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Embryo-fetal loss data (EFL, between gestation day [GD] 20 and 140) and stillbirth (SB, after GD140) were compared in the Cynomolgus monkey model between our “old” historical control data, obtained from 18 pre- and post-natal developmental (PPND) studies (N=341 at GD20) conducted in 2005 – 2011, and currently on-going in-house (“new”) PPND study (N=11).

All maternal animals in the old data were single-housed and socially-housed (two animals in a four-pack caging unit) in the new data set. Total number of EFL was 18.2% (mean ±SD = 18.1 ±8.7%, Min to Max = 6.3 to 31.3%) in the old data and 9.1% in new data sets. Incidences in the first, second, and third trimesters (GD20 – 50, 51 – 100, 101 – 140) were 12.9, 2.9, and 2.3%, respectively, in old data set and 0.0, 0.0, and 9.1%, respectively, in new data set. Mean gestation length was 158 ±8 days in old data and 159 ±7 days in new data set.

Total number of SB was 14.7% (mean ±SD = 14.4 ±9.3%, Min to Max = 0.0 to 33.3%) in old data and 0/10 (0.0%) in new data sets. Total number of infant death at on or before Day 7 of post-birth was 4.8% (mean ±SD = 4.9 ±5.3%, Min to Max = 0.0 to 14.3%) in old data and 0/10 (0.0%) in new data sets.

Common clinical pathology data collected during the gestation period and during the first month post-delivery were also comparable between the two data sets. Although numbers of data points from socially-housed animals are still small at this point, EFD/SB data, and common clinical pathology parameters, obtained from socially-housed animals, were comparable with those obtained from single-housed animals. Therefore, we consider that both data sets can be combined and historical control data in PPND studies can be accumulated further despite variances in housing conditions.

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S. Oneda, N. Lalayeva, J. Reynolds, G. Von Scherr, M. Vegarra, T. Rogers.

SNBL USA, Ltd., Everett, WA, USA