Next-Generation Cancer Treatment For Humans

Y-90 RadioGel® is a device designed for radiation treatment of solid tumors. 

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