microscopic, (nominally < 2.0 µm diameter), yttrium-90 phosphate, (90YPO4), crystalline particles suspended in a sterile phosphate-buffered saline-polymer delivery vehicle, (hydrogel), that is liquid at room temperature. The Y-90 RadioGel®/Hydrogel mixture is injected directly and uniformly into tumors. The Y-90 RadioGel® perfuses tumor tissue via interstitial fluid spaces to distribute the microscopic Y-90 particles evenly throughout the tumor tissue. The product gels in place as the delivery vehicle approaches body temperature within the interstitial spaces, (within approximately 15 - 30 seconds). The gelation solidifies the product in place and inhibits migration of the insoluble 90YPO4 particles away from the placement site.  This sequestering of the insoluble 90YPO4 particles precludes their re-distribution to other parts of the body. Direct placement of the product within the tumor maximizes the radiation dose to the target and minimizes radiation exposure to other organs and tissues, thereby achieving a high therapeutic index. The negligible non-target radiation is expected to have no discernible side effects. Test data show no significant migration of 90YPO4 beyond the treatment zone.

Y-90 RadioGel® employs the high energy (2.3 MeV maximum), short-path length (11 mm maximum), pure beta-particle-emitting radionuclide yttrium-90 (physical half-life of 2.67 days), which effectively delivers a pre-determined highly localized radiation absorbed dose to the target tumor. The average Y-90 beta particle path length of 4.7 mm optimizes the local delivery of therapeutic radiation to cancerous tissue while effectively minimizing radiation dose to nearby healthy tissues. The Y-90 (90YPO4) particles within the Y-90 RadioGel® are highly insoluble to effectively preclude Y-90 release from the particles by dissolution in body fluids. The hydrogel delivery vehicle for the Y-90 particles comprises an injectable, sterile, phosphate-buffered saline solution containing a dissolved co-polymer of PLGA, (poly-DL-lactic acid-co-glycolic acid), and PEG, (poly-ethylene glycol), referred to as PLGA-g-PEG. The sequence of PLGA and PEG separated by the “g” is a standard notation that indicates that the primarily hydrophobic PLGA forms the backbone of the polymer with the hydrophilic polyethylene glycol component grafted onto the backbone.

Y-90 RadioGel® may be implanted using hollow needles (e.g. 22 – 25 gauge).  Y-90 RadioGel® is supplied sterile and is intended for single (one-time) patient use.

Principle Radionuclide:  Yttrium-90 (Y-90)

Half-life of Y-90:                     2.67 Days

Radiation Energy:                β-emitting, 2.3 MeV maximum