Toxicological protein biomarker analysis - An investigative one-week single dose intravenous infusion toxicity and toxicokinetic study in cynomolgus monkeys using an antibody-cytotoxic conjugate against ovarian cancer

Pharmaceutical Research

Volumn 25, Issue 6, 2008, Pages 1309-1317

  Hsieh, Frank Y ^a   Tengstrand, Elizabeth ^a   Li, Lily Y ^c   Huang, Yuling N ^d   Milton, Mark N ^a   Silverman, Lee ^b   Alden, Carl ^b   Miwa, Gerald ^a   Lee, Frank ^b  

^a Nextcea Inc ^*  (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

^c New England Rehabilitation Hospital   (United States)

^d VERTEX PHARMACEUTICALS   (United States)

Author keywords

Biologics; Biomarker; Predictive toxicity; Toxicokinetics; Toxicology

Indexed keywords

AMYLOID A PROTEIN; ANTIBODY CONJUGATE; BIOLOGICAL MARKER; HAPTOGLOBIN; MLN 8866; PROTEIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; BLOOD SAMPLING; CYTOTOXICITY; DRUG CONJUGATION; DRUG EXPOSURE; FEMALE; HISTOPATHOLOGY; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; OVARY CANCER; PRIORITY JOURNAL; SINGLE DRUG DOSE; TOXICOKINETICS; TOXICOLOGY;

ANIMALS; ANTIBODIES; BIOLOGICAL MARKERS; FEMALE; HAPTOGLOBINS; IMMUNOTOXINS; INFUSIONS, INTRAVENOUS; MACACA FASCICULARIS; OVARIAN NEOPLASMS; SERUM AMYLOID A PROTEIN; SPECTROMETRY, MASS, MATRIX-ASSISTED LASER DESORPTION-IONIZATION;

EID: 43049147097     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9485-z     Document Type: Article

References (28)

1. 1. B. D. Cheson 2005 The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma BioDrugs 19 309 322 16207072 10.2165/00063030-200519050-00004 1:CAS:528:DC%2BD2MXht1amt7%2FF B. D. Cheson. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs 19:309–322 (2005).
2. 2. S. O. Doronina B. E. Toki M. Y. Torgov B. A. Mendelsohn C. G. Cerveny D. F. Chace R. L. DeBlanc R. P. Gearing T. D. Bovee C. B. Siegall J. A. Francisco A. F. Wahl D. L. Meyer P. D. Senter 2003 Development of potent monoclonal antibody auristatin conjugates for cancer therapy Nat. Biotechnol. 21 778 784 12778055 10.1038/nbt832 1:CAS:528:DC%2BD3sXkvFertLc%3D S. O. Doronina, B. E. Toki, M. Y. Torgov, B. A. Mendelsohn, C. G. Cerveny, D. F. Chace, R. L. DeBlanc, R. P. Gearing, T. D. Bovee, C. B. Siegall, J. A. Francisco, A. F. Wahl, D. L. Meyer, and P. D. Senter. Development of potent monoclonal antibody auristatin conjugates for cancer therapy. Nat. Biotechnol. 21:778–784 (2003).
3. 3. M. D. Henry S. Wen M. D. Silva S. Chandra M. Milton P. J. Worland 2004 A prostate-specific membrane antigen-targeted monoclonal antibody–chemotherapeutic conjugate designed for the treatment of prostate cancer Cancer Res. 64 7995 8001 15520207 10.1158/0008-5472.CAN-04-1722 1:CAS:528:DC%2BD2cXptFels7g%3D M. D. Henry, S. Wen, M. D. Silva, S. Chandra, M. Milton, and P. J. Worland. A prostate-specific membrane antigen-targeted monoclonal antibody–chemotherapeutic conjugate designed for the treatment of prostate cancer. Cancer Res. 64:7995–8001 (2004).
4. 4. S. X. Lu E. J. Takach M. Solomon Q. Zhu S. J. Law F. Y. Hsieh 2005 Mass spectral analyses of labile DOTA-NHS and heterogeneity determination of DOTA or DM1 conjugated anti-PSMA antibody for prostate cancer therapy J. Pharm. Sci. 94 788 797 15729708 10.1002/jps.20289 1:CAS:528:DC%2BD2MXjtFCjuro%3D S. X. Lu, E. J. Takach, M. Solomon, Q. Zhu, S. J. Law, and F. Y. Hsieh. Mass spectral analyses of labile DOTA-NHS and heterogeneity determination of DOTA or DM1 conjugated anti-PSMA antibody for prostate cancer therapy. J. Pharm. Sci. 94:788–797 (2005).
5. 5. W. Mao E. Luis S. Ross J. Silva C. Tan C. Crowley C. Chui G. Franz P. Senter H. Koeppen P. Polakis 2004 EphB2 as a therapeutic antibody drug target for the treatment of colorectal cancer Cancer Res. 64 781 788 14871799 10.1158/0008-5472.CAN-03-1047 1:CAS:528:DC%2BD2cXhtFCgt7s%3D W. Mao, E. Luis, S. Ross, J. Silva, C. Tan, C. Crowley, C. Chui, G. Franz, P. Senter, H. Koeppen, and P. Polakis. EphB2 as a therapeutic antibody drug target for the treatment of colorectal cancer. Cancer Res. 64:781–788 (2004).
6. 6. L. Pusztai F. J. Esteva 2006 Continued use of trastuzumab (herceptin) after progression on prior trastuzumab therapy in HER-2-positive metastatic breast cancer Cancer Invest. 24 187 191 16619408 10.1080/07357900500524629 1:CAS:528:DC%2BD28XisVarsbY%3D L. Pusztai, and F. J. Esteva. Continued use of trastuzumab (herceptin) after progression on prior trastuzumab therapy in HER-2-positive metastatic breast cancer. Cancer Invest. 24:187–191 (2006).
7. 7. L. S. Schwartzberg 2001 Clinical experience with edrecolomab: a monoclonal antibody therapy for colorectal carcinoma Crit. Rev. Oncol. Hematol. 40 17 24 11578913 10.1016/S1040-8428(01)00131-7 1:STN:280:DC%2BD3Mrjt1WltA%3D%3D L. S. Schwartzberg. Clinical experience with edrecolomab: a monoclonal antibody therapy for colorectal carcinoma. Crit. Rev. Oncol. Hematol. 40:17–24 (2001).
8. 8. J. Golay N. Gaetano Di D. Amico E. Cittera A. M. Barbui R. Giavazzi A. Biondi A. Rambaldi M. Introna 2005 Gemtuzumab ozogamicin (Mylotarg) has therapeutic activity against CD33 acute lymphoblastic leukaemias in vitro and in vitro Br. J. Haematol. 128 3 310 317 15667532 10.1111/j.1365-2141.2004.05322.x 1:CAS:528:DC%2BD2MXitFOhu74%3D J. Golay, N. Di Gaetano, D. Amico, E. Cittera, A. M. Barbui, R. Giavazzi, A. Biondi, A. Rambaldi, and M. Introna. Gemtuzumab ozogamicin (Mylotarg) has therapeutic activity against CD33 acute lymphoblastic leukaemias in vitro and in vivo. Br. J. Haematol. 128 (3):310–317 (2005).
