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Title: Commercial Clinical Application of Boron Neutron Capture Therapy

Abstract

CRADA No. 95-CR-09 among the LITCO--now Bechtel BWXT Idaho, LLC; a private company, Neutron Therapies Limited Liability Company, NTL formerly Ionix Corporation; and Washington State University was established in 1996 to further the development of BNCT. NTL has established a laboratory for the synthesis, under US FDA approved current Good Manufacturing Practices (cGMP) guidelines, of key boron intermediates and final boron agents for BNCT. The company has focused initially on the development of the compound GB-10 (Na{sub 2}B{sub 10}H{sub 10}) as the first boron agent of interest. An Investigational New Drug (IND) application for GB-10 has been filed and approved by the FDA for a Phase I human biodistribution trial in patients with non-small cell lung cancer and glioblastoma multiforme at UW under the direction of Professor Keith Stelzer, Principal Investigator (PI). These trials are funded by NTL under a contract with the UW, Department of Radiation Oncology, and the initial phases are nearing completion. Initial results show that boron-10 concentrations on the order of 100 micrograms per gram (100 ppm) can be achieved and maintained in blood with no indication of toxicity.

Authors:
Publication Date:
Research Org.:
Idaho National Laboratory
Sponsoring Org.:
USDOE
OSTI Identifier:
942161
Report Number(s):
INL/CRADA-95-09
TRN: US0901322
DOE Contract Number:  
DE-AC07-05ID14517
Resource Type:
Technical Report
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; 72 PHYSICS OF ELEMENTARY PARTICLES AND FIELDS; BLOOD; BORON; BORON 10; GLIOMAS; LUNGS; MANUFACTURING; NEOPLASMS; NEUTRON CAPTURE THERAPY; NEUTRONS; PATIENTS; RADIATIONS; RECOMMENDATIONS; SYNTHESIS; TOXICITY; US FDA

Citation Formats

N /A. Commercial Clinical Application of Boron Neutron Capture Therapy. United States: N. p., 1999. Web. doi:10.2172/942161.
N /A. Commercial Clinical Application of Boron Neutron Capture Therapy. United States. doi:10.2172/942161.
N /A. Fri . "Commercial Clinical Application of Boron Neutron Capture Therapy". United States. doi:10.2172/942161. https://www.osti.gov/servlets/purl/942161.
@article{osti_942161,
title = {Commercial Clinical Application of Boron Neutron Capture Therapy},
author = {N /A},
abstractNote = {CRADA No. 95-CR-09 among the LITCO--now Bechtel BWXT Idaho, LLC; a private company, Neutron Therapies Limited Liability Company, NTL formerly Ionix Corporation; and Washington State University was established in 1996 to further the development of BNCT. NTL has established a laboratory for the synthesis, under US FDA approved current Good Manufacturing Practices (cGMP) guidelines, of key boron intermediates and final boron agents for BNCT. The company has focused initially on the development of the compound GB-10 (Na{sub 2}B{sub 10}H{sub 10}) as the first boron agent of interest. An Investigational New Drug (IND) application for GB-10 has been filed and approved by the FDA for a Phase I human biodistribution trial in patients with non-small cell lung cancer and glioblastoma multiforme at UW under the direction of Professor Keith Stelzer, Principal Investigator (PI). These trials are funded by NTL under a contract with the UW, Department of Radiation Oncology, and the initial phases are nearing completion. Initial results show that boron-10 concentrations on the order of 100 micrograms per gram (100 ppm) can be achieved and maintained in blood with no indication of toxicity.},
doi = {10.2172/942161},
journal = {},
number = ,
volume = ,
place = {United States},
year = {1999},
month = {9}
}