EPITHERMAL NEUTRON-BEAM APPROACH TO NEUTRON CAPTURE THERAPY

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 7175
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1987
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Theragenics Corp
900 Altantic Dr Northwest, Atlanta, GA, 30318
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JOHN L RUSSELL JR PHD
 (404) 873-6309
Business Contact
Phone: () -
Research Institution
N/A
Abstract
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.

* information listed above is at the time of submission.

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