Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Efficacy and safety of the new drug against multiple sclerosis «PEGylated Interferon beta-1a Human» in monkeys compared with unmodified interferon beta-1a
Abstract
The article presents the results of studies on the safety and efficacy of long-acting drug for the treatment of multiple sclerosis on the basis of recombinant human interferon beta-1a «PEGylated interferon beta-1a Human» (PEG IFN beta-1a) in monkeys Macaca mulatta in subcutaneous and intramuscular injection. The following doses were used: the maximum tolerated dose - 3.0·106 IU/kg, the intermediate dose - 1.5·106 IU/kg and the minimum dose, which was equivalent to human therapeutic dose of unmodified interferon beta-1a - 0.3·106 IU/kg. Quantify the parameters of pharmacodynamics of the PEG IFN beta-1a after single subcutaneous and intramuscular administration of increasing doses of different groups of monkeys. Evaluated the level and nature of the pathological changes of internal organs (visceral systems) of experimental animals caused by repeated subcutaneous and intramuscular injections of PEG IFN-beta 1a. Based on these studies the drug PEG IFN beta-1a in rhesus monkeys indicated that the drug is efficient (both in single subcutaneous and intramuscular administration) and does not have toxic effects (both in multiple subcutaneous and intramuscular administration) when using a therapeutic dose 0.3·106 IU/kg.