9. 9. M. L. Linenberger 2005 CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance Leukemia. 19 2 176 182 15592433 10.1038/sj.leu.2403598 1:CAS:528:DC%2BD2MXmtlOqug%3D%3D M. L. Linenberger. CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance. Leukemia. 19 (2):176–182 (2005).
10. 10. M. Collins V. Ling B. M. Carreno 2005 The B7 family of immune-regulatory ligands Genome Biol. 6 6 223 15960813 10.1186/gb-2005-6-6-223 M. Collins, V. Ling, and B. M. Carreno. The B7 family of immune-regulatory ligands. Genome Biol. 6 (6):223 (2005).
11. 11. M. Ichikawa L. Chen 2005 Role of B7-H1 and B7-H4 molecules in down-regulating effector phase of T-cell immunity: novel cancer escaping mechanisms Front Biosci. 10 2856 2860 15970540 10.2741/1742 1:CAS:528:DC%2BD2MXntFGisbg%3D M. Ichikawa, and L. Chen. Role of B7-H1 and B7-H4 molecules in down-regulating effector phase of T-cell immunity: novel cancer escaping mechanisms. Front Biosci. 10:2856–2860 (2005).
12. 12. I. H. Choi G. Zhu G. L. Sica S. E. Strome J. C. Cheville J. S. Lau Y. Zhu D. B. Flies K. Tamada L. Chen 2003 Genomic organization and expression analysis of B7-H4, an immune inhibitory molecule of the B7 family J. Immunol. 171 9 4650 4654 14568939 1:CAS:528:DC%2BD3sXot1Cntr8%3D I. H. Choi, G. Zhu, G. L. Sica, S. E. Strome, J. C. Cheville, J. S. Lau, Y. Zhu, D. B. Flies, K. Tamada, and L. Chen. Genomic organization and expression analysis of B7-H4, an immune inhibitory molecule of the B7 family. J. Immunol. 171 (9):4650–4654 (2003).
13. 13. G. L. Sica I. H. Choi G. Zhu K. Tamada S. D. Wang H. Tamura A. I. Chapoval D. B. Flies J. Bajorath L. Chen 2003 B7-H4, a molecule of the B7 family, negatively regulates T cell immunity Immunity. 18 849 861 12818165 10.1016/S1074-7613(03)00152-3 1:CAS:528:DC%2BD3sXltFals70%3D G. L. Sica, I. H. Choi, G. Zhu, K. Tamada, S. D. Wang, H. Tamura, A. I. Chapoval, D. B. Flies, J. Bajorath, and L. Chen. B7-H4, a molecule of the B7 family, negatively regulates T cell immunity. Immunity. 18:849–861 (2003).
14. 14. M. J. Aardema J. T. MacGregor 2002 Toxicology and genetic toxicology in the new era of “toxicogenomics”: impact of “-omics” technologies Mutation Res. 499 13 25 11804602 1:CAS:528:DC%2BD38Xms1Gjug%3D%3D M. J. Aardema, and J. T. MacGregor. Toxicology and genetic toxicology in the new era of “toxicogenomics”: impact of “-omics” technologies. Mutation Res. 499:13–25 (2002).
15. 15. C. D. Collins S. Purohit R. H. Zhao D. Schatz S. E. Eckenrode P. Yang D. Hopkins A. Muir M. Hoffman R. A. McIndoe M. Rewers J. X. She 2006 The application of genomic and proteomic technologies in predictive, preventative and personalized medicine Vascular Pharm. 45 258 267 10.1016/j.vph.2006.08.003 1:CAS:528:DC%2BD28Xht1CqtbbP C. D. Collins, S. Purohit, R. H. Zhao, D. Schatz, S. E. Eckenrode, P. Yang, D. Hopkins, A. Muir, M. Hoffman, R. A. McIndoe, M. Rewers, and J. X. She. The application of genomic and proteomic technologies in predictive, preventative and personalized medicine. Vascular Pharm. 45:258–267 (2006).
16. 16. B. A. Merrick M. E. Bruno 2004 Genomic and proteomic profiling for biomarkers and signature profiles of toxicity Curr. Op. Mol. Ther. 6 600 607 1:CAS:528:DC%2BD2MXpsFSruw%3D%3D B. A. Merrick, and M. E. Bruno. Genomic and proteomic profiling for biomarkers and signature profiles of toxicity. Curr. Op. Mol. Ther. 6:600–607 (2004).
17. 17. A. Sinha C. Singh D. Parmar M. P. Singh 2007 Proteomics in clinical interventions: achievements and limitations in biomarker development Life Sciences 80 1345 1354 17210164 10.1016/j.lfs.2006.12.005 1:CAS:528:DC%2BD2sXislKgtrY%3D A. Sinha, C. Singh, D. Parmar, and M. P. Singh. Proteomics in clinical interventions: achievements and limitations in biomarker development. Life Sciences 80:1345–1354 (2007).
18. 18. F. Hsieh E. Tengstrand J. W. Lee L. Li L. Silverman B. Riordan G. Miwa M. Milton C. Alden F. Lee 2007 Drug safety evaluation through biomarker analysis—a toxicity study in the cynomolgus monkey using an antibody-cytotoxic conjugate against ovarian cancer Toxicology and Applied Pharmacology 224 12 18 17681578 10.1016/j.taap.2007.06.009 1:CAS:528:DC%2BD2sXhtVOgu7fM F. Hsieh, E. Tengstrand, J. W. Lee, L. Li, L. Silverman, B. Riordan, G. Miwa, M. Milton, C. Alden, and F. Lee. Drug safety evaluation through biomarker analysis—a toxicity study in the cynomolgus monkey using an antibody-cytotoxic conjugate against ovarian cancer. Toxicology and Applied Pharmacology 224:12–18 (2007).
