| Literature DB >> 25530039 |
E Destexhe1, D Stannard2, O K Wilby2, E Grosdidier3, N Baudson1, R Forster3, C M Gérard1, N Garçon4, L Segal5.
Abstract
We assessed potential toxic effects of the MAGE-A3 Cancer Immunotherapeutic on female fertility and embryo-fetal, pre- and post-natal development in rats and on male fertility in rats and monkeys. Three groups of 48 female (Study 1) or 22 male (Study 2) CD rats received 5 or 3 injections of 100μL of saline, AS15 immunostimulant, or MAGE-A3 Cancer Immunotherapeutic (MAGE-A3 recombinant protein combined with AS15) at various timepoints pre- or post-mating. Male Cynomolgus monkeys (Study 3) received 8 injections of 500μL of saline (n=2) or the MAGE-A3 Cancer Immunotherapeutic (n=6) every 2 weeks. Rats were sacrificed on gestation day 20 or lactation day 25 (Study 1) or 9 weeks after first injection (Study 2) and monkeys, 3 days or 8 weeks after last injection. Injections were well tolerated. Female rat mating performance or fertility, pre- and post-natal survival, offspring development up to 25 days of age, and male mating performance (rats) or fertility parameters (rats and monkeys) were unaffected.Entities:
Keywords: Cancer immunotherapy; Immunostimulant; Monkey; Rat; Reproductive toxicity
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Year: 2014 PMID： 25530039 DOI： 10.1016/j.reprotox.2014.12.009
Source DB: PubMed Journal: Reprod Toxicol ISSN： 0890-6238 Impact factor: 3.143