Details

Autor(en) / Beteiligte

• Destexhe, E.
• Stannard, D.
• Wilby, O.K.
• Grosdidier, E.
• Baudson, N.
• Forster, R.
• Gérard, C.M.
• Garçon, N.
• Segal, L.

Titel

Nonclinical reproductive and developmental safety evaluation of the MAGE-A3 Cancer Immunotherapeutic, a therapeutic vaccine for cancer treatment

Ist Teil von

• Reproductive toxicology (Elmsford, N.Y.), 2015-01, Vol.51, p.90-105

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2015

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• •Evaluation of the potential toxic effects of the MAGE-A3 Cancer Immunotherapeutic.•Combination of a cancer-specific antigen (MAGE-A3) with an immunostimulant (AS15).•Male mating performance (rats) or fertility (rats and monkeys) were unaffected.•Embryo-fetal or offspring development (rats) were not affected by treatment.•Repeated injections of MAGE-A3 in animals did not indicate reproductive toxicity. 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.