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

Abstract

Abstract 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.