Kagocel in the therapy of influenza and acute respiratory viral infections: Data analysis and systematization from the results of preclinical and clinical trials

Сологуб, Т. В.; Tsvetkov, V. V

doi:10.17116/terarkh2017898113-119

Cited by 13 publications

(6 citation statements)

References 7 publications

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“…This method ensures reliable detection of free gossypol impurity with high accuracy and precision at minimum amounts starting from 1.56•10-5 mg/mL. The specified method sensitivity is in line with the international publications on HPLC assay of gossypol (11,23). It should be mentioned that the method validation demonstrated that whole gossypol amount added to the substance from outside is reliably and accurately identified in this complex evidencing lack of nonspecific sorption of its free molecules on polymeric matrix.…”

Section: Manufacturing Quality Controlsupporting

confidence: 62%

“…Acute toxicity study allows to determine tolerable, toxic and lethal doses of test product administered inragastrically, establish the causes of animal mortality during 14-day follow-up period, investigate its effect on general condition and a number of functional and morphological parameters. It should be noted that intoxication signs in acute toxicity study of free gossypol has been investigated thoroughly including respiratory distress, body weight changes, anorexia, weakness, apathy, signs of cardiac failure and death several days later (11). At that, the data from acute toxicity study of Kagocel revealed no animal mortality and no signs of acute intoxication were detected either.…”

Section: Preclinical Studiesmentioning

confidence: 99%

“…Numerous multinational studies demonstrated that gossypol produces antitumour, antioxidant and immunomodulating effect. (8)(9)(10)(11). However, it should be noted that gossypol use as a medicinal product is limited by low therapeutic breadth of the doses applied, especially systemic ones.…”

Section: Historymentioning

confidence: 99%

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Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Borovskaya

2018

Serbian Journal of Experimental and Clinical Research

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Antiviral drug Kagocel is widely used in Russia for prevention and treatment of acute respiratory infection, influenza, and herpes. The drug belongs to the group of interferon inductors. The article contains the review and analytical evaluation of safety of antiviral drug Kagocel. Kagocel is registered in the Russian Federation and some CIS countries and refers to the group of interferon inducers. This is a chemical compound of carboxymethyl cellulose and low-molecular natural polyphenol gossypol common in cotton-plant (Gossypium spp.) which protects the plant from depredators and diseases. Authors pay a special attention to the analysis and generalization of data from preclinical and clinical studies including the control of related substances. Absence of free gossypol impurities guaranteed by highly sensitive and specific quality control methods. Preclinical studies data was analyzed and the results were presented with focus on reproductive safety of Kagocel® in immature and mature animals.. No negative effect on animals’ reproductive function was revealed including spermatogenesis and generative function. No long-term product effect on reproductive system or next generations of animals was recorded both at therapeutic doses and at doses 10 times their exceeding. The safety of the drug demonstrated on data obtained from numerous clinical trials, including those involving children aged 2 years and older. Th is confirms the safety of antiviral drug Kagocel usage in clinical practice, including pediatrics.

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Section: Manufacturing Quality Controlsupporting

confidence: 62%

Section: Preclinical Studiesmentioning

confidence: 99%

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Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Borovskaya

2018

Serbian Journal of Experimental and Clinical Research

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“…Respiratory tract infections may be caused by bacteria, viruses and parasites (4)(5)(6), although viruses are thought to be responsible for the majority (approximately 20-60%) of these infections (7)(8)(9). Viral agents that are mostly involved include the respiratory syncytial virus (RSV), influenza A/B, rhinovirus, adenovirus, Eppstein-Barr virus (EBV) and cytomegalovirus (CMV), while the most common atypical agents are Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae (M pneumoniae), Chlamydophila pneumoniae (C pneumoniae), and Legionella pneumophila (10)(11)(12)(13). Also, several Herpes viruses such as Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2) and Human Herpesvirus 6 (HHV6) have been reported to be potentially associated with acute RTIs (14,15).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Viral and Atypical Bacterial Agents Using Polymerase Chain Reaction in Patients Presenting with Signs of Acute Respiratory Tract Infection

