Polyoxidonium (azoximer bromide) / NPO Petrovax - LARVOL DELTA

Targeted Restoration of T-Cell Subsets by a Fluorinated Piperazine Derivative β-Cyclodextrin Complex in Experimental Pulmonary Inflammation. (PubMed, Molecules) - "This study evaluates the immunomodulatory potential of a novel fluorinated piperazine-based aminophosphonate, complexed with β-cyclodextrin ((o-Fph)PPhβCD), comparing it with the clinically approved agent Polyoxidonium (PO) in a rat model of oleic acid-induced acute pneumonia...Structural confirmation of the inclusion complex was achieved through IR and NMR spectroscopy. These findings highlight (o-Fph)PPhβCD as a promising immunotherapeutic candidate that is capable of rebalancing immune cell populations and supporting host defense mechanisms during acute pulmonary inflammation."

Journal • Immunology • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • CD4 • FOXP3 • IL2RA • ISG20

Clinical status and cytokine profiles in patients with asthma or chronic obstructive pulmonary disease vaccinated against influenza. (PubMed, PLoS One) - "Analysis of the immunological, clinical and functional parameters in asthma and COPD patients showed that vaccination not only reduces the risk of influenza and other respiratory infections due to activation of non-specific protection, but also improves the clinical course of asthma and COPD."

Biomarker • Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases • CRP • IL10 • IL17A • IL2 • IL6

Immunomodulatory therapy in the postoperative period in chronic purulent otitis media (PubMed, Vestn Otorinolaringol) - "The results of evaluation of immunotropic action of this drug, as well as the clinical effect of its use allow to recommend azoximera bromide as an additional means in postoperative treatment and management of patients with CPOM."

Journal • Inflammation • Otorhinolaryngology • CD4 • CD8 • CRP • IFNG • IL10 • IL1B • TNFA

Comparison of Post-Vaccination Cellular Immune Response in Patients with Common Variable Immune Deficiency. (PubMed, Vaccines (Basel)) - "This study marks the first instance of using a simultaneous two-dose vaccination, which is associated with an elevated level of TLR expression in the immune cells. Administration of the adjuvanted vaccines in CVID patients appears promising. Further research into their impact on innate immunity and the development of more effective vaccination regimens is warranted."

IO biomarker • Journal • Infectious Disease • Influenza • Primary Immunodeficiency • Respiratory Diseases • TLR3 • TLR9

Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 (clinicaltrials.gov) - P2/3 | N=394 | Completed | Sponsor: NPO Petrovax | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A comparative study of the effectiveness of azoximer bromide and surgery on the quality of the life of patients with chronic rhinosinusitis without nasal polyps (PubMed, Vestn Otorinolaringol) - "Azoximer bromide treatment and surgery improve the quality of life of patients with CRS (according to the visual analog scale and all SNOT-22 domains) during a control survey after 3 months (p<0.001). Surgical treatment has a stronger impact on the quality of life, which is more noticeable in the influence on the domains "Rhinological symptoms", "Extranasal symptoms", "Ear/facial symptoms" (p<0.05). According to the domains "Psychological dysfunction", "Sleep dysfunction", surgical intervention had no advantages in affecting the quality of life, compared with taking azoximer bromide (p<0.05)."

Clinical • Journal • Surgery • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

THE ROLE OF IMMUNOCORRECTION IN THE TREATMENT OF PATIENTS CHRONIC PYELONEPHRITIS (ERA-EDTA 2024) - "The third group of 15 pregnant women with CP - with traditional therapy received ozone therapy and immune-regulating therapy with polyoxidonium... Along with the improvement of clinical and laboratory data in CP normalization of cellular and humoral immunity indicators was noted in pregnant women. Additional assignment to traditional therapy for chronic pyelonephritis of pregnant women, ozone therapy and therapy for correction of the immune system is a more effective treatment method."

Clinical • Back Pain • Musculoskeletal Pain • Nephrology • Pain • CD4 • CD8

Azoximer bromide and hydroxyapatite: promising immune adjuvants in cancer. (PubMed, Cancer Biol Med) - "AZB, an original immune modulator derived from a class of heterochain aliphatic polyamines that is licensed in Russia, the Commonwealth of Independent States, and Slovakia for infectious and inflammatory diseases, is and now being developed for use in cancer with promising results. These two immune adjuvants can be combined in various immunotherapy strategies."

Journal • Review • Hematological Malignancies • Lymphoma • Oncology

Potential of azoximere bromide for treatment of patients with acute inflammatory and infectious upper respiratory diseases (PubMed, Ter Arkh) - "Treatment with Polyoxidonium® contributes to achieving favorable outcomes in patients with inflammatory and infectious upper respiratory diseases. The study drug has a high safety profile."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Expression of Toll-like Receptors on the Immune Cells in Patients with Common Variable Immune Deficiency after Different Schemes of Influenza Vaccination. (PubMed, Viruses) - "in CVID patients, the use of adjuvanted vaccines is promising, and research on the influence of the innate immunity and more effective regimens should be continued."

Immune cell • IO biomarker • Journal • Infectious Disease • Influenza • Primary Immunodeficiency • Respiratory Diseases • TLR3 • TLR8 • TLR9

Use of immunomodulatory therapy as part of comprehensive treatment of non-severe community-acquired pneumonia and its long-term results. (PubMed, Drugs Context) - "Group 1 (control) received only standard CAP therapy; the other two groups received immunomodulators simultaneously with the standard therapy: bacterial lysate for group 2 and azoximer bromide (AzB) for group 3...In 2 years of follow-up, the long-term effects of the immunomodulatory therapy showed a statistically significant lower incidence of LRTIs in the AzB group only. However, given the small sample size of this study, further clinical studies are needed."

