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Dasatinib treatment for Philadelphia chromosome-positive leukemias : Practical considerations
Khoury, Hanna Jean,Guilhot, Franç,ois,Hughes, Timothy P.,Kim, Dong-Wook,Cortes, Jorge E. Wiley Subscription Services, Inc., A Wiley Company 2009 Cancer Vol.115 No.7
<P>Dasatinib is a highly potent Bcr-Abl inhibitor that is approved for the treatment of imatinib-resistant or -intolerant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. Across a series of phase 2 and 3 trials, dasatinib was associated with durable treatment responses in all phases of the disease and was well tolerated. For this article, the authors reviewed available information on specific side effects associated with the use of dasatinib. On the basis of more than 2 years' experience of dasatinib treatment during clinical trials, they provide practical recommendations for side-effect management. Cancer 2009. © 2009 American Cancer Society.</P>
Delaney, Bryan,Zhang, John,Carlson, Gabrielle,Schmidt, Jean,Stagg, Barb,Comstock, Brad,Babb, Amy,Finlay, Carol,Cressman, Robert F.,Ladics, Greg,Cogburn, Amarin,Siehl, Dan,Bardina, Luda,Sampson, Hugh,H Oxford University Press 2008 Toxicological sciences Vol.102 No.2
<P>The glyphosate acetyltransferase (gat) gene from Bacillus licheniformis was subjected to multiple rounds of gene shuffling to optimize kinetics of corresponding GAT proteins to acetylate the herbicide active ingredient glyphosate. Genetically modified soybeans expressing the gat4601 gene (356043 soybeans) are tolerant to the application of glyphosate. The current manuscript reports the outcome of the allergenicity and toxicity assessment for the GAT4601 protein. Bioinformatic comparison of the amino acid sequence of GAT4601 did not identify similarities to known allergenic or toxic proteins. In vitro studies conducted with heterologously produced GAT4601 protein demonstrated that it was rapidly degraded in simulated gastric fluid containing pepsin (< 30 s) and in simulated intestinal fluid containing pancreatin (< 2 min) and completely inactivated at temperatures above 56 degrees C. The GAT4601 protein expressed in planta is not glycosylated and similar protein profiles were observed in flour extracts from 356043 soybeans and nontransgenic near isoline comparator soybeans (Jack) using serum from soy allergic persons. No evidence of adverse effects was observed in mice following acute oral exposure to 2000 mg/kg of GAT4601 protein or in a repeated dose dietary exposure study at doses of 800-1000 mg/kg/day. This comprehensive assessment demonstrates that the GAT4601 protein does not present a risk for adverse effects in humans when used in the context of agricultural biotechnology.</P>