Toxicology profiles of a novel p53-Armed replication-competent oncolytic adenovirus in Rodents, Felids, and Nonhuman primates

Toxicological Sciences

Volumn 106, Issue 1, 2008, Pages 242-250

  Su, Changqing ^a   Cao, Hui ^b   Tan, Shuping ^b   Huang, Yao ^a   Jia, Xiaoyuan ^c   Jiang, Lixin ^b   Wang, Kai ^b   Chen, Ying ^b   Long, Ju ^c   Liu, Xinyuan ^c   Wu, Mengchao ^a   Wu, Xiaobing ^b   Qian, Qijun ^a,c  

^a SECOND MILITARY MEDICAL UNIVERSITY   (China)

^b AGTC Gene Technology Company Ltd   (China)

^c ZHEJIANG SCI TECH UNIVERSITY   (China)

Author keywords

Conditionally replicating adenovirus; Human telomerase reverse transcriptase; Hypoxia response element; p53 gene; Safety evaluation

Indexed keywords

ALBUMIN; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; E1A PROTEIN; E1B PROTEIN; HEMOGLOBIN; ONCOLYTIC VIRUS; PROTEIN P53; RNA DIRECTED DNA POLYMERASE; VIRUS ANTIBODY;

ADENOVIRUS; ANAPHYLAXIS; ANIMAL BEHAVIOR; ANIMAL EXPERIMENT; ANTIBODY PRODUCTION; ARTICLE; BONE MARROW EXAMINATION; CACHEXIA; CANCER GENE THERAPY; CARDIOVASCULAR SYSTEM; CAT; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG MEGADOSE; DRUG SAFETY; DRUG SENSITIZATION; ERYTHROCYTE COUNT; EYELID CLOSURE; FEMALE; GENE DELETION; GENETIC REGULATION; GUINEA PIG; HEMATOCRIT; HISTOPATHOLOGY; INJECTION SITE INFLAMMATION; LEUKOCYTE COUNT; LOW DRUG DOSE; MALE; MONKEY; MOUSE; NERVOUS SYSTEM; NONHUMAN; ONCOLYTIC VIROTHERAPY; ORGAN WEIGHT; PHYSICAL ACTIVITY; PRIMATE; PROMOTER REGION; RAT; RESPIRATORY SYSTEM; RODENT; THROMBOCYTE COUNT; TOXICITY TESTING; VIRUS REPLICATION;

ADENOVIRIDAE; ADENOVIRUS E1A PROTEINS; ADENOVIRUS E1B PROTEINS; ANAPHYLAXIS; ANIMALS; BEHAVIOR, ANIMAL; CARDIOVASCULAR SYSTEM; CATS; FEMALE; GENETIC VECTORS; GUINEA PIGS; MACACA FASCICULARIS; MALE; MICE; NERVOUS SYSTEM; ONCOLYTIC VIROTHERAPY; ONCOLYTIC VIRUSES; PROMOTER REGIONS, GENETIC; RATS; RATS, WISTAR; RESPIRATORY SYSTEM; TELOMERASE; TIME FACTORS; TOXICITY TESTS; TUMOR SUPPRESSOR PROTEIN P53; VIRUS REPLICATION;

ADENOVIRIDAE; ANIMALIA; CAVIA; FELIDAE; MACACA FASCICULARIS; MUS; PRIMATES; RATTUS; RODENTIA;

EID: 54549084575     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfn168     Document Type: Article

References (39)

