The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:
Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Participants in the experimental and control group will be:
Amsel criteria assessment
Colpotest-PH (vaginal acidity)
aminotest with 10% KOH solution ("fish odor")
microscopic examination of vaginal discharge
Bacteriologic culture of vaginal discharge
Polymerase chain reaction of epithelial cell scrapings from the vagina
electron microscopy of vaginal epithelial cell scrapings
Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Participants in the control group: Metronidazole.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.

Start Date01 Jun 2024

Sponsor / Collaborator

I.M. Sechenov First Moscow State Medical University

NCT06453200

/ RecruitingPhase 4IIT

Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Recurrent Bacterial Vaginosis.

Bacterial vaginosis (BV) occupies one of the leading places in the structure of the of gynecologic morbidity. This syndrome affects from 26 to 29% of women of reproductive age. Bacterial vaginosis is a non-inflammatory syndrome based on the replacement of normal lactoflora by opportunistic microorganisms. The modern concept of pathogenesis of bacterial vaginosis is the formation of biofilms, mainly Gardnerella vaginalis, on the surface of the vaginal epithelium. Associated with biofilms bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, ability to evade protective mechanisms and prolonged persistence in the vaginal environment, which is manifested by an increase in the rate of recurrent and chronic course.
In connection with the above described, it is relevant to study in vivo the role of drug action on biofilms in order to destroy them and, as a consequence, to increase the effectiveness of pathogenetic antibacterial therapy, reduce the frequency of BV recurrences and improve the quality of life of women. According to the local and international literature, there are various ways to affect biofilms, one of which is enzymatic destruction of the matrix. Bovgialuronidase azoximer was chosen as the study drug.

Start Date01 Jun 2024

Sponsor / Collaborator

I.M. Sechenov First Moscow State Medical University

NCT06568718

/ CompletedNot Applicable

A Multicenter, Randomized, Parallel, Controlled, Prospective, Open-label Study of the Efficacy and Safety of Longidaze Lyophilisate for Solution for Injections and Rectal Suppositories 3,000 IU in the Combined Treatment of Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is:
* Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score?
* What medical problems do participants have under the combined treatment by Longidaze and tamsulosin?
Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better.
Participants will:
* Take tamsulosin (0.4mg) every day for 130 days
* In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications)
* Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

Start Date20 Mar 2023

Sponsor / Collaborator

NPO Petrovax Pharm Ltd.

100 Clinical Results associated with Bovhyaluronidase azoximer

100 Translational Medicine associated with Bovhyaluronidase azoximer

100 Patents (Medical) associated with Bovhyaluronidase azoximer

Literatures (Medical) associated with Bovhyaluronidase azoximer

06 Mar 2025·S.S. Korsakov Journal of Neurology and Psychiatry

Sequential use of botulinum toxin A and bovhyaluronidase azoximer in the correction of post-stroke spasticity

Article

Author: Orlova, O.R. ; Valiev, V.K. ; Ivanov, D.O. ; Iakovleva, P.N. ; Akulov, M.A. ; Krasavina, D.A.

A clinical case of consistent use of botulinum toxin type A (BTA) and azoximer bovhialuronidase (BA) in a 69-year-old patient who suffered an ischemic stroke (II) with right-sided hemiparesis is presented. BTA (incobotulotoxin) was injected under ultrasound control (ultrasound) into the muscles of the target pathological patterns at a dose of 500 units. After 3 weeks, under the control of ultrasound navigation, BA was injected into the 2 most fibrotic shoulder muscles at a dose of 3.000 IU (1.500 IU each). The effectiveness of therapy was monitored using a modified Ashworth scale (MAS), goniometry, and electromyography. A decrease in the severity of the leading pattern of spasticity of the muscles of the upper extremity (on the MAS scale) after injection of BTA was found. After consistent application of BA, a distinct change in the structure of muscle tissue and a decrease in tone in spastic muscles were recorded. The results obtained confirm the safety of botulinum therapy and the good tolerability and efficacy of Xeomin in a patient with spasticity with contracture formation after AI. The introduction of ASTHMA after botulinum therapy makes it possible to increase the elasticity of spastic muscles by reducing the severity of fibrous changes and improving motor function.

19 Sep 2023·Life (Basel, Switzerland)

Anti-Inflammatory and Antifibrotic Potential of Longidaze in Bleomycin-Induced Pulmonary Fibrosis.

