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PRECLINICAL STUDY OF GENERAL TOXICITY OF ADELACT 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 Yakubovskaya
Federal State Budgetary Institution «P.A. Gerzen Moscow Research Institute of Oncology», RF Ministry of Health
Russian Federation


Andrey Alexandrovich Pankratov
Federal State Budgetary Institution «P.A. Gerzen Moscow Research Institute of Oncology», RF Ministry of Health
Russian Federation


Tatyana Nikolaevna Andreeva
Federal State Budgetary Institution «P.A. Gerzen Moscow Research Institute of Oncology», RF Ministry of Health
Russian Federation


Julia Borisovna Venediktova
Federal State Budgetary Institution «P.A. Gerzen Moscow Research Institute of Oncology», RF Ministry of Health
Russian Federation


Olga Alexeevna Bezborodova
Federal State Budgetary Institution «P.A. Gerzen Moscow Research Institute of Oncology», RF Ministry of Health
Russian Federation


Irina Leonidovna Tutykhina
Federal State Budgetary Institution «N.F. Gamaleya Research Institute of Epidemiology and Microbiology», RF Ministry of Helath
Russian Federation


Evgeniy Valer’evich Evgrafov
Federal State Budgetary Institution «N.F. Gamaleya Research Institute of Epidemiology and Microbiology», RF Ministry of Helath
Russian Federation


Denis Yur’evich Logunov
Federal State Budgetary Institution «N.F. Gamaleya Research Institute of Epidemiology and Microbiology», RF Ministry of Helath
Russian Federation


Maxim Mihailovich Shmarov
Federal State Budgetary Institution «N.F. Gamaleya Research Institute of Epidemiology and Microbiology», RF Ministry of Helath
Russian Federation


References

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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 ADELACT IN RODENT MODELS. Toxicological Review. 2015;(2):18-25. (In Russ.)

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ISSN 0869-7922 (Print)
ISSN 3034-4611 (Online)