The Ministry of Health of the Russian Federation has approved a Phase III international, multicenter, placebo-controlled clinical trial of the Russian branded medicine Polyoxidonium® (INN: Azoximer bromide) to treat COVID-19.
On the back of the global COVID-19 pandemic, Petrovax is implementing a large-scale study program on Polyoxidonium® to treat this condition. The company has launched an international, multicenter, adaptive, randomized, double-blind, placebo-controlled, comparator clinical study of efficacy and safety of Polyoxidonium® 6 mg, powder for solution for injection, for the treatment of hospitalized COVID-19 patients in Russia.
Concurrently, a clinical trial application for Polyoxidonium® in COVID-19 patients is being reviewed by the French Ministry of Health. The filing in Slovakia is under preparation. Petrovax is also negotiating with regulators potential studies in other countries.
The multicenter Polyoxidonium® study is conducted in accordance with the WHO Protocol. In Russia, the study will embrace clinical sites in Moscow, Nizhny Novgorod, Orenburg, and Yaroslavl. It will assess the medicinal product’s efficacy and safety in adult COVID-19 patients (males and females) 18-85 years of age. At Stage 1 of the study, 100 patients will be enrolled. A total of 454 patients is expected to be included in Stages 1 and 2 of the study. Preliminary clinical results are expected in June.
The results from the studies of Polyoxidonium® use in patients with infectious diseases suggest that the product may potentially be efficacious for the treatment of SARS-CoV-2-infected patients. There is the first successful experience of Polyoxidonium® administration in COVID-19 patients in Slovakia. Based on that experience, the product has been entered into the national clinical guidelines for the treatment of COVID-19 patients. We are proud that our study is the first and so far the only international, double-blind, placebo-controlled, clinical trial of a Russian branded medicinal product to treat the novel coronavirus infection.”
Apart from the international, multicenter clinical trial, Polyoxidonium® is currently being used in routine clinical practice in COVID-19 patients in Russia, the CIS, and Slovakia, including within the framework of an observational study.
The company has also been donating Polyoxidonium® as a preventive agent for the staff of some clinical sites.
Polyoxidonium® (active pharmaceutical ingredient: Azoximer bromide) is a Russian branded medicinal product that has been widely used for 20+ years in clinical practice in Russia as well as exported to other countries. Presently, the product is authorized and is being used in 10 countries.
Polyoxidonium® is used both in adults and children older than 6 months of age for the treatment and prevention of inflammatory infections of viral, bacterial, and fungal origin at the stage of exacerbation and remission. The product’s mode of actions targets the immune system. Polyoxidonium® boosts the body resistance against local and generalized viral infections.
The product’s efficacy and safety have been confirmed in numerous clinical trials in a variety of therapeutic areas. The company continues extending the product’s evidence base:
• The product has been authorized in Europe (Slovakia) and complies with all applicable EU regulations.
Polyoxidonium® is manufactured full-cycle, including API synthesis, in accordance with GMP standards at Petrovax’s state-of-the-art facility in Moscow region.
1 Dyakonova V. A. et al. Study of interaction between the polyoxidonium immunomodulator and the human immune system cells //International immunopharmacology. – 2004. – Т. 4. – №. 13. – С. 1615-1623
2 Alexia C., CREN M. et al. Polyoxidinium® activates cytotoxic lymphocyte responses through Dendritic Cell maturation: clinical effects in breast cancer //Frontiers in Immunology. – 2019. – Т. 10. – С. 2693
4 Pružinec P., Chirun N., Sveikata A. The safety profile of Polyoxidonium in daily practice: results from postauthorization safety study in Slovakia //Immunotherapy. – 2018. – Т. 10. – №. 2. – С. 131-137