Article

Author: Kogai, Lena ; Pershina, Olga ; Ermakova, Natalia ; Bochkov, Pavel ; Pan, Edgar ; Pakhomova, Angelina ; Zhukova, Mariia ; Grimm, Wolf-Dieter ; Dagil, Yulia ; Avdeev, Sergey ; Sandrikina, Lubov

Idiopathic pulmonary fibrosis (IPF) is one of the most common forms of interstitial lung disease, characterized by progressive parenchymal fibrosis and respiratory failure. In a model of bleomycin-induced pulmonary fibrosis, the antifibrotic and anti-inflammatory activity of Longidaze (Bovhyaluronidase Azoxymer), which contains a conjugate of the hyaluronidase enzyme with a high molecular weight synthetic carrier azoxymer bromide, was investigated. Experiments were conducted in male C57BL/6 mice. Longidaze was administered at different doses by intranasal and intramuscular routes. Histology, hematology, and enzyme-linked immunosorbent assay were used in the study. The use of Longidaze reduced pulmonary fibrosis, as evidenced by an improvement in histopathologic damage to the lungs, a decrease in the area of connective tissue, and the levels of profibrotic factors (TGF-β1, hydroxyproline, collagen I) in lung tissue. In addition, Longidaze inhibited the inflammatory response in pulmonary fibrosis, and decreased the levels of IL-6, TNF-α, and hyaluronic acid in lung tissue and the recruitment of inflammatory cells into lung tissue. The highest therapeutic efficacy was observed with the use of Longidaze at doses of 120 and 1200 U/kg intramuscularly, which was superior to that of the reference drug pirfenidone axunio. The data presented in this study suggest that Longidaze is a new and promising drug for the treatment of IPF that warrants further investigation in patients with fibrotic interstitial lung disease.

30 Dec 2021·Urologiia

An observational randomized study of the efficacy and safety of the drug Longidase®, vaginal and rectal suppositories 3000 iu in the treatment of patients with symptoms of the lower urinary tract on the background of benign prostatic hyperplasia

Article

Author: Kuzmenko, V V ; Gyaurgiev, T A ; Kuzmenko, A V ; Vinnik, Yu Yu

INTRODUCTIONBenign prostatic hyperplasia (BPH) is among the most significant urological diseases, and improving the effectiveness of treatment of patients with this disease is one of the main tasks in modern urology. The aim of the study is to evaluate the effectiveness of Longidase in the treatment of men with benign prostatic hyperplasia.MATERIALS AND METHODSThe study included 120 patients with lower urinary tract symptoms caused by BPH, who were randomly assigned to 2 groups of 60 people. In the main group (MG), Longidaza 3000 ME therapy was performed in combination with tamsulosin. In the comparison group (CG), tamsulosin monotherapy was performed. The patients were examined during 5 visits for 162+/-3 days.RESULTSDuring the treatment period, compliance was 100%, all patients followed the doctors prescriptions, there were no cases of refusal of therapy. In addition, there were no cases of adverse events associated with taking the drug Longidaza. The examination initially revealed symptoms of the lower urinary tract in both groups against the background of prostatic hyperplasia, erectile dysfunction and a decrease in the quality of life. The therapy performed in both groups was effective, as evidenced by a decrease in the average score on the I-PSS scale, an increase in maximum urine flow rate, a decrease in volume of residual urine, which led to an improvement in the quality of life according to the QoL scale. Nevertheless, in the group of patients receiving Longidaza, after 50 days of therapy, there was a more pronounced positive dynamics of both the average score on the I-PSS and QoL scales, and the average maximum urine flow rate value according to the results of uroflowmetry. The differences between the groups according to these indicators were statistically significant (p<0.05). After 50 days of follow-up in GS, the average prostate volume did not change significantly, whereas in MG it decreased, and the differences between the groups were statistically significant (p=0.001). During subsequent visits, there was a tendency to decrease the size of the prostate in the MG, while in the CG there was a moderate increase in the volume of prostate according to ultrasound.CONCLUSIONThus, according to the results obtained in the course of this observational study, the drug Longidaza 3000 ME can be effectively used in patients with BPH, prevent the progression of the disease, contribute to the persistent relief of LUTS and improve the quality of life of patients in this category.

100 Deals associated with Bovhyaluronidase azoximer

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Scleroderma, Systemic	Russia	NPO Petrovax Pharm Ltd.	31 Dec 2005
Hyperplasia	Russia	NPO Petrovax Pharm Ltd.	01 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 3	Russia	NPO Petrovax Pharm Ltd.	08 Apr 2022
Lung Diseases, Interstitial	Phase 3	Russia	NPO Petrovax Pharm Ltd.	08 Apr 2022
Post Acute COVID 19 Syndrome	Phase 3	Russia	NPO Petrovax Pharm Ltd.	08 Apr 2022
Scleroderma, Systemic	Discovery	Europe	NPO Petrovax Pharm Ltd.	-

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