阿法链道酶生物类似药（Generium Pharma）(Dornase alfa biosimilar(Generium Pharmaceuticals)) - 药物靶点：DNase I_在研适应症：囊性纤维化_专利_临床

概要

基本信息

药物类型

生物类似药、酶

别名

Tigerase

靶点

DNase I

作用机制

DNase I刺激剂(脱氧核糖核酸酶1刺激剂)

治疗领域

遗传病与畸形消化系统疾病呼吸系统疾病+ [1]

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2019-03-05),

囊性纤维化

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 146838

当前序列信息引自: *****

关联

3

项与阿法链道酶生物类似药（Generium Pharma）相关的临床试验

NCT05139901 / Terminated临床4期IIT

Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy

COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.

开始日期2021-12-01

申办/合作机构

UMC Ljubljana

NCT04459325 / Completed临床3期

A Prospective Open-label Study of the Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.

开始日期2020-06-01

申办/合作机构

Generium ZAO

NCT04468100 / Completed临床3期

A Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic Fibrosis

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® compared Pulmozyme® in patients with Cystic Fibrosis

开始日期2017-08-30

申办/合作机构

Generium ZAO

100 项与阿法链道酶生物类似药（Generium Pharma）相关的临床结果

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100 项与阿法链道酶生物类似药（Generium Pharma）相关的转化医学

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100 项与阿法链道酶生物类似药（Generium Pharma）相关的专利（医药）

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4

项与阿法链道酶生物类似药（Generium Pharma）相关的文献（医药）

2024-08-01·Current drug delivery

The Effect of PEGylation on Drugs’ Pharmacokinetic Parameters; from Absorption to Excretion

Review

作者: Khajeei, Ali ; Gholikhani, Tooba ; Javadzadeh, Yousef ; Masoomzadeh, Salar

Abstract::

Until the drugs enter humans life, they may face problems in transportation, drug delivery, and metabolism. These problems can cause reducing drug’s therapeutic effect and even increase its side effects. Together, these cases can reduce the patient's compliance with the treatment and complicate the treatment process. Much work has been done to solve or at least reduce these problems. For example, using different forms of a single drug molecule (like Citalopram and Escitalopram); slight changes in the drug’s molecule like Meperidine and α-Prodine, and using carriers (like Tigerase®). PEGylation is a recently presented method that can use for many targets. Poly Ethylene Glycol or PEG is a polymer that can attach to drugs by using different methods and resulting sustained release, controlled metabolism, targeted delivery, and other cases. Although they will not necessarily lead to an increase in the effect of the drug, they will lead to the improvement of the treatment process in certain ways. In this article, the team of authors has tried to collect and carefully review the best cases based on the PEGylation of drugs that can help the readers of this article.

2023-01-01·Vestnik otorinolaringologii

[Possibilities of using recombinant human deoxyribonuclease I in otorhinolaryngology].

Article

作者: Svistushkin, V M ; Eremeeva, K V ; Mironova, A R ; Sobolev, V P ; Sinkov, E V

ANNOTATION:

Dornase alfa (Pulmozyme, Tigerase) is a purified solution of recombinant human DNase, clinically developed for the treatment of pulmonary diseases in patients with cystic fibrosis (CF). The action of the drug is aimed at destroying the viscous secretion, rich in DNA strands of neutrophils, through their fragmentation, the density of the secretion decreases, and the aeration of the lower respiratory tract improves. The similarity of pathological processes with the formation of viscous exudate on the surface of the mucous membrane in diseases of the upper respiratory tract and ear initiated studies on the use of Dornase alpha in otorhinolaryngology.

MATERIAL AND METHODS:

The analysis of materials of domestic and foreign authors on the effectiveness of the use of the drug Dornase alfa in otorhinolaryngology was carried out.

RESULTS:

The review included 132 patients (10 studies) in whom Dornase alfa was used to treat CF-associated nasal and paranasal sinus diseases. Analysis of the literature revealed only 3 studies, one of which consisted of two parts, examining the effect of Dornase alpha on middle ear exudate: two studies were demonstrated in an animal model; one - in vitro on samples of middle ear effusion which were aspirated through a myringotomy incision from patients with recurrent acute otitis media; and one in clinical 40 patients (40 ears) for hydrolysis of exudate in the tympanostomy tubes.

CONCLUSION:

Analysis of studies on the use of Dornase alfa demonstrates an improvement in clinical symptoms in all patients with CF and chronic rhinosinusitis. In experimental studies on an animal model, as well as in vitro research on exudate from the middle ear, Dornase alfa has demonstrated high efficacy and safety. Dornase alfa is a drug with high potential, further research is needed for wider use in ENT practice, especially in otiatrics.

PloS one3区 · 综合性期刊

Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100))

3区 · 综合性期刊

ArticleOA

作者: Revel-Muroz, Nataliya P ; Magnitskaya, Olga V ; Zilber, Ilya E ; Kashirskaya, Nataliya Yu ; Kozyreva, Liliya S ; Stepanenko, Tatiana A ; Ukhanova, Olga P ; Akhtyamova-Givirovskaya, Nina E ; Gapchenko, Elena V ; Seitova, Gulnara N ; Markova, Oksana A ; Krasovsky, Stanislav A ; Ponomareva, Natalya D ; Kudlay, Dmitry A ; Asherova, Irina K ; Reutskaya, Elena M ; Abdulganieva, Diana I ; Amelina, Elena L ; Kudelya, Lubov M

Background:

Patients with cystic fibrosis (CF) need costly medical care and adequate therapy with expensive medicinal products. Tigerase® is the first biosimilar of dornase alfa, developed by the lead Russian biotechnology company GENERIUM. The aim of the manuscript to present post hoc sub-analysis of patients’ data with cystic fibrosis and severe pulmonary impairment of a larger comparative study (phase III open label, prospective, multi-centre, randomized study (NCT04468100)) of a generic version of recombinant human DNase Tigerase® to the only comparable drug, Pulmozyme®

Methods:

In the analyses included subgroup of 46 severe pulmonary impairment patients with baseline FEV1 level 40–60% of predicted (23 patients in each treatment group) out of 100 patients registered in the study phase III open label, prospective, multi-center, randomized study (NCT04468100), and compared efficacy endpoints (FEV1, FVC, number and time of exacerbations, body weight, St.George’s Respiratory Questionnaire) as well as safety parameters (AEs, SAEs, anti-drug antibody) within 24 treatment weeks.

Results:

All outcomes were comparable among the studied groups. In the efficacy dataset, the similar mean FEV1 and mean FVC changes for 24 weeks of both treatment groups were observed. The groups were also comparable in safety, all the secondary efficacy parameters and immunogenicity.

Conclusions:

The findings from this study support the clinical Tigerase® biosimilarity to Pulmozyme® administered in CF patients with severe impairment of pulmonary function.

100 项与阿法链道酶生物类似药（Generium Pharma）相关的药物交易

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