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Burczynski M.E., and Dorner A.J. Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies. Pharmacogenomics 7 (2006) 187-202
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Liew C.-C., Ma J., Tang H.-C., Zheng R., and Dempsey A.A. The peripheral blood transcriptome dynamically reflects system wide biology: a potential diagnostic tool. J Lab Clin Med 147 (2006) 126-132
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Li L., Ying L., Naesens M., Xiao W., Sigdel T., Hsieh S., Martin J., Chen R., Liu K., Mindrinos M., et al. Interference of globin genes with biomarker discovery for allograft rejection in peripheral blood samples. Physiol Genomics 32 (2008) 190-197
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The antitumor agent imexon activates antioxidant gene expression: evidence for an oxidative stress response
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Baker A.F., Landowski T., Dorr R., Tate W.R., Gard J.M.C., Tavenner B.E., Dragovich T., Coon A., and Powis G. The antitumor agent imexon activates antioxidant gene expression: evidence for an oxidative stress response. Clin Cancer Res 13 (2007) 3388-3394
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Identification of short-term pharmacodynamic effects of interferon-beta-1a in multiple sclerosis subjects with broad-based phenotypic profiling
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Kantor A.B., Deng J., Waubant E., Lin H., Becker C.H., Lacy J.R., Perrone A.M., Bennett D., and Goelz S.E. Identification of short-term pharmacodynamic effects of interferon-beta-1a in multiple sclerosis subjects with broad-based phenotypic profiling. J Neuroimmunol 188 (2007) 103-116
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Two recombinant human interferon-beta 1a pharmaceutical preparations produce a similar transcriptional response determined using whole genome microarray analysis
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Prync A., Yankilevich P., Barrero P., Bello R., Marangunich L., Vidal A., Criscuolo M., Benasayag L., Famulari A., Domínguez R., et al. Two recombinant human interferon-beta 1a pharmaceutical preparations produce a similar transcriptional response determined using whole genome microarray analysis. Int J Clin Pharmacol Ther 46 (2008) 64-71
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Criscuolo, M.7
Benasayag, L.8
Famulari, A.9
Domínguez, R.10
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8
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33846864685
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Selective abrogation of Th1 response by STA-5326, a potent IL-12/IL-23 inhibitor
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Wada Y., Lu R., Zhou D., Chu J., Przewloka T., Zhang S., Li L., Wu Y., Qin J., Balasubramanyam V., et al. Selective abrogation of Th1 response by STA-5326, a potent IL-12/IL-23 inhibitor. Blood 109 (2007) 1156-1164
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Wada, Y.1
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9
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Use of pharmacokinetic/pharmacodynamic biomarkers to support rational cancer drug development
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This review provides an excellent overview of need and processes for biomarkers in oncology drug development. It brings forward the type of plan needed for the validation of assays for clinical use.
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Sarker D., Pacey S., and Workman P. Use of pharmacokinetic/pharmacodynamic biomarkers to support rational cancer drug development. Biomark Med 1 (2007) 399-417. This review provides an excellent overview of need and processes for biomarkers in oncology drug development. It brings forward the type of plan needed for the validation of assays for clinical use.
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Sarker, D.1
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Genomic changes and gene expression profiles reveal that established glioma cell lines are poorly representative of primary human gliomas
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Through SNP analysis and transcriptional profiling, chromosomal alterations, and differences in expression patterns indicative of altered biological pathways were detected between primary human gliomas and glioma cell lines. This study adds to the weight of evidence that cancer cell lines may not be relevant models for tumor biology.
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Li A., Walling J., Kotliarov Y., Center A., Steed M.E., Ahn S.J., Rosenblum M., Mikkelsen T., Zenklusen J.C., and Fine H.A. Genomic changes and gene expression profiles reveal that established glioma cell lines are poorly representative of primary human gliomas. Mol Cancer Res 6 (2008) 21-30. Through SNP analysis and transcriptional profiling, chromosomal alterations, and differences in expression patterns indicative of altered biological pathways were detected between primary human gliomas and glioma cell lines. This study adds to the weight of evidence that cancer cell lines may not be relevant models for tumor biology.
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Mol Cancer Res
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Li, A.1
Walling, J.2
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Rosenblum, M.7
Mikkelsen, T.8
Zenklusen, J.C.9
Fine, H.A.10
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11
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Short term culture of breast cancer tissues to study the activity of the anticancer drug taxol in an intact tumor environment
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van der Kuip H., Murdter T., Sonnenberg M., McClellan M., Gutzeit S., Gerteis A., Simon W., Fritz P., and Aulitzky W. Short term culture of breast cancer tissues to study the activity of the anticancer drug taxol in an intact tumor environment. BMC Cancer 6 (2006) 86
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Simon, W.7
Fritz, P.8
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12
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Efficacy of anti-death receptor 5 (DR5) antibody (TRA-8) against primary human ovarian carcinoma using a novel ex vivo tissue slice model
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Estes J.M., Oliver P.G., Straughn J., Michael J., Zhou T., Wang W., Grizzle W.E., Alvarez R.D., Stockard C.R., LoBuglio A.F., et al. Efficacy of anti-death receptor 5 (DR5) antibody (TRA-8) against primary human ovarian carcinoma using a novel ex vivo tissue slice model. Gynecol Oncol 105 (2007) 291-298
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LoBuglio, A.F.10
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13
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33947214077
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Chaetocin: a promising new antimyeloma agent with in vitro and in vivo activity mediated via imposition of oxidative stress
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This study shows the power of performing ex vivo testing of drug candidates on primary cancer cells to support clinical testing and understand mechanism of cytotoxic effects.
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Isham C.R., Tibodeau J.D., Jin W., Xu R., Timm M.M., and Bible K.C. Chaetocin: a promising new antimyeloma agent with in vitro and in vivo activity mediated via imposition of oxidative stress. Blood 109 (2007) 2579-2588. This study shows the power of performing ex vivo testing of drug candidates on primary cancer cells to support clinical testing and understand mechanism of cytotoxic effects.
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Blood
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Isham, C.R.1
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Jin, W.3
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Bible, K.C.6
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14
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44049100934
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Intrinsic resistance of tumorigenic breast cancer cells to chemotherapy
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Li X., Lewis M.T., Huang J., Gutierrez C., Osborne C.K., Wu M.-F., Hilsenbeck S.G., Pavlick A., Zhang X., Chamness G.C., et al. Intrinsic resistance of tumorigenic breast cancer cells to chemotherapy. J Natl Cancer Inst 100 (2008) 672-679
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Li, X.1
Lewis, M.T.2
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Wu, M.-F.6
Hilsenbeck, S.G.7
Pavlick, A.8
Zhang, X.9
Chamness, G.C.10
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15
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33750727368
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Genomic signatures to guide the use of chemotherapeutics
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Sophisticated transcriptional analysis identified regimen-specific gene expression signatures that predict tumor cell sensitivity to chemotherapeutics. Importantly, it includes validation with independent cell lines as well as published clinical data. This study suggests that while tumor cell lines are clearly biologically and genetically different than primary tumors, basic mechanisms may allow prediction of clinical responses and can be correlated to oncogenic pathways active in both cell culture and in vivo.
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Potti A., Dressman H.K., Bild A., Riedel R.F., Chan G., Sayer R., Cragun J., Cottrill H., Kelley M.J., Petersen R., et al. Genomic signatures to guide the use of chemotherapeutics. Nat Med 12 (2006) 1294-1300. Sophisticated transcriptional analysis identified regimen-specific gene expression signatures that predict tumor cell sensitivity to chemotherapeutics. Importantly, it includes validation with independent cell lines as well as published clinical data. This study suggests that while tumor cell lines are clearly biologically and genetically different than primary tumors, basic mechanisms may allow prediction of clinical responses and can be correlated to oncogenic pathways active in both cell culture and in vivo.
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Nat Med
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Potti, A.1
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Cragun, J.7
Cottrill, H.8
Kelley, M.J.9
Petersen, R.10
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16
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Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial
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An important study which shows that cancer cell line derived gene expression signatures can be applied to primary tumor expression signatures to accurately predict pateint response to therapy. Strikingly, single agent signatures could be combined to predict multiple agent therapeutic responses.
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Bonnefoi H., Potti A., Delorenzi M., Mauriac L., Campone M., Tubiana-Hulin M., Petit T., Rouanet P., Jassem J., Blot E., et al. Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol 8 (2007) 1071-1078. An important study which shows that cancer cell line derived gene expression signatures can be applied to primary tumor expression signatures to accurately predict pateint response to therapy. Strikingly, single agent signatures could be combined to predict multiple agent therapeutic responses.
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Lancet Oncol
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Bonnefoi, H.1
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Petit, T.7
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17
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Assessment of drug-induced liver injury in clinical practice
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Isabel Lucena M., Garcia-Cortes M., Cueto R., Lopez-Duran J., and Andrade R.J. Assessment of drug-induced liver injury in clinical practice. Fundam Clin Pharmacol 22 (2008) 141-158
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Fundam Clin Pharmacol
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18
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Turpeinen M., Ghiciuc C., Opritoui M., Tursas L., Pelkonen O., and Pasanen M. Predictive value of animal models for human cytochrome P450 (CYP)-mediated metabolism: a comparative study in vitro. Xenobiotica 37 (2007) 1367-1377
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Westerink W.M., and Schoonen W.G. Cytochrome P450 enzyme levels in HepG2 cells and cryopreserved primary human hepatocytes and their induction in HepG2 cells. Toxicol In Vitro 21 (2007) 1581-1591
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Westerink W.M., and Schoonen W.G. Phase II enzyme levels in HepG2 cells and cryopreserved primary human hepatocytes and their induction in HepG2 cells. Toxicol In Vitro 21 (2007) 1592-1602
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van Ravenzwaay B., Cunha G.C.-P., Leibold E., Looser R., Mellert W., Prokoudine A., Walk T., and Wiemer J. The use of metabolomics for the discovery of new biomarkers of effect. Toxicol Lett 172 (2007) 21-28
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Collings F.B., and Vaidya V.S. Novel technologies for the discovery and quantitation of biomarkers of toxicity. Toxicology 245 (2008) 167-174
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NCTR Research Accomplishments and Plans, FY2003-2004. U.S. Food and Drug Administration. National Center for Toxicological Research; 2004 (URL:http://www.fda.gov/nctr/science/03-04_Research_Plans/html/ofc_resea rch.html).
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26
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The human hepatoma HepaRG cells: a highly differentiated model for studies of liver metabolism and toxicity of xenobiotics
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Guillouzo A., Corlu A., Aninat C., Glaise D., Morel F., and Guguen-Guillouzo C. The human hepatoma HepaRG cells: a highly differentiated model for studies of liver metabolism and toxicity of xenobiotics. Chem Biol Interact 168 (2007) 66-73
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Skin biopsies for the measurement of clinical pharmacodynamic biomarkers
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28
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Assessing proliferation, cell-cycle arrest and apoptotic end points in human buccal punch biopsies for use as pharmacodynamic biomarkers in drug development
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An important study showing the feasibility of obtaining multiple skin biopsies from normal volunteers, and the suitability of these tissue specimens for the measurement of potential PD markers of cellular proliferation and apoptosis in oncology trials.
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Camidge D.R., Pemberton M.N., Growcott J.W., Johnstone D., Laud P.J., Foster J.R., Randall K.J., and Hughes A.M. Assessing proliferation, cell-cycle arrest and apoptotic end points in human buccal punch biopsies for use as pharmacodynamic biomarkers in drug development. Br J Cancer 93 (2005) 208-215. An important study showing the feasibility of obtaining multiple skin biopsies from normal volunteers, and the suitability of these tissue specimens for the measurement of potential PD markers of cellular proliferation and apoptosis in oncology trials.
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Br J Cancer
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Lefort K., and Dotto G.P. Notch signaling in the integrated control of keratinocyte growth/differentiation and tumor suppression. Semin Cancer Biol 14 (2004) 374-386
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Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib
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A significant study in which the investigators monitored the ability of erlotinib, a small-molecule EGFR tyrosine kinase inhibitor, to block autophosphorylation of EGFR in skin and in tumor biopsies and showed that the suppression of p-EGFR in skin with erlotinib treatment correlated with increased overall survival.
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Agulnik M., da Cunha Santos G., Hedley D., Nicklee T., dos Reis P.P., Ho J., Pond G.R., Chen H., Chen S., Shyr Y., et al. Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib. J Clin Oncol 25 (2007) 2184-2190. A significant study in which the investigators monitored the ability of erlotinib, a small-molecule EGFR tyrosine kinase inhibitor, to block autophosphorylation of EGFR in skin and in tumor biopsies and showed that the suppression of p-EGFR in skin with erlotinib treatment correlated with increased overall survival.
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Phase I pharmacokinetic/pharmacodynamic study of EKB-569, an irreversible inhibitor of the epidermal growth factor receptor tyrosine kinase, in combination with irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) in first-line treatment of patients with metastatic colorectal cancer
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Folprecht G., Tabernero J., Kohne C.-H., Zacharchuk C., Paz-Ares L., Rojo F., Quinn S., Casado E., Salazar R., Abbas R., et al. Phase I pharmacokinetic/pharmacodynamic study of EKB-569, an irreversible inhibitor of the epidermal growth factor receptor tyrosine kinase, in combination with irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) in first-line treatment of patients with metastatic colorectal cancer. Clin Cancer Res 14 (2008) 215-223
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Phase I clinical and pharmacodynamic evaluation of oral CI-1033 in patients with refractory cancer
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Zinner R.G., Nemunaitis J., Eiseman I., Shin H.J.C., Olson S.C., Christensen J., Huang X., Lenehan P.F., Donato N.J., and Shin D.M. Phase I clinical and pharmacodynamic evaluation of oral CI-1033 in patients with refractory cancer. Clin Cancer Res 13 (2007) 3006-3014
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