Reprod Toxicol 2017 12 13;74:116-133. Epub 2017 Sep 13.
Toxicology, Research & Development, MedImmune Inc., One MedImmune Way, Gaithersburg, MD 20854, United States.
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Birth Defects Res B Dev Reprod Toxicol 2015 Jun 20;104(3):100-16. Epub 2015 Jul 20.
Charles River Laboratories, Reno, Nevada.
Tabalumab, a human IgG4 monoclonal antibody (mAb) with neutralizing activity against both soluble and membrane B-cell activating factor (BAFF), has been under development for the treatment of autoimmune diseases. The purpose of this study was to determine the potential adverse effects of maternal tabalumab exposure on pregnancy, parturition, and lactation of the mothers and on the growth, viability, and development of the offspring through postnatal day (PND) 204. Tabalumab was administered by subcutaneous injection to presumed pregnant cynomolgus monkeys (16-19 per group) every 2 weeks from gestation day (GD) 20 to 22 until parturition at doses of 0, 0. Read More
Birth Defects Res B Dev Reprod Toxicol 2012 Dec 4;95(6):431-43. Epub 2012 Dec 4.
Abbott Laboratories, Abbott Park, Illinois 60064, USA.
Background: ABT-874 is an anti-IL-12/23 monoclonal antibody that binds to the p40 subunit of human IL-12 and IL-23. As part of its preclinical safety assessment, studies were conducted to assess its potential effects on pre- and postnatal development in cynomolgus monkeys.
Methods: In the embryo-fetal development studies, ABT-874 was administered once weekly subcutaneously to adult female cynomolgus monkeys at doses of 0, 5, 25, or 100 mg/kg during gestation days (GD) 20 to 48. Read More
Toxicol Sci 2011 Jan 11;119(1):116-25. Epub 2010 Oct 11.
Safety Assessment, Genentech Inc., 1 DNA Way, South San Francisco, California 94080, USA.
Rituximab is a chimeric murine/human-engineered immunoglobulin (Ig) G1 anti-CD20 monoclonal antibody, selectively depleting CD20-expressing cells in peripheral blood and lymphoid tissues. As part of the rituximab registration-enabling program for rheumatoid arthritis, cynomolgus monkey embryo-fetal development and pre- and postnatal developmental toxicity studies were performed. In both studies, female cynomolgus monkeys were administered rituximab iv at doses of 0/0, 15/20, 37. Read More
J Immunotoxicol 2016 4;13(1):7-19. Epub 2015 Sep 4.
c Wierda Toxicology Consulting, Inc. , New Palestine , IN , USA.
The potential immunotoxicity of tabalumab was assessed as a component of standard pre-clinical toxicology studies in cynomolgus monkeys. To evaluate potential tabalumab-associated immunosuppression after antigen challenge, cynomolgus monkeys were administered placebo control or tabalumab in three immunotoxicological safety studies. Study 1, a 4-week pilot study, evaluated biweekly intravenous (IV) control, and 0. Read More