1. Bauerschmitz, G. J., Barker, S. D., and Hemminki, A. (2002). Adenoviral gene therapy for cancer: From vectors to targeted and replication competent agents (review). Int. J. Oncol. 21, 1161-1174.
2. Bauerschmitz, G. J., Kanerva, A., Wang, M., Herrmann, I., Shaw, D. R., Strong, T. V., Desmond, R., Rein, D. T., Dall, P., Curiel, D. T., et al. (2004). Evaluation of a selectively oncolytic adenovirus for local and systemic treatment of cervical cancer. Int. J. Cancer 111, 303-309.
3. Cha, C., and Dematteo, R. P. (2005). Molecular mechanisms in hepatocellular carcinoma development. Best Pract. Res. Clin. Gastroenterol. 19, 25-37.
4. DeWeese, T. L., van der Poel, H., Li, S., Mikhak, B., Drew, R., Goemann, M., Hamper, U., DeJong, R., Detorie, N., Rodriguez, R., et al. (2001). A phase I trial of CV706, a replication-competent, PSA selective oncolytic adenovirus, for the treatment of locally recurrent prostate cancer following radiation therapy. Cancer Res. 61, 7464-7472.
5. Ganly, I., Kirn, D., Eckhardt, G., Rodriguez, G. I., Soutar, D. S., Otto, R., Robertson, A. G., Park, O., Gulley, M. L., Heise, C., et al. (2000). A phase I study of Onyx-015, an E1B attenuated adenovirus, administered intratumorally to patients with recurrent head and neck cancer. Clin. Cancer Res. 6, 798-806.
6. Giehl, K. (2005). Oncogenic Ras in tumour progression and metastasis. Biol. Chem. 386, 193-205.
7. Guan, Y. S., Liu, Y., Zhou, X. P., Li, X., He, Q., and Sun, L. (2005). p53 gene (Gendicine) and embolisation overcame recurrent hepatocellular carcinoma. Gut 54, 1318-1319.
8. Ha, P. K., and Califano, J. A. (2006). Promoter methylation and inactivation of tumour-suppressor genes in oral squamous-cell carcinoma. Lancet Oncol. 7, 77-82.
9. Haupt, S., and Haupt, Y. (2004). Manipulation of the tumor suppressor p53 for potentiating cancer therapy. Semin. Cancer Biol. 14, 244-252.
10. Horowitz, J. (1999). Adenovirus-mediated p53 gene therapy: Overview of preclinical studies and potential clinical applications. Curr. Opin. Mol. Ther. 1, 500-509.
11. Kirn, D. (2001). Clinical research results with dl1520 (Onyx-015), a replication-selective adenovirus for the treatment of cancer: What have we learned? Gene Ther. 8, 89-98.
12. Lai, C. M., Lai, Y. K., and Rakoczy, P. E. (2002). Adenovirus and adeno-associated virus vectors. DNA Cell Biol. 21, 895-913.
13. Li, Y., Idamakanti, N., Arroyo, T., Thorne, S., Reid, T., Nichols, S., VanRoey, M., Colbern, G., Nguyen, N., Tam, O., et al. (2005). Dual promoter-controlled oncolytic adenovirus CG5757 has strong tumor selectivity and significant antitumor efficacy in preclinical models. Clin. Cancer Res. 11, 8845-8855.
14. Lu, W., Zheng, S., Li, X. F., Huang, J. J., Zheng, X., and Li, Z. (2004). Intratumor injection of H101, a recombinant adenovirus, in combination with chemotherapy in patients with advanced cancers: A pilot phase II clinical trial. World J. Gastroenterol. 10, 3634-3638.
15. Lutz, W., and Nowakowska-Swirta, E. (2002). Gene p53 mutations, protein p53, and anti-p53 antibodies as biomarkers of cancer process. Int. J. Occup. Med. Environ. Health 15, 209-218.
16. Makower, D., Rozenblit, A., Kaufman, H., Edelman, M., Lane, M. E., Zwiebel, J., Haynes, H., and Wadler, S. (2003). Phase II clinical trial of intralesional administration of the oncolytic adenovirus ONYX-015 in patients with hepatobiliary tumors with correlative p53 studies. Clin. Cancer Res. 9, 693-702.
17. Mathis, J. M., Stoff-Khalili, M. A., and Curiel, D. T. (2005). Oncolytic adenoviruses-selective retargeting to tumor cells. Oncogene 24 7775-7791.
18. Matsubara, H., Kimura, M., Sugaya, M., Koide, Y., Gunji, Y., Takegana, K., Asano, T., Ochiai, T., Isono, K., Sakiyama, S., et al. (1999). Expression of wild-type p53 gene confers increased sensitivity to radiation and chemotherapeutic agents in human esophageal carcinoma cells. Int. J. Oncol. 14, 1081-1085.
19. Munro, A. J., Lain, S., and Lane, D. P. (2005). P53 abnormalities and outcomes in colorectal cancer, a systematic review. Br. J. Cancer 92, 434-444.
20. Nakatani, T., Kuriyama, S., Tominaga, K., Tsujimoto, T., Mitoro, A., Yamazaki, M., Tsujinoue, H., Yoshiji, H., Nagao, S., and Fukui, H. (2000). Assessment of efficiency and safety of adenovirus mediated gene transfer into normal and damaged murine livers. Gut 47, 563-570.