Immunomodulating • Journal • Infectious Disease • Pneumonia • Respiratory Diseases • IL6

Effect of Influenza Immunization With Inactivated Trivalent Polymer-subunit Vaccine in Lung Transplant Recipients (ATS 2023) - "Patients received immunosuppressive therapy, that included calcineurin inhibitors, antimetabolites (mycophenolate mofetil), and systemic glucocorticosteroids.For vaccination, an inactivated polymer-subunit vaccine "Grippol@plus" (Petrovax Pharm LLC) was used, which contains in one dose (0.5 ml) hemagglutinins of 3 strains of the influenza virus in amount of 5 μg of each hemagglutinin and 500 μg of the immunoadjuvant azoximer bromide. Influenza vaccination of lung transplant recipients with inactivated polymer-subunit vaccine with reduced amount of antigens is safe and induces high levels of seroprotection."

Clinical • Immunology • Infectious Disease • Influenza • Respiratory Diseases • Transplant Rejection • Transplantation

Polymeric Approach to Adjuvant System in Antibody Production against Leishmaniasis Based on Hybridoma Technology. (PubMed, Iran J Parasitol) - "Accordingly, Freund's adjuvant (1956, M. tuberculosis), as a classic adjuvant in studies, was used comparatively with the non-toxic polymeric based Polyoxidonium adjuvant...Adjuvant selection is very important in terms of the specificity of antibody responses of cells produced in hybridoma technology. Therefore, PO is recommended as a new adjuvant system in this study."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. (PubMed, F1000Res) - "Meta‑regression analysis revealed that AZB did not contribute to vaccine reactogenicity. Post-vaccination geometric mean titres in those exposed to AZB-adjuvanted vaccine and comparator vaccine treatment arms were similar in both children and adults aged 18-60 years, implying an antigen-sparing effect by AZB."

Review • Infectious Disease • Influenza • Respiratory Diseases

Open-label use of an aliphatic polyamine immunomodulator in patients hospitalized with COVID-19. (PubMed, Drugs Context) - "Azoximer bromide (AZB; Polyoxidonium) is an immunomodulating molecule frequently used in the Russian Federation...AZB combined with standard of care was safe and well tolerated. An apparent clinical improvement could not be fully evaluated due to the lack of a direct control group; further assessment of AZB for the treatment of COVID-19 in a randomized, placebo-controlled study is warranted."

Journal • Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Azoximer Bromide: Mystery, Serendipity, and Promise. (PubMed, Front Oncol) - "This literature review analyses the novel mechanisms that mediate the AZB direct anticancer effects. Overall, the evidence suggests that AZB has the hallmark of an agent that could be used to support existing cancer treatments at different stages of disease."

Journal • Review • Immune Modulation • Immunology • Infectious Disease • Inflammation • Oncology

[VIRTUAL] Impact of the azoximer bromide concomitant therapy on outcomes in patients with soft tissue sarcoma. (ASCO 2021) - "Use of AB with standard therapy in STS emerged as an independent favorable prognostic factor . Appropriately controlled, well-designed prospective trials are needed to investigate this finding further."

Clinical • Immune Modulation • Immunology • Inflammation • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

[VIRTUAL] Impact of the azoximer bromide concomitant therapy on patient outcomes in patients with melanoma. (ASCO 2021) - "The addition of AB to standard therapy in melanoma appears to be an independent favorable prognostic factor . Prospective, randomized, clinical trials are needed to investigate these findings further."

Clinical • IO biomarker • Immune Modulation • Immunology • Inflammation • Melanoma • Oncology • Solid Tumor • BRAF

The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study. (PubMed, Drugs Context) - "AZB was safe and well tolerated when administered in addition to standard of care treatment for COVID-19. Further randomized, placebo-controlled studies are needed to elucidate any potential therapeutic effect in COVID-19."

Clinical • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP

Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 (clinicaltrials.gov) - P2/3; N=394; Active, not recruiting; Sponsor: NPO Petrovax; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P=N/A; N=81; Completed; Sponsor: NPO Petrovax; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

Polyoxidonium Activates Cytotoxic Lymphocyte Responses Through Dendritic Cell Maturation: Clinical Effects in Breast Cancer. (PubMed, Front Immunol) - "In summary, our in vitro results show that PO increases the number of costimulatory molecules on DC that prime T cells, favoring the production of effector T cells. This may support the future clinical development of PO in cancer treatment."

Clinical • IO Biomarker • Journal • Breast Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Triple Negative Breast Cancer

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency. (PubMed, Vaccines (Basel)) - "Adjuvant QIV promotes formation of specific immunity to vaccine strains, regardless of antibodies' presence or absence before. In CVID patients search of new regimens should be continued."

Clinical • Journal • Immunology • Infectious Disease • Primary Immunodeficiency

Assessment of Immunogenicity of Adjuvanted Quadrivalent Inactivated Influenza Vaccine in Healthy People and Patients With Common Variable Immune Deficiency. (PubMed, Front Immunol) - "Most patients with CVID showed an increase in post-vaccination antibody titer without reaching conditionally protective antibody levels. Immunization with single dose of adjuvanted QIV with decreased amount of hemagglutinin protein to all virus strains due to the use of azoximer bromide forms protective immunity in healthy people, but in patients with CVID the search for new vaccination schemes is the subject of further investigations, as well as the effectiveness of boosterization with adjuvant vaccines."

Clinical • Journal • Immunology • Infectious Disease • Primary Immunodeficiency

Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P; N=81; Active, not recruiting; Sponsor: NPO Petrovax

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease