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

Volumn 224, Issue 1, 2007, Pages 12-18

  Hsieh, Frank Y ^a   Tengstrand, Elizabeth ^a   Lee, Ju Whei ^c   Li, Lily Y ^c   Silverman, Lee ^b   Riordan, Bill ^b   Miwa, Gerald ^a   Milton, Mark ^c   Alden, Carl ^b   Lee, Frank ^b  

^a Nextcea Inc   (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

^c NONE

Author keywords

Antibody; Biologics; Biomarker; Immunoconjugate; MTD; Predictive toxicity; Safety evaluation; Toxicokinetics; Toxicology; Toxin

Indexed keywords

BIOLOGICAL MARKER; CYTOTOXIN; MLN 8666; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; BONE MARROW CELL; CONTROLLED STUDY; CYTOTOXICITY; DRUG CONJUGATION; DRUG SAFETY; HEMATOLOGICAL PARAMETERS; IN VIVO STUDY; MAXIMUM TOLERATED DOSE; MONKEY; NONHUMAN; OVARY CANCER; TOXICOLOGICAL PARAMETERS;

ANIMALS; ANTIBODIES; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BIOLOGICAL MARKERS; CHROMATOGRAPHY, LIQUID; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; IMMUNOTOXINS; MACACA FASCICULARIS; MASS SPECTROMETRY; MODELS, STATISTICAL; OVARIAN NEOPLASMS;

MACACA FASCICULARIS;

EID: 34548630543     PISSN: 0041008X     EISSN: 10960333     Source Type: Journal    
DOI: 10.1016/j.taap.2007.06.009     Document Type: Article

References (14)

1. Cheson B.D. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs 19 (2005) 309-322
2. Doronina S.O., Toki B.E., Torgov M.Y., Mendelsohn B.A., Cerveny C.G., Chace D.F., DeBlanc R.L., Gearing R.P., Bovee T.D., Siegall C.B., Francisco J.A., Wahl A.F., Meyer D.L., and Senter P.D. Development of potent monoclonal antibody auristatin conjugates for cancer therapy. Nat. Biotechnol. 21 (2003) 778-784
3. Golay J., Di Gaetano N., Amico D., Cittera E., Barbui A.M., Giavazzi R., Biondi A., Rambaldi A., and Introna M. Gemtuzumab ozogamicin (Mylotarg) has therapeutic activity against CD33 acute lymphoblastic leukaemias in vitro and in vivo. Br. J. Haematol. 128 (2005) 310-317
4. Henry M.D., Wen S., Silva M.D., Chandra S., Milton M., and Worland P.J. A prostate-specific membrane antigen-targeted monoclonal antibody-chemotherapeutic conjugate designed for the treatment of prostate cancer. Cancer Res. 64 (2004) 7995-8001
5. Linenberger M.L. CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance. Leukemia 19 (2005) 176-182
6. Lu S.X., Takach E.J., Solomon M., Zhu Q., Law S.J., and Hsieh F.Y. 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 (2005) 788-797
7. Mahler D.A., Huang S., Tabrizi M., and Bell G.M. Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study. Chest 126 (2004) 926-934
8. Mao W., Luis E., Ross S., Silva J., Tan C., Crowley C., Chui C., Franz G., Senter P., Koeppen H., and Polakis P. EphB2 as a therapeutic antibody drug target for the treatment of colorectal cancer. Cancer Res. 64 (2004) 781-788
9. Pusztai L., and Esteva F.J. Continued use of trastuzumab (herceptin) after progression on prior trastuzumab therapy in HER-2-positive metastatic breast cancer. Cancer Invest. 24 (2006) 187-191
10. Schwartzberg L.S. Clinical experience with edrecolomab: a monoclonal antibody therapy for colorectal carcinoma. Crit. Rev. Oncol. Hematol. 40 (2001) 17-24
11. Shih W.J. Prediction approaches to sequentially searching for an optimal dose. Biometrics 45 (1989) 623-628
12. Tabrizi M.A., Tseng C.M., and Roskos L.K. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today 11 (2006) 81-88
13. Yang X.D., Corvalan J.R., Wang P., Roy C.M., and Davis C.G. Fully human anti-interleukin-8 monoclonal antibodies: potential therapeutics for the treatment of inflammatory disease states. J. Leukoc. Biol. 66 (1999) 401-410
14. Xie H., Audette C., Hoffee M., Lambert J.M., and Blattler W.A. Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice. J. Pharmacol. Exp. Ther. 308 (2004) 1073-1082