Tigeraze (dornase alfa biosimilar) / Generium - LARVOL DELTA

A Study of the Comparability of the Pharmacodynamic, Toxicological, and Pharmacokinetic Properties of the Reference Drug Pulmozyme® and the Biosimilar Drug Tigerase®. (PubMed, Dokl Biochem Biophys) - "The pharmacokinetic parameters of the drugs in the blood serum, bronchi, and lungs, as well as the main physiological parameters (body weight and temperature, the state of the cardiovascular, respiratory, excretory systems, hematological and biochemical blood parameters, pathomorphological changes in internal organs (including the state of the cornea), and mortality rates) were investigated in comparative studies of subchronic toxicity in juvenile and mature rats with 28-day inhalation at doses of 0.2 mg/kg for mature animals and 0.26 mg/kg for juvenile animals (the dose was 6 times higher than the dose recommended for clinical use). The results of the studies allow us to conclude that the drugs are comparable in enzymatic, mucolytic (secretolytic) DNase activity, safety profile and main pharmacokinetic parameters."

Journal • PK/PD data • Cardiovascular • Cystic Fibrosis • Genetic Disorders • Hematological Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of PEGylation on drugs' pharmacokinetic parameters; from absorption to excretion. (PubMed, Curr Drug Deliv) - "For example, using different forms of a single drug molecule (like Citalopram and Escitalopram); a bit changes in the drug's molecule like Meperidine and α-Prodine, and using carriers (like Tigerase®). All of them, although they will not necessarily lead to an increase in the effect of the drug, 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."

Journal • PK/PD data

Possibilities of using recombinant human deoxyribonuclease I in otorhinolaryngology (PubMed, Vestn Otorinolaringol) - "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."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Tolerability of tigerase (dornase alfa) in children  (ECFS 2022) - "Dornase alfa (Tigerase, Generium, Russia) was well tolerated by children with CF under the age of 6 years - in 90% of cases and at the age of 6-18 years - in 94.5% of cases. From AEs, cough and local skin reactions were more often observed. In 29/47 patients (62% of patients with AEs), the development of AEs did not require discontinuation of dornase alfa therapy."

Clinical • Cough • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

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)). (PubMed, PLoS One) - P3 | "The findings from this study support the clinical Tigerase® biosimilarity to Pulmozyme® administered in CF patients with severe impairment of pulmonary function."

Clinical • Journal • P3 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19 (clinicaltrials.gov) - P3; N=100; Completed; Sponsor: AO GENERIUM; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • CRP

Tigerase Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19 (clinicaltrials.gov) - P3; N=100; Recruiting; Sponsor: AO GENERIUM

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis (clinicaltrials.gov) - P3; N=100; Completed; Sponsor: AO GENERIUM

Clinical • New P3 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases