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• W4361950990 abstract "<div>Abstract<p><b>Purpose:</b> To evaluate γ-H2AX foci as a pharmacodynamic marker for DNA damage induced by DNA interstrand cross-linking drugs.</p><p><b>Experimental Design:</b> γ-H2AX foci formation was validated preclinically in comparison with the Comet assay, and evaluated pharmacodynamically in two phase I studies of different dosing schedules of the novel cross-linking agent SJG-136 (SG2000).</p><p><b>Results:</b> The measurement of γ-H2AX foci in human fibroblasts and lymphocytes <i>in vitro</i> was more than 10-fold more sensitive than Comet assay measurement of cross-linking, with peak γ-H2AX response 24 hours after the peak of cross-linking. In lymphocytes from a phase I study (every three week schedule), γ-H2AX foci were detectable 1 hour following the end of administration, and in all patients, maximum response was observed at 24 hours. Significant levels of foci were still evident at days 8 and 15 consistent with the known persistence of the DNA damage produced by this agent. In two tumor biopsy samples, foci were detected 4 hours postinfusion with levels higher than in lymphocytes. Extensive foci formation was also observed before the third dose in cycle 1 in lymphocytes from a second phase I study (daily × 3 schedule). These foci also persisted with a significant level evident before the second cycle (day 21). An increased γ-H2AX response was observed during the second cycle consistent with a cumulative pharmacodynamic effect. No clear relationship between foci formation and administered drug dose was observed.</p><p><b>Conclusion:</b> This is the first use of γ-H2AX as a pharmacodynamic response to a DNA cross-linking agent in a clinical trial setting. <i>Clin Cancer Res; 19(3); 721–30. ©2012 AACR</i>.</p></div>" @default.
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• W4361950990 date "2023-03-31" @default.
• W4361950990 modified "2023-09-26" @default.
• W4361950990 title "Data from γ-H2AX Foci Formation as a Pharmacodynamic Marker of DNA Damage Produced by DNA Cross-Linking Agents: Results from 2 Phase I Clinical Trials of SJG-136 (SG2000)" @default.
• W4361950990 doi "https://doi.org/10.1158/1078-0432.c.6522023.v1" @default.
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