Safety of Biological Preparations and Small Molecules. Are There Any Differences?

Колбин, А. С.; Харчев, А. В.

doi:10.15690/pf.v10i3.693

Pediatr. farmakol.

2013

DOI: 10.15690/pf.v10i3.693

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Safety of Biological Preparations and Small Molecules. Are There Any Differences?

А. С. Колбин¹,

А. В. Харчев²

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2022

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References 31 publications

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Toxicity profile of the new compound XC221GI from pre-clinical studies

Sukhanova¹,

Проскурина²,

Jain³

et al. 2022

Epidemiology and Infectious Diseases

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The major feature of COVID-19 is intensive virus-induced inflammation in vital body organs and spatiotemporal dysregulation of pro- and anti-inflammatory cytokines and chemokines synthesis. All this leads to unpredicted clinical progression and high risk of "cytokine storm" development. The "cytokine storm" is the pathogenetic basis for further development of life-threatening complications. Thus, there is a huge need to select effective and safe approaches that allow to control virus-induced inflammation as a part of preventive anti-inflammatory therapy. This article presents toxicological characteristics of the original low-molecular compound XC221GI (1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazin-2,6-dione) from pre-clinical studies. The obtained results demonstrate that the XC221GI does not have any toxic effect in repeated long-term administration. The compound was well tolerated by all animals. The no-observed-adverse-effect level (NOAEL) was 30 mg/kg per day for dogs and 450 mg/kg per day for rats. There were no effects of XC221GI on blood count, hematopoiesis and hemostasis. As well as no cytotoxic, mutagenic, genotoxic, carcinogenic properties or anaphylactogenic and immunotoxic activity were revealed for XC221GI. All known data enable to classify XC221GI as a low toxic compound and consider its safety profile as reasonably favorable.

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Toxicity profile of the new compound XC221GI from pre-clinical studies

Sukhanova¹,

Проскурина²,

Jain³

et al. 2022

Epidemiology and Infectious Diseases

View full text Add to dashboard Cite

show abstract

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Safety of Biological Preparations and Small Molecules. Are There Any Differences?

Cited by 1 publication

References 31 publications

Toxicity profile of the new compound XC221GI from pre-clinical studies

Toxicity profile of the new compound XC221GI from pre-clinical studies

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