Neovasculgen (PI-VEGF165) / Artgen Biotech - LARVOL DELTA

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions. (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: JSC NextGen

New P2/3 trial • Interstitial Cystitis • Musculoskeletal Pain • Pain

The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: JSC NextGen

New P3 trial • Diabetes • Hematological Disorders • Metabolic Disorders

Gene Therapeutic Drug pCMV-VEGF165 Plasmid ('Neovasculgen') Promotes Gingiva Soft Tissue Augmentation in Rabbits. (PubMed, Int J Mol Sci) - "Thus, the use of the pCMV-VEGF165 plasmid ('Neovasculgen') in combination with the xenogeneic collagen matrix Mucoderm potentiated the pro-proliferative effect of the membrane and the pro-vascularization effect of the plasmid. These results indicate the promising potential of this innovative approach for clinical applications in regenerative medicine and dentistry."

Gene therapy • Journal • Preclinical • Gene Therapies

The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial (clinicaltrials.gov) - P4 | N=386 | Recruiting | Sponsor: Amur State Medical Academy

Combination therapy • Gene therapy • New P4 trial • Cardiovascular • Gene Therapies

Emergence of Small Interfering RNA-Based Gene Drugs for Various Diseases. (PubMed, ACS Omega) - "The importance of gene therapy as an alternative to traditional drugs has increased after the discovery of gene-based drugs such as Gendicine for cancer and Neovasculgen for peripheral artery disease...siRNA-based treatment for hereditary transthyretin-mediated amyloidosis (hATTR) using Onpattro and acute hepatic porphyria (AHP) by Givlaari and three more FDA-approved siRNA drugs has set up a milestone and further improved the confidence for the development of gene therapeutics for a spectrum of diseases...They include chemical instability, nontargeted biodistribution, undesirable innate immune responses, and off-target effects. This review provides a comprehensive view of siRNA-based gene drugs: challenges associated with siRNA delivery, their potential, and future prospects."

Journal • Review • Amyloidosis • Cardiovascular • Gene Therapies • Genetic Disorders • Hematological Disorders • Hepatology • Infectious Disease • Metabolic Disorders • Oncology • Peripheral Arterial Disease

Angiogenic Modification of Microfibrous Polycaprolactone by pCMV-VEGF165 Plasmid Promotes Local Vascular Growth after Implantation in Rats. (PubMed, Int J Mol Sci) - "We did not find a statistically significant correlation between scaffold degradation rate and vessel growth (the Pearson correlation coefficient was ρ = 0.20, p-value = 0.6134). Functionalization of polycaprolactone by incorporation of the pCMV-VEGF165 plasmid provided improved vascularization within 33 days after implantation, however, vessel growth did not seem to correlate with scaffold degradation rate."

Journal • Preclinical • Cardiovascular • Fibrosis • Immunology • Infectious Disease • VEGFA

Ways of limbs salvage in postoperative period of treatment of complications of diabetic foot syndrome (PubMed, Angiol Sosud Khir) - "Group Two patients, besides basic therapy, additionally received combined treatment which was carried out in two stages and included urokinase, sulodexide, and a venotonic agent...Both groups were further subdivided into subgroups A and B. The patients in subgroups B of both groups in order to prevent progression of limb ischaemia were additionally given Neovasculgen, a genetically engineered drug for stimulation of angiogenesis...The immediate results were assessed on the 1st, 7th and 14th days of treatment by the dynamics of changes in subjective symptoms, cytograms of the wound surface, level of partial pressure of oxygen in capillary blood of foot tissues, and the necessity to perform repeated necrectomy. The remote results were evaluated by the dynamics of changes in the pain-free walking distance, maximum distance walked, ankle-brachial index, linear velocity of blood flow through tibial arteries and partial pressure of oxygen in capillary blood of the affected..."

Journal • Gene Therapies • Pain

Comprehensive treatment of a patient with Buerger's disease using genetically engineered complexes VEGF-165 (PubMed, Angiol Sosud Khir) - "Injection of this drug to the ischaemised tissues of lower extremities ensures long-term synthesis of vascular endothelial growth factor 165 leading to the development of an additional collateral vascular network and consequently to increased perfusion of tissues with oxygen and decreased degree of ischaemia. Presented herein is a clinical case report of a successful therapeutic outcome achieved in a patient suffering for a long time from thromboangiitis obliterans (Buerger's disease) and treated with genetically engineered complexes based on vascular endothelial growth factor ('Neovasculgen') used as a component of comprehensive conservative therapy."

Clinical • Journal

Conservative treatment of chronic lower limb ischemia in ambulatory practice (in Russian only) (PubMed, Khirurgiia (Mosk)) - "Current methods for risk factors adjustment, exercise therapy and the most common drugs for intermittent claudication management are reviewed in the article. The effect of these medicines on subjective (pain-free walking distance, maximal walking distance, etc.) and objective (ankle-brachial index) parameters and the incidence of complications are analyzed."

Journal • Review

The Effectiveness of Treatment for Patients With Chronic Lower Limb Ischemia Using a Plasmid Vegf65-gene Therapy Drug in the Long-term Period (ATVB-PVD-GPM 2019) - "...In 2011, the drug Neovasculgen® created on the basis of a plasmid with the VEGF-165 gene (« NextGen» LLC) was registered in the Russian Federation... In patients with stage II and III CLLI according to Rutherford classification, using a plasmid VEGF65-gene therapy in the combination treatment significantly affects the increase in the mean PFWD in a five-year follow-up study."

Clinical