Timed-bioresorbable microspheres are being investigated as a vehicle for delivery of radioisotopes, particularly, Y-90 for localized radiotherapy. Microspheres of several calcium phosphate glasses prepared in Phase I have been shown to retain 99.0 to 99.9% of yttrium in vitro. They are non-toxic and bioresorbable. These microspheres must maintain similar structural integrity and yttrium release characteristics in vivo before they are clinically useful, since leakage of radioactivity from injection site reduces therapeutic efficacy, induces undesirable damage to normal tissues, and increases the risk of side effects and secondary neoplasia. Characterizing the release of Y-90 in vivo and identifying the relationship between in vitro and in vivo bioresorption rates will provide valuable input for glass composition optimization, and will set the criteria for bioresorption control through nano-scale chemistry. A team of distinguished collaborators gas been formed to lead in the safety and efficacy evaluations of using timed- bioresorbable Y-90 microspheres for treating solid tumors, arthritic joints, etc. Animal experiments are designed to address a variety of safety issues and adequate efficacy studies are also proposed. XL Sci-Tech expects to produce pilot quantities of timed-bioresorbable Y-90 microspheres that are safe for clinical investigations by the conclusion of the Phase II study.

Proposed Commercial Applications

Timed-bioresorbable Y-90 microspheres will deliver highly localized beta radiation without risk of activity leakage. These microspheres are ideal for direct intratumoral injection in treatment of cancers of liver, pancreas, etc., and radiation synovectomy of rheumatoid arthritis.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44CA076860-02
Application #
2790251
Study Section
Special Emphasis Panel (ZRG2-SSS-1 (02))
Program Officer
Stone, Helen B
Project Start
1997-09-30
Project End
2001-02-28
Budget Start
1999-03-03
Budget End
2000-02-29
Support Year
2
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Xl Sci-Tech, Inc.
Department
Type
DUNS #
931933824
City
Richland
State
WA
Country
United States
Zip Code
99354