PRECLINICAL STUDY OF GENERAL TOXICITY OF ADELACTTМ IN RODENT MODELS
Abstract
Toxicity of AdeLact™, a novel medicinal product on the basis of recombinant pseudo-adenoviral particles expressing human lactoferrin gene, was studied. Acute toxicity was evaluated in mice and rats, and sub-chronic toxicity was evaluated in rats and rabbits. According to its acute toxicity, AdeLact™ was classified as a low hazardous preparation and according to its sub-chronic toxicity, as a moderate hazardous preparation. In toxic doses, AdeLact™demonstrated moderate hepatic and renotropic toxicity. Inflammatory processes might develop in lungs after administration of AdeLact™. Intravenous infusion of AdeLact™ produces a mild and fully recoverable local effect.
About the Authors
Raisa Ivanovna YakubovskayaRussian Federation
Andrey Alexandrovich Pankratov
Russian Federation
Tatyana Nikolaevna Andreeva
Russian Federation
Julia Borisovna Venediktova
Russian Federation
Olga Alexeevna Bezborodova
Russian Federation
Irina Leonidovna Tutykhina
Russian Federation
Evgeniy Valer’evich Evgrafov
Russian Federation
Denis Yur’evich Logunov
Russian Federation
Maxim Mihailovich Shmarov
Russian Federation
References
1. Gonzalez-Chavez SA, Arevalo-Gallegos S, Rascon-Cruz Q. Int J Antimicrob Agents. 2009. V. 33. N4. P. 301e1-8.
2. Nemtsova E.R., Edeleva N.V., Osipova N.A., Yakubovskaya R.I., Boiko A.V., Demidova L.V., Chissov V.I. Russian Journal of Oncology. 2006. # 4. P. 29-33 (in Russian).
3. Chissov V.I., Yakubovskaya R.I., Nemtsova E.R., Osipova N.A., Edeleva N.V., Utkin M.M., Zvyagin A.A. Khirurgiya. Zhurnal imeni N.I. Pirogova ( Surgery) . 2008. #11. P. 14-19 (in Russian).
4. Naroditskiy B.S., Shmarov MM, Logunov DYu, Tutykhina IL, Tokarskaya EA, Chissov VI, Yakubovskaya RI, Nemtsova ER, Bezborodova OA. Method for Production of Recombinant Human Lactoferrin. Russian Patent # 2340676, 2008 (in Russian).
5. Tutykhina I., Bezborodova O., Shmarov M, Logunov D., Nemtsova E., Yakubovskaya R., Naroditskiy B., Gintsburg A. Protein expression purification. 2009. V. 65. N1. P. 100-107.
6. Tutykhina I.L., Bezborodova O.A., Verkhovskaya L.V., Shmarov M.M., Logunov D.Yu., Nemtsova E.R., Naroditskiy B.S., Yakubovskaya R.I., Ginzburg A.L. Molecular Genetics, Microbiology & Virology. 2009. V. 1. P. 27-31 (in Russian).
7. Yakubovskaya R.I., Bezborodova OA, Nemtsova ER, Tutykhina IL, Shmarov MM, Logunov DYu, Naroditskiy BS, Chissov VI, Ginzburg AL. Molecular Genetics, Microbiology & Virology. 2010. V. 2. P. 28-33 (in Russian).
8. Guidelines for Experimental (Preclinical) Study of Novel Pharmacological Substances. Edit. RU Khabriev, М, «Medicine», 2005, 832 p (in Russian).
9. Methods of Experimental Chemotherapy, Practical Guidelines. Edit. GN Pershin, М. «Medicine», 1971, 541 p (in Russian).
Review
For citations:
Yakubovskaya R.I., Pankratov A.A., Andreeva T.N., Venediktova J.B., Bezborodova O.A., Tutykhina I.L., Evgrafov E.V., Logunov D.Yu., Shmarov M.M. PRECLINICAL STUDY OF GENERAL TOXICITY OF ADELACTTМ IN RODENT MODELS. Toxicological Review. 2015;(2):18-25. (In Russ.)