19. 19. E. Baronas J. W. Lee C. Alden F. Hsieh 2007 Biomarkers to monitor drug-induced phospholipidosis Toxicol. Appl. Pharmacol. 218 72 78 17156806 10.1016/j.taap.2006.10.015 1:CAS:528:DC%2BD2sXitl2htQ%3D%3D E. Baronas, J. W. Lee, C. Alden, and F. Hsieh. Biomarkers to monitor drug-induced phospholipidosis. Toxicol. Appl. Pharmacol. 218:72–78 (2007).
20. 20. C. Gabay I. Kushner 1999 Acute-phase proteins and other systemic responses to inflammation New England J. Med. 11 448 454 10.1056/NEJM199902113400607 C. Gabay, and I. Kushner. Acute-phase proteins and other systemic responses to inflammation. New England J. Med. 11:448–454 (1999) Feb.
21. 21. E. Malle F. C. Beer De 1996 Human serum amyloid A (SAA) protein: a prominent acute-phase reactant for clinical practice Eur. J. Clin. Invest. 26 6 427 435 8817153 10.1046/j.1365-2362.1996.159291.x 1:STN:280:BymH3MvgvFc%3D E. Malle, and F. C. De Beer. Human serum amyloid A (SAA) protein: a prominent acute-phase reactant for clinical practice. Eur. J. Clin. Invest. 26 (6):427–435 (1996).
22. 22. S. Pajovic V. E. Jones K. R. Prowse F. G. Berger H. Baumann 1994 Species-specific changes in regulatory elements of mouse haptoglobin genes J. Biological Chem. 269 3 2215 2224 1:CAS:528:DyaK2cXhsFGlsL8%3D S. Pajovic, V. E. Jones, K. R. Prowse, F. G. Berger, and H. Baumann. Species-specific changes in regulatory elements of mouse haptoglobin genes. J. Biological Chem. 269 (3):2215–2224 (1994).
23. 23. Y. Wang E. Kinzie F. G. Berger S. K. Lim H. Baumann 2001 Haptoglobin, an inflammation-inducible plasma protein Redox Rep. 6 6 379 385 11865981 10.1179/135100001101536580 1:CAS:528:DC%2BD38XhvFOhu7c%3D Y. Wang, E. Kinzie, F. G. Berger, S. K. Lim, and H. Baumann. Haptoglobin, an inflammation-inducible plasma protein. Redox Rep. 6 (6):379–385 (2001).
24. 24. K. Carter M. Worwood 2007 Haptoglobin: a review of the major allele frequencies worldwide and their association with diseases Int. J. Lab Hematol. 29 2 92 110 17474882 10.1111/j.1751-553X.2007.00898.x K. Carter, and M. Worwood. Haptoglobin: a review of the major allele frequencies worldwide and their association with diseases. Int. J. Lab Hematol. 29 (2):92–110 (2007).
25. 25. M. A. Tabrizi C. M. Tseng L. K. Roskos 2006 Elimination mechanisms of therapeutic monoclonal antibodies Drug Discovery Today 11 1/2 81 88 16478695 10.1016/S1359-6446(05)03638-X 1:CAS:528:DC%2BD28XhsFygt70%3D M. A. Tabrizi, C. M. Tseng, and L. K. Roskos. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discovery Today 11 (1/2):81–88 (2006).
26. 26. X. D. Yang J. R. Corvalan P. Wang C. M. Roy C. G. Davis 1999 Fully human anti-interleukin-8 monoclonal antibodies: potential therapeutics for the treatment of inflammatory disease states J. Leukoc. Biol. 66 401 410 10496309 1:CAS:528:DyaK1MXmtFequ74%3D X. D. Yang, J. R. Corvalan, P. Wang, C. M. Roy, and C. G. Davis. Fully human anti-interleukin-8 monoclonal antibodies: potential therapeutics for the treatment of inflammatory disease states. J. Leukoc. Biol. 66:401–410 (1999).
27. 27. D. A. Mahler S. Huang M. Tabrizi G. M. Bell 2004 Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study Chest 126 926 934 15364775 10.1378/chest.126.3.926 1:CAS:528:DC%2BD2cXovVyks7w%3D D. A. Mahler, S. Huang, M. Tabrizi, and G. M. Bell. Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study. Chest 126:926–934 (2004).
28. 28. H. Xie C. Audette M. Hoffee J. M. Lambert W. A. Blattler 2004 Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice J. Pharmacol. Exp. Ther. 308 3 1073 1082 14634038 10.1124/jpet.103.060533 1:CAS:528:DC%2BD2cXhvVWnur0%3D H. Xie, C. Audette, M. Hoffee, J. M. Lambert, and W. A. Blattler. Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice. J. Pharmacol. Exp. Ther. 308 (3):1073–1082 (2004).