Ünver¹,

Karakeçili²,

Çıkman³

2018

West Indian Med J

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Objective:To assess viral and atypical bacterial agents using polymerase chain reaction in patients presenting with signs of acute respiratory tract infection (RTI) to Erzincan Mengucek Gazi Education and Research Hospital, Turkey. Methods: Viral and atypical bacterial agents were explored in patients presenting with RTI between February 1 and June 1, 2017. Genomic isolation was performed using a SolMag ® 12 fully-automated nucleic acid isolation system and SolMag ® Virus Nucleic Acid Isolation Kit. Amplifications were performed using a SmartCycler-II thermocycler (Cepheid) device in accordance with the instructions provided by the manufacturer. Results: Of the 120 patients, 44 (36.6%) were found to have at least one agent. Polymerase chain reaction detected influenza viruses in 28 patients, respiratory syncytial virus in seven, cytomegalovirus (CMV) in six, Herpes simplex virus 1 (HSV1) in two, Chlamydophila pneumonia in two, Human Herpesvirus 6 in one, and Herpes simplex virus 2 in one. Also, coexistent HSV1 and CMV positivity was found in two cases. One patient had positivity in both influenza A and CMV. Among atypical bacterial agents, only two patients were found to have Chlamydophila pneumonia. There was at least one comorbid condition in 48 patients (40%). Of these subjects in whom an agent could be identified, 21 were found to have co-morbidity, while 23 were free of comorbid conditions. Antibiotherapy had been started in 109 (90.8%) of the patients after initial assessment. Sixty-four patients were admitted, and two patients died. Conclusion: Polymerase chain reaction allowed rapid detection of agents responsible for acute RTIs. We believe that this technique may contribute to appropriate use of antibiotics in patients diagnosed with atypical bacterial infection and may prevent unnecessary antibiotherapy in infections caused by viral agents. Evaluación de agentes bacterianos atípicos y agentes virales utilizando la reacción en cadena de la polimerasa en pacientes que se presentan con signos de infección aguda de las vías respiratoriasRESUMEN Objetivo: Evaluar los agentes bacterianos atípicos y los agentes virales utilizando la reacción en cadena de la polimerasa en pacientes que acuden con signos de infección aguda de las vías respiratorias (IVR) al Hospital de Docencia e Investigación Erzincan Mengucek Gazi, Turquía. Métodos: Se exploraron agentes bacterianos atípicos y agentes virales en pacientes que acudieron con IVR entre el 1 de febrero y 1 de junio de 2017. El aislamiento genómico se realizó con un sistema SolMag ® 12 de aislamiento de ácido nucleico totalmente automatizado y un Kit SolMag ® de aislamiento de ácido nucleico viral. Las amplificaciones se realizaron utilizando un aparato termociclador SmartCycler-II (Cepheid) de acuerdo con las instrucciones proporcionadas por el fabricante. Resultados: De los 120 pacientes, se determinó que 44 (36.6%) tenían al menos un agente. La reacción en cadena de la polimerasa detectó virus de la influenza en 28 pacientes, virus sincitial respiratorio en ...

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“…Карбоксиметилцеллюлоза снижает токсичность госсипола и обеспечивает мембранный контакт препарата с клеточной поверхностью. В клинических исследованиях была подтверждена безопасность препарата Кагоцел ® ; в настоящее время он широко применяется в России для профилактики и лечения респираторных вирусных инфекций и герпеса [4,5].…”

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The effect of Kagocel® on gene expression of Toll-like receptors of innate immunity in THP-1 human monocytes with different levels of differentiation

Соколова¹,

Полосков²

2021

Biological Products. Prevention, Diagnosis, Treatment

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Kagocel® is used in Russia for the treatment of viral infections. In terms of its chemical structure, Kagocel® active ingredient is a copolymer of gossypol polyphenol and carboxymethylcellulose. The study investigated antiviral and cytokine-inducing activity of Kagocel®, as well as its toxic effects. The aim of the study was to investigate the effect of Kagoce ® active ingredient on the induction of expression of the innate immune system receptor genes (Toll-like receptors, TLR) in the THP-1 human acute monocytic leukemia cell line with different levels of differentiation. Materials and methods: the effect of Kagocel active ingredient was investigated at the concentrations of 0.2 and 2 mg/mL in the THP-1 human acute monocytic leukemia cell line with different levels of differentiation: non-differentiated monocytes, and monocytes differentiated into macrophage-like cells. Comparative analysis of the activity of TLR 2, 3, 4, 7, 8, 9 genes was carried out by quantitative RT-PCR. The study determined standard deviations of the levels of gene expression in the experimental cells (2deltaCq ± SD) relative to the expression in the control cells. Results: Kagocel active ingredient at the concentration of 0.2 mg/mL induced activation of TLR2 expression in THP-1 monocytes by 3.5 times, TLR3 by 2 times, TLR4 by 1.6 times, and at the concentration of 2 mg/mL also induced activation of TLR7 and TLR8 by 1.4 times, and TLR9 by 2 times. The levels of TLR2, TLR3, TLR9 induction were significantly higher in THP-1 monocytes partially differentiated into macrophage-like cells, and the highest stimulation level was observed for TLR2 (8 times). Conclusions: the results obtained characterise Kagocel® as a stimulator of TLR genes in the THP-1 cell line. The number of TLR genes induced in THP-1 monocytes was shown to increase with the increase in the product concentration. THP-1 monocyte differentiation into macrophage-like cells enhances susceptibility to Kagocel®. The positive regulation of TLR genes activity may account for antiviral and interferon-inducing properties of Kagocel®, and also suggests the possibility of expanding the use of the product for various immune-associated diseases.

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Kagocel in the therapy of influenza and acute respiratory viral infections: Data analysis and systematization from the results of preclinical and clinical trials

Cited by 13 publications

References 7 publications

Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Assessment of Viral and Atypical Bacterial Agents Using Polymerase Chain Reaction in Patients Presenting with Signs of Acute Respiratory Tract Infection

The effect of Kagocel® on gene expression of Toll-like receptors of innate immunity in THP-1 human monocytes with different levels of differentiation

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