The international clinical trial of Polyoxidonium completes recruiting COVID-19 patients

In early February, Petrovax successfully completed the recruitment of patients for an international multicenter clinical trial (IMCT) of the original Russian Polyoxidonium medicine for the treatment of moderate and severe cases of COVID-19. The study took in a total of 394 patients from Russia and Slovakia.

The multicenter clinical trial of Polyoxidonium is carried out in accordance with the WHO Protocol, which is the recognized gold standard for conducting clinical trials. This is the only original Russian medicine approved by EU regulators, and the first Russian drug that received approval in March 2020 from the Ministry of Health of the Russian Federation for IMCT in the treatment of patients with coronavirus infection.

The research results are expected in the summer of 2021. If the study gives positive results, the original Russian product can claim a unique status as a medicine against COVID-19 with proven efficacy in IMCI.

Polyoxidonium has already been successfully used to fight the virus both in Russia and the EU. It is used for the preventive protection of doctors1 working in the “red zones”, and is also being studied in open observation programs in patients with COVID-192 . Slovakia has included the medicine in the country's clinical guidelines for treating patients with coronavirus infection3.

Petrovax supplied 5 thousand packages of Polyoxidonium tablets to the Louis Pasteur University Hospital (Slovakia) for the prevention and treatment of coronavirus infection within state health insurance program. The delivery was done on the grounds of a special permit issued by the Ministry of Health of Slovakia in 2021. According to the document, the therapeutic use of the medicine is allowed in medical institutions around Slovakia for the purpose of immunoprophylaxis of coronavirus infection in medical workers and treatment of patients with COVID-19. As part of a social initiative in 2020, Petrovax handed over more than 20,000 packages of Polyoxidonium to Russian doctors working in the “red zones” to prevent coronavirus infection

President of Petrovax Mikhail Tsyferov: “We have always held the potential of our original medicine products in high regard, so in 2020 we decided to launch a major research program about the possibilities of using Polyoxidonium against COVID-19. The start of an international study is a logical continuation of our strategy of developing a medicine at the international level according to the highest evidence standards. The research involves leading experts from around the world and we are developing partnerships with dozens of foreign scientific laboratories and institutes. We hope that the successful completion of the IMCT will open a new chapter in the history of Polyoxidonium, help in the fight against coronavirus infection and open up new prospects for Russian products on the global market.”

About the study

The international multicenter clinical trial of Polyoxidonium (Azoximer bromide) was launched by Petrovax in April 20204. The main objective of the study is to assess the efficacy and safety of the drug in adult patients hospitalized with COVID-19 and aged from 18 to 85 years.

July 2020 saw the completion of the first of two stages of the international clinical trial of Polyoxidonium, confirming the high safety profile of the drug in the treatment of patients with COVID-19. Based on the results of the first stage , an Independent International Data and Safety Monitoring Board (DMSB5 ), consisting of Russian and European experts, recommended to expand the number of participants and add patients with severe course of the coronavirus infection to the study group. Slovakia joined the international study last November.

About Polyoxidonium®

Polyoxidonium® (active ingredient – azoximer bromide) is an original Russian medication, which has been widely used in Russian clinical practice and exported to foreign countries for over 20 years. The medication has been registered and being supplied to 10 countries.

Polyoxidonium® is used in adults and children (6 months and older) to treat and prevent inflammatory infections (viral, bacterial and mycetogenetic) in exacerbation and remission phases. The mechanism of this medication is focused on the immune system. Polyoxidonium® increases the resistance to local and generalized viral infections.

The medication effectiveness and safety were proved by many clinical trials in various therapeutic fields6. The company is actively expanding the evidence base for the medication:

  • Papers dealing with its in vitro mechanism are published in international journals7,8,
  • The medication has double-blind placebo-controlled trials for flu and ARVI treatment9.
  • In 2019, one of Russian journals published the meta analysis of clinical trials of Polyoxidonium® effectiveness for treatment of inflammatory infections of respiratory organs in children and adolescents10.
  • In 2017, Petrovax received a report about the successful results of post-authorization safety study (PASS) of Polyoxidonium® in the EU (Slovakia)11, 12.
  • The medication is registered in Europe (Slovakia) and complies with all the EU regulatory requirements.

In general, there are over 350 academic papers published about Polyoxidonium13, including those based on independent studies: References to scientific publications:

1 - "Experience with prevention of the new coronavirus infection (COVID-19) among medical workers", V.P. Vavilova, A.M. Vavilov, N.K. Perevoshchikova, S.A. Tsarkova, O. I. Pivovar, I.I. Klimova, the Therapy Journal, RNMOT, No. 6/2020 https://therapy-journal.ru/ru/archive/article/39449

2 - Mukhamadieva L.R., Mavzyutova G.A., Tyurina E.B., Kuzovkina O.Z. Possibilities of pathogenetic therapy of the new coronavirus infection. RMR Medical Review. 2020;4():1–7. DOI: 10.32364/2587-6821-2020-4--1-7 Possibilities of pathogenetic therapy of the new coronavirus infection | Mukhamadieva L.R., Mavzyutova G.A., Tyurina E.B., Kuzovkina O.Z. RMR No.4 dated 09.16.2020

3 - https://standardnepostupy.sk/_files/200000421-45c4245c44/COVID-19%20hospitalizovan%C3%AD%20pacientiv%20nad%2065%20rokov%20-%20lie%C4%8Dba%20-%20infekcne%20oddelenia%20verzia%202.0.pdf

4 - http://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=daba6b25-ac75-4bd4-9f67-a800651502e6&CIPermGUID=1D24A86C-2196-46DD-86C1-C5B5C6AD0F8E

5 - DSMB – Data and Safety Monitoring Board, an independent committee to monitor the data on effectiveness and safety of clinical trials.

6 - https://polyoxidonium.ru/for-specialists/publication/

7 - Dyakonova V. A. et al. Study of interaction between the polyoxidonium immunomodulator and the human immune system cells //International immunopharmacology. – 2004. – V. 4. – No. 13. – Pp. 1615-1623.

8 - Alexia C., CREN M. et al. Polyoxidinium® activates cytotoxic lymphocyte responses through Dendritic Cell maturation: clinical effects in breast cancer // Frontiers in Immunology. – 2019. – V. 10. – P. 2693.

9 - Kharit S.M., Galustyan A. N. Azoximer bromide as a safe and effective medication for treatment of acute respiratory infections of upper airways in children: a review of results of double-blind placebo-controlled trials (Phase 2 and 3) // Pediatry. Supplement to Consilium Medicum. – 2017. – No. 2.

10 - Karaulov A.V., Gorelov A.V. Use of azoximer bromide in the therapy of inflammatory infections of respiratory organs in children: meta analysis of controlled clinical trials // Infectology Journal. – 2019. – V. 11. – No. 4. – Pp. 31-41.

11 - http://www.encepp.eu/encepp/viewResource.htm?id=19533

12 - Peter Pružinec, Natalia Chirun, Audrius Sveikata. The safety profile of Polyoxidonium in daily practice: results from postauthorization safety study in Slovakia. // Immunotherapy. (2018) 10 (2), 1, pp 1 – 7.

12 - https://www.ncbi.nlm.nih.gov/pubmed/?term=polyoxidonium

13 - https://www.ncbi.nlm.nih.gov/pubmed?term=polyoxydonium&cmd=correctspelling

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