ANALYSIS OF NA2B12H11SH FOR NEUTRON CAPTURE THERAPY

NUCLEAR MEDICINE, INC. (NMI) INTENDS TO COMMERCIALIZE AN ALTERNATE FORM OF RADIATION THERAPY KNOWN AS BORON NEUTRON CAPTURE THERAPY (BNCT). THIS THERAPY IS CURRENTLY AND SUCCESSFULLY BEING USED IN JAPAN TO TREAT BRAIN TUMORS. THEFOOD AND DRUG ADMINISTRATION REQUIRES CHEMICAL CHARACTERIZATION OF NA2B12H11SH, THE PHARMACEUTICAL THAT MAKES THE THERAPY POSSIBLE, BEFORE IT WILL APPROVE CLINICAL TRIALS FOR BNCT IN THE UNITED STATES. NMI HAS OBTAINED ORPHAN DRUG STATUS FOR NA2B12H11SH AND PROPOSES TWO DIFFERENT QUANTITATIVE METHODS FOR MEASURING ITS PURITY: TRACK-ETCH/THIN-LAYER CHROMATOGRAPHY (TLC) AND HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC). THE FORMER METHOD ALLOWS THE SENSITIVE MEASUREMENT OF THE (10)B ISOTOPEIN THE BORON POLYHEDRON. MEASUREMENT BY HPLC IS BASED ON ANALYSIS OF THE SULFHYDRYL GROUP ON B12H11SH(2)- BY ELECTRO-CHEMICAL OR OTHER MEANS. THE TECHNIQUES THUS COMPLEMENT ONE ANOTHER AND CAN BE SYMBIOTICALLY APPLIED TO BOTH CHEMICAL AND BIOCHEMICAL ANALYSIS OF BORON-CARRIER COMPOUNDS.