Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-04-22
2002-07-09
Wang, Andrew (Department: 1635)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C435S006120, C435S091100, C435S325000, C435S375000, C536S024500, C536S023100, C536S024300, C536S024310, C536S024330
Reexamination Certificate
active
06417169
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to oligonucleotides that are complementary to mammalian insulin-like growth factor II (IGF II) genes which oligonucleotides modulate tumor cell growth in mammals. This invention is also related to methods of using such compounds in inhibiting the growth of tumor cells in mammals. This invention also relates to pharmaceutical compositions comprising a pharmaceutically acceptable excipient and an effective amount of a compound of this invention.
2. References
The following publications, patent applications and patents are cited in this application:
1. Toretsky, J. A. and Helman, L. J. Involvement of IGF-II in human cancer, J Endocrinol. 149: 367-72, 1996.
2. Werner, H. and LeRoith, D. The role of the insulin-like growth factor system in human cancer, Adv Cancer Res. 68: 183-223, 1996.
3. Rogler, C. E., Yang, D., Rossetti, L., Donohoe, J., Alt, E., Chang, C. J., Rosenfeld, R., Neely, K., and Hintz, R. Altered body composition and increased frequency of diverse malignancies in insulin-like growth factor-II transgenic mice, J Biol Chem. 269: 13779-84, 1994.
4. Bates, P., Fisher, R., Ward, A., Richardson, L., Hill, D. J., and Graham, C. F. Mammary cancer in transgenic mice expressing insulin-like growth factor II (GF-II) [see comments], Br J Cancer. 72: 1189-93, 1995.
5. Cullen, K. J., Lippman, M. E., Chow, D., Hill, S., Rosen, N., and Zwiebel, J. A. Insulin-like growth factor-II overexpression in MCF-7 cells induces phenotypic changes associated with malignant progression, Mol Endocrinol. 6: 91-100, 1992.
6. Werner, H., Adamo, M., Roberts, C. T., Jr., and LeRoith, D. Molecular and cellular aspects of insulin-like growth factor action, Vitam Horm. 48: 1-58, 1994.
7. Curcio, L. D., Bouffard, D. Y., and Scanlon, K. J. Oligonucleotides as modulators of cancer gene expression, Pharmacol Ther. 74: 317-32, 1997.
8. Narayanan, R. and Akhtar, S. Antisense therapy, Curr Opin Oncol. 8: 509-15, 1996.
9. Ho, P. T. and Parkinson, D. R. Antisense oligonucleotides as therapeutics for malignant diseases, Semin Oncol. 24: 187-202, 1997.
10. Crooke, S. T. and Bennett, C. F. Progress in antisense oligonucleotide therapeutics, Annu Rev Pharmacol Toxicol. 36: 107-29, 1996.
11. Christofori, G., Naik, P., and Hanahan, D. A second signal supplied by insulin-like growth factor II in oncogene-induced tumorigenesis, Nature. 369: 414-8, 1994.
12. El-Badry, O. M., Minniti, C., Kohn, E. C., Houghton, P. J., Daughaday, W. H., and Helman, L. J. Insulin-like growth factor II acts as an autocrine growth and motility factor in human rhabdomyosarcoma tumors, Cell Growth Differ. 1: 325-31, 1990.
13. Kim, K. W., Bae, S. K., Lee, O. H., Bae, M. H., Lee, M. J., and Park, B. C. Insulin-like growth factor II induced by hypoxia may contribute to angiogenesis of human hepatocellular carcinoma, Cancer Res. 58: 348-51, 1998.
14. Volpert, O., Jackson, D., Bouck, N., and Linzer, D. I. The insulin-like growth factor II/mannose 6-phosphate receptor is required for proliferin-induced angiogenesis, Endocrinology. 137: 3871-6, 1996.
15. Lin, S. B., Hsieh, S. H., Hsu, H. L., Lai, M. Y., Kan, L. S., and Au, L. C. Antisense oligodeoxynucleotides of IGF-II selectively inhibit growth of human hepatoma cells overproducing IGF-II, J Biochem (Tokyo). 122: 717-22, 1997.
16. Steller, M. A., Delgado, C. H., Bartels, C. J., Woodworth, C. D., and Zou, Z. Overexpression of the insulin-like growth factor-1 receptor and autocrine stimulation in human cervical cancer cells, Cancer Res. 56: 1761-5, 1996.
17. Steller, M. A., Delgado, C. H., and Zou, Z. Insulin-like growth factor II mediates epidermal growth factor-induced mitogenesis in cervical cancer cells, Proc Natl Acad Sci U S A. 92: 11970-4, 1995.
18. Choy et al., “Molecular mechanisms of drug resistance involving ribonucleotide reductase: hydroxyurea resistance in a series of clonally related mouse cell lines selected in the presence of increasing drug concentrations”
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All of the above publications, patent applications and patents are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent application or patent was specifically and individually indicated to be incorporated by reference in its entirety.
3. State of the Art
Insulin-like growth factor II (IGF-II) is a 67 amino acid polypeptide growth factor that is widely expressed in the developing human embryonic tissues and is related to the growth and differentiation of various tissues. After birth, the expression is progressively extinguished in almost all human tissues. In adult humans, serum levels of approximately 100 ng/ml are mainly produced by the liver. The biological functions of IGF-II are mediated through its binding to either the IGF-II receptor (related to carbohydrate metabolism, motility of malignant cells and/or tumor-induced angiogenesis) or the IGF-I receptor (related to signal transduction pathway and mitogenesis).
IGF-II has been implicated in tumor progression and metastasis by a variety of mechanisms in many tumors (reviewed in (1, 2)). Tumors with extensive involvement of IGF-II include childhood tumors such as rhabdomyosarcoma, Wilms' tumor and neuroblastoma. These tumors demonstrate overexpression of IGF-II, show existence of a paracrine or autocrine loop and result in inhibition of tumor growth or metastasis upon blockage of the loop. IGF-II contributes to tumor growth and metastasis to varying degrees in a variety of tumors including osteosarcoma, breast carcinoma, hepatoblastoma, germ cell tumors, hepatocellular carcinoma, adrenocortical carcinoma, lung tumors, leiomyosarcoma, brain tumors and colon carcinoma. Furthermore, the direct role of IGF-II in oncogenesis has been elucidated by transgenic mice and human cell lines overexpressing it (3-5) .
The human IGF-II gene is located on chromosome 11p15 just downstream of insulin gene and spans 30 kb (reviewed in (6) ;see FIG.
1
).
Lee Yoon S.
Wright Jim A.
Young Aiping H.
Genesense Technologies Inc.
Gray Cary Ware & Freidenrich LLP
Haile Lisa A.
Lacourciere Karen A
Wang Andrew
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