Effects of natalizumab, an α4 integrin inhibitor, on the development of hartley guinea pigs

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 86, Issue 2, 2009, Pages 98-107

  Wehner, Nancy G ^a   Shopp, George ^b   Rocca, Meredith S ^c   Clarke, Janet ^d  

^a ELAN PHARMACEUTICALS   (United States)

^b Shopp Nonclinical Consulting LLC   (United States)

^c TherImmune Research Corporation   (United States)

^d BIOGEN   (United States)

Author keywords

4 integrin; Embryo fetal development; Guinea pig; Monoclonal antibody; Natalizumab; Safety assessment

Indexed keywords

NATALIZUMAB; ALPHA4 INTEGRIN; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; DRUG EFFECT; DRUG EXPOSURE; DRUG MEGADOSE; EMBRYO DEVELOPMENT; FEMALE; FETOTOXICITY; FETUS; FETUS DEVELOPMENT; GESTATION PERIOD; GUINEA PIG; HEART; HISTOPATHOLOGY; INTESTINE; LIVER; LOW DRUG DOSE; MALE; MATING; NONHUMAN; ORGANOGENESIS; PREGNANCY; PRIORITY JOURNAL; RISK ASSESSMENT; SKELETON MALFORMATION; SPLEEN; TERATOGENICITY; THYMUS; ANIMAL; ANTIBODY PRODUCTION; BLOOD; COMPARATIVE STUDY; CONGENITAL MALFORMATION; DOSE RESPONSE; DRUG SCREENING; IMMUNOLOGY; PRENATAL DEVELOPMENT; RANDOMIZATION;

CAVIA;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, MONOCLONAL; ANTIBODY FORMATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; EMBRYONIC DEVELOPMENT; FEMALE; FETUS; GUINEA PIGS; INTEGRIN ALPHA4; ORGANOGENESIS; PREGNANCY; RANDOM ALLOCATION;

EID: 65549090686     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20189     Document Type: Article

References (33)

1. Aluvihare VR, Kallikourdis M, Betz AG. 2005. Tolerance, suppression and the fetal allograft. J Mol Med 83:88-96.
2. Arroyo AG, Yang JT, Rayburn H, Hynes RO. 1996. Differential requirements for α4 integrins during fetal and adult hematopoiesis. Cell 85:997-1008.
3. Batista MC, Bristow TL, Mathews J, Stokes WS, Loriaux DL, Nieman LK. 1991. Daily administration of the progesterone antagonist RU 486 prevents implantation in the cycling guinea pig. Am J Obstet Gynecol 165:82-86.
4. Crofts F, Pino M, DeLise B, Guittin P, Barbellion S, Brunei P, Potdevin S, Bergmann B, Hofmann T, Lerman S, Clark RL. 2004. Different embryo-fetal toxicity effects for three VLA-4 antagonists. Birth Defects Res B Dev Reprod Toxicol 71:55-68.
5. Danese S, Semeraro S, Marini M, Robert I, Armuzzi A, Papa A, Gasbarrini A. 2005. Adhesion molecules in inflammatory bowel disease: Therapeutic implications for gut inflammation. Dig Liver Dis 37:811-818.
6. De Rijk EPCT, van Esch E. 2008. The macaque placenta: A mini-review. Toxicol Pathol 36:108S-118S.
7. DeSesso JM. 1997. Comparative embryology. In: Hood RD, editor. Handbook of developmental toxicology. New York: CRC Press, p 111-173.
8. Dunnett CW. 1964. New tables for multiple comparisons with a control. Biometrics 20:482-491.
9. Fujimoto K, Terao K, Cho F, Honjo S. 1983. The placenta] transfer of IgG in the cynomolgus monkey. Jpn J Med Sci Biol 36:171-176.
10. Garty BZ, Ludomirsky A, Danon YL, Peter JB, Douglas SD. 1994. Placental transfer of immunoglobulin G subclasses. Clin Diag Lab Immunol 1:667-669.
11. Gurtner GC, Davis V, Li H, McCoy MJ, Sharpe A, Cybulsky MI 1995. Targeted disruption of the murine VCAM1 gene: Essential role of VCAM-1 in chorioallantoic fusion and placentation. Genes Dev 9: 1-14.
12. ICH Guideline for Industry. 1994. Detection of toxicity to reproduction for medicinal products. FDA Web site, http://www.fda.gov/cder/Guidance/s5a.pdf, Accessed July 11, 2008.
13. Iizuka T, Tanka T, Suematsu M, Miura S, Watanabe T, Koike R, Ishimura Y, Ishii H, Miyasaka N, Miyasaka M. 2000. Stage-specific expression of mucosal addressin cell adhesion molecule-1 during embryogenesis in rats. J Immunol 164:2463-2471.
14. Jacquet P, Vankerkom J, Labiet-Collier M. 1994. The female guinea pig, a useful model for the genetic hazard of radiation in man; preliminary results on germ cell radiosensitivity in foetal, neonatal and adult animals. Int J Radiat Biol 65:357-367.
15. Jaspers M, Wu RR, Van der Schueren B, Cassiman JJ. 1995. Localization of alpha 4m integrin at sites of mesenchyme condensation during embryonic mouse development. Dif ferentiation 59:79-86.
16. Kronick JB, Whelan DT, McCallion DJ. 1987. Experimental hyperpheny-lalaninemia in the pregnant guinea pig: Possible phenylalanine teratogenesis and p-chlorophenylalanine embryotoxicity. Teratology 36:245-258.
17. Kruskal WH, Wallis WA. 1952. Use of ranks in one-criterion variance analysis, J Am Stat Assoc 47:583-621.
18. Kwee L, Baldwin HS, Shen HM, Stewart CL, Buck C, Buck CA, Labow MA. 1995. Defective development of the embryonic and extra embryonic circulatory systems in vascular cell adhesion molecule (VCAM-1) deficient mice. Development 121:489-503.
19. Leissring JC, Anderson JW. 1961. The transfer of serum proteins from mother to young in the guinea pig. I. Prenatl rates and routes. Am J Anat 109:149-155.
20. Lim WC, Hanauer SB. 2004. Emerging biologic therapies in inflammatory bowel disease. Rev Gastroenterol Disord 4:66-85.
21. Malek A, Sager R, Kuhn P, Nicolaides KH, Schneider H. 1996. Evolution of maternofetal transport of immunoglobulins during human pregnancy. Am J Reprod Immunol 36:248-255.
22. MARTA/MTA historical control database of pre-clinical developmental teratology and reproductive toxicity parameters. A joint project of Middle Atlantic Reproduction and Teratology Association (MARTA) and Midwest Teratology Association (MTA). http://www.hcd.org/search/abnormality.asp. Accessed October 21, 2008.
23. Rocca MS, Wehner NG. 2009. The guinea pig as an animal model for developmental and reproductive toxicology studies. Birth Defects Res B Dev Reprod Toxicol; submitted.
24. Sengbusch JK, He W, Pinko KA, Yang JT. 2002. Dual functions of α4pl integrin in epicardial development: Initial migration and long-term attachment. J Cell Biol 157:873-882.
25. Sheppard AM, Onken MD, Rosen GD, Noakes PG, Dean DC. 1994. Expanding roles for α4 integrin and its ligands in development. Cell Adlies Commun 2:27-43.
26. Smith MS, Upfold JB, Edwards MJ, Shiota K, Cawdell-Smith J. 1992. The induction of neural tube defects by maternal hyperthermia: A comparison of the guinea-pig and human. Neuropathol Appl Neurobiol 18:71-80.
27. Sueoka K, Shiokawa S, Miyazaki T, Kuji N, Tanaka M, Yoshimura Y. 1997. Integrins and reproductive physiology: Expression and modulation in fertilization, embryogenesis, and implantation. Fertil Steril 67: 799-811.
28. Tarantal AF, Hendrickx AG. 1988. Characterization of prenatal growth and development in the crab-eating macaque (Macaca faslcularls) by ultra sound. Anat Rec 222:177-184.
29. TYSABRI (natalizumab) [prescribing information!. South San Francisco, CA: Elan Pharmaceuticals, Inc.; 2008, available at www.tysabri.com.
30. Wehner NG, Skov S, Shopp G, Rocca MS. 2009a. Effects of natalizumab, an α4 integrin inhibitor, on fertility in male and female guinea pigs. Birth Defects Res B Dev Reprod Toxicol 86:108-116.
31. Wehner NG, Shopp G, Oneda S. 2009b. Embryo/Fetal development in cynomolgus monkeys exposed to natalizumab, an α4 integrin inhibitor. Birth Defects Res B Dev Reprod Toxicol 86:117-130.
32. Wehner NG, Shopp G, Osterburg I, Fuchs A, Buse E, Clarke J. 2009c. Postnatal development in cynomolgus monkeys following prenatal exposure to natalizumab, an a4 integrin inhibitor. Birth Defects Res B Dev Reprod Toxicol 86:144-156.
33. Yang JT, Rayburn H, Hynes RO. 1995. Cell adhesion events mediated by α4 integrins are essential in placental and cardiac development. Development 121:549-560.