EPITHERMAL NEUTRON-BEAM APPROACH TO NEUTRON CAPTURE THERAPY

THERAGENICS CORPORATION HAS DEVELOPED THE FIRST FILTER DEVICE TO GENERATE A DEEPLY PENETRATING, HIGH-FLUX, EPITHERMAL NEUTRON BEAM FREE OF SIGNIFICANT FAST NEUTRON CONTAMINATION. THE DEVICE IS A PROTOTYPE OF A THERAPEUTIC VERSION INTENDED FOR USE IN AN ALTERNATIVE FORM OF RADIATION THERAPY KNOWN AS BORON NEUTRON CAPTURE THERAPY (BNCT). THE EPITHERMAL NEUTRON BEAM WILL ULTIMATELY BE COUPLED WITH A THERAGENICS CORPORATION ORPHAN DRUG, NA2 (10)B12H11SH, FORTHE TREATMENT OF THE EXTREMELY MALIGNANT BRAIN TUMOR, GLIOBLASTOMA MULTIFORME. UPON FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL OF BOTH THE DRUG AND DEVICE, RADIATION SERVICES WILL BE OFFERED THAT ARE MUCH LIKE THOSE IN RADIATION THERAPY AND ONCOLOGY DEPARTMENTS IN MAJOR HOSPITALS. PHASE I CONSISTS OF REBUILDING AND OPTIMIZING THE PROTOTYPE DEVICE FOR THERAPEUTIC PURPOSES. PHASE II INVOLVES EXTENSIVE CHARACTERIZATION OF THE RESULTANT EPITHERMAL NEUTRON BEAM, FULFILLING FDA REQUIREMENTS FOR AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) APPLICATION. PHASE II WILL THEN CONTINUE WITH TWO ANIMAL STUDIES TO ASSESS THE SAFETY OF THE GLIOBLASTOMA TREATMENT. THE RESULTS OF THESE STUDIES WILL FINALIZE PROTOCOLS FOR CLINICAL TRIALS OF EPITHERMAL NEUTRON BEAM BNCT.