21. Nemunaitis, J., Ganly, I., Khuri, F., Arseneau, J., Kuhn, J., McCarty, T., Landers, S., Maples, P., Romel, L., Randlev, B., et al. (2000). Selective replication and oncolysis in p53 mutant tumors with ONYX-015, an E1B-55kD gene-deleted adenovirus, in patients with advanced head and neck cancer, a phase II trial. Cancer Res. 60, 6359-6366.
22. Nettelbeck, D. M. (2003). Virotherapeutics, conditionally replicative adenoviruses for viral oncolysis. Anticancer Drugs 14, 577-584.
23. Page, J. G., Tian, B., Schweikart, K., Tomaszewski, J., Harris, R., Broadt, T., Polley-Nelson, J., Noker, P. E., Wang, M., Makhija, S., et al. (2007). Identifying the safety profile of a novel infectivity-enhanced conditionally replicative adenovirus, Ad5-delta24-RGD, in anticipation of a phase I trial for recurrent ovarian cancer. Am. J. Obstet. Gynecol. 196, 389.e1-389.e19; discussion 389.e9-10.
24. Palmer, D. H., Mautner, V., and Kerr, D. J. (2002). Clinical experience with adenovirus in cancer therapy. Curr. Opin. Mol. Ther. 4, 423-434.
25. Payne, S. R., and Kemp, C. J. (2005). Tumor suppressor genetics. Carcinogenesis 26, 2031-2045.
26. Pirollo, K. F., Bouker, K. B., and Chang, E. H. (2000). Does p53 status influence tumor response to anticancer therapies? Anticancer Drugs 11, 419-432.
27. Reid, T., Galanis, E., Abbruzzese, J., Sze, D., Andrews, J., Romel, L., Hatfield, M., Rubin, J., and Kim, D. (2001). Intra-arterial administration of a replication-selective adenovirus (dl1520) in patients with colorectal carcinoma metastatic to the liver, a phase I trial. Gene Ther. 8, 1618-1626.
28. Robson, T., Worthington, J., McKeown, S. R., and Hirst, D. G. (2005). Radiogenic therapy, novel approaches for enhancing tumor radiosensitivity. Technol. Cancer Res. Treat. 4, 343-361.
29. Roth, J. A. (2006). Adenovirus p53 gene therapy. Expert Opin. Biol. Ther. 6, 55-61.
30. Somasundaram, K. (2000). Tumor suppressor p53, regulation and function. Front. Biosci. 5, D424-D437.
31. Soussi, T., and Lozano, G. (2005). p53 mutation heterogeneity in cancer. Biochem. Biophys. Res. Commun. 331, 834-842.
32. Su, C., Peng, L., Sham, J., Wang, X., 2hang, Q., Chua, D., Liu, C., Cui, Z., Xue, H., Wu, H., et al. (2006). Immune gene-viral therapy with triplex efficacy mediated by oncolytic adenovirus carrying an interferon-gamma gene yields efficient antitumor activity in immunodeficient and immuno-competent mice. Mol. Ther. 13, 918-927.
33. Su, C. Q., Sham, J., Xue, H. B., Wang, X. H., Chua, D., Cui, Z. F., Peng, L. H., Li, L. F., Jiang, L. H., Wu, M. C., et al. (2004). Potent antitumoral efficacy of a novel replicative adenovirus CNHK300 targeting telomerase-positive cancer cells. J. Cancer Res. Clin. Oncol. 130, 591-603.
34. Tango, Y., Taki, M., Shirakiya, Y., Ohtani, S., Tokunaga, N., Tsunemitsu, Y., Kagawa, S., Tani, T., Tanaka, N., and Fujiwara, T. (2004). Late resistance to adenoviral p53-mediated apoptosis caused by decreased expression of Coxsackie-adenovirus receptors in human lung cancer cells. Cancer Sci. 95, 459-463.
35. Vamavski, A. N., Calcedo, R., Bove, M., Gao, G., and Wilson, J. M. (2005). Evaluation of toxicity from high-dose systemic administration of recombinant adenovirus vector in vector-naive and pre-immunized mice. Gene Ther. 12, 427-436.
36. Ventura, A., Kirsch, D. G., McLaughlin, M. E., Tuveson, D. A., Grimm, J., Lintault, L., Newman, J., Reezek, E. E., Weissleder, R., and Jacks, T. (2007). Restoration of p53 function leads to tumour regression in vivo. Nature 445, 606-607.
37. Wang, X., Su, C., Cao, H., Li, K., Chen, J., Jiang, L., Zhang, Q., Wu, X., Jia, X., Liu, Y., et al. (2008). A novel triple-regulated oncolytic adenovirus carrying p53 gene exerts potent antitumor efficacy on common human solid cancers. Mol. Cancer Ther. 7, 1598-1603.
38. Wilson, D. R. (2002). Viral-mediated gene transfer for cancer treatment. Curr. Pharm. Biotechnol. 3, 151-164.
39. Xue, W., Zender, L., Miething, C., Dickins, R. A., Hernando, E., Krizhanovsky, V., Cordon-Cardo, C., and Lowe, S. W. (2007). Senescence and tumour clearance is triggered by p53 restoration in murine liver carcinomas. Nature 445, 606-607.