Delving into the Latest Updates on Neovasculgen with Synapse

Overview

Basic Info

Drug Type

Gene therapy

Synonyms

cambiogenplasmid, Vascular endothelial growth factor gene therapy, VEGF gene therapy

+ [1]

Target

VEGF-A

Action

stimulants, inducers

Mechanism

VEGF-A stimulants(Vascular endothelial growth factor A stimulants), Angiogenesis inducers

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Peripheral Arterial Disease

Inactive Indication

Diabetic foot ulcer

Originator Organization

Artgen Biotech PJSC

Active Organization

Artgen Biotech PJSC

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Russia (07 Dec 2011),

Peripheral Arterial Disease

Regulation-

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"Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Study of the Efficacy and Safety of the Drug Neovasculgen® Lyophilisate for the Preparation of a Solution for Intramuscular Administration 1.2 mg", Manufacturer Federal State Budgetary Institution "NMITs of Hematology" of the Ministry of Health of the Russian Federation, Russia in Patients With Diabetic Foot Syndrome"

The main objective of the study is to evaluate the efficacy and safety of Neovasculgen® in a course dose of 2.4 mg in combination with standard drug therapy in patients with unilateral neuroischemic form of diabetic foot syndrome.

Start Date11 Feb 2025

Sponsor / Collaborator-

NCT06473740

/ RecruitingPhase 4IIT

Multicenter Randomized Prospective Controlled Trial of the Clinical Effectiveness of a Best Endovascular Treatment Versus a Best Endovascular Treatment in Combination With Gene Therapy for Severe Limb Ischemia

GENEVA is the world's first multicenter, randomized, prospective, controlled trial of the clinical effectiveness of best endovascular treatment versus best endovascular treatment combined with gene therapy for severe lower limb ischemia (Rutherford categories 4 and 5). The researchers hypothesized that the combination treatment would significantly reduce the number of re-interventions on the operated segment and high amputations, and also significantly increase the time interval between re-interventions.

Start Date20 Jun 2024

Sponsor / Collaborator-

NCT07391306

/ RecruitingPhase 2/3

Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC)

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.

Start Date16 Feb 2024

Sponsor / Collaborator-

100 Clinical Results associated with Neovasculgen

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100 Translational Medicine associated with Neovasculgen

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100 Patents (Medical) associated with Neovasculgen

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8

Literatures (Medical) associated with Neovasculgen

01 Jan 2020·Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery

Ways of limbs salvage in postoperative period of treatment of complications of diabetic foot syndrome

Article

Author: Krivoshchekov, E P ; Rodnianskiĭ, D V ; Aliapyshev, G S ; Romanov, V E ; El'shin, E B

The article deals with the use of a genetically engineered drug for stimulation of angiogenesis as a component of combined treatment of complications of ischaemic form of diabetic foot syndrome, showing comparative results of using therapeutic angiogenesis in patients in whom it was impossible to perform operative revascularization of the affected extremity, also providing a detailed description of the methodology of combined treatment of pyonecrotic complications of diabetic foot syndrome. The study included a total of 62 patients with pyonecrotic complications of Wagner grade III-IV diabetic foot syndrome. The patients were divided into two groups. Group One patients after minor amputation on the foot were assigned to receive conventional basic therapy and topical treatment of the foot wound with antiseptics and modern dressings. 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. Local treatment of the foot wound was performed with the help of two-stage vacuum therapy. 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 patients of subgroups A of both groups did not receive this drug. 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 limb at the 6th, 12th and 36th months after the performed treatment, as well as by the limb salvage and patients' survival during 3 years.

01 Sep 2018·Therapeutic advances in cardiovascular disease

Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication

Article

Author: Bozo, Ilia ; Mzhavanadze, Nina ; Suchkov, Igor ; Staroverov, Ilia ; Kalinin, Roman ; Plaksa, Igor ; Deev, Roman ; Isaev, Artur ; Chervyakov, Yuriy

Background::

The effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression, and new treatment methods are needed. In 2011, a plasmid VEGF65-gene therapy drug was approved in Russia for the treatment of chronic lower limb ischemia ( ClinicalTrials.gov identifier: NCT03068585). The objective of this follow-up study was to evaluate the long-term safety and efficacy of gene therapy in patients with limb ischemia of atherosclerotic genesis.

Aims::

To evaluate the long-term safety and efficacy of the therapeutic angiogenesis, 36 patients in the treatment group (pl- VEGF165) and 12 patients in the control group participated in a 5-year follow-up study. Planned examinations were carried out annually for 5 years after pl- VEGF165 administration.

Results::

Differences in the frequency of major cardiovascular events (pl- VEGF165 5/36 versus control 2/12; p = 0.85), malignancies (pl- VEGF165 1/36 versus control 0/12; p = 0.38) and impaired vision (there was none in either group) over the 5-year follow-up period did not achieve statistical significance. The target limb salvage was 95% ( n = 36) and 67% ( n = 12) in the pl- VEGF165 and control groups, respectively. The pain-free walking distance value increased by 288% from 105.7 ± 16.5 m to 384 ± 39 m in the treatment group by the end of the fifth year, with a peak of 410.6 ± 86.1 m achieved by the end of the third year. The ankle-brachial index (ABI) increased from 0.47 ± 0.01 to 0.56 ± 0.02 by the end of the first year, with a subsequent slight decrease to 0.51 ± 0.02 by the fifth year. The maximum increment of transcutaneous oximetry test (tcoO2) by 36%, from 66.6 ± 3.7 mm Hg to 90.7 ± 4.9 mm Hg, was observed by the end of the second year.

Conclusion::

The therapeutic effect of angiogenesis induction by gene therapy persists for 5 years.

01 Jun 2017·American journal of cardiovascular drugs : drugs, devices, and other interventions

Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease

Article

Author: Bozo, Ilia ; Isaev, Artur ; Plaksa, Igor ; Deev, Roman

INTRODUCTION:

The effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression, and new treatment methods are needed. pl-VEGF165, a gene therapy drug, was approved in Russia for the treatment of atherosclerotic peripheral arterial disease (PAD) after clinical studies in 2011. The study drug is an original gene construction in which pl-VEGF165 1.2 mg is the active substance.

OBJECTIVE:

This postmarketing surveillance study was undertaken to evaluate the safety (identification of uncommon side effects) and efficacy of gene therapy in patients in routine clinical practice.

METHODS:

In total, 210 patients with stage II-III chronic limb ischemia (according to the Fontaine classification modified by AV Pokrovsky) in 33 healthcare facilities in Russia and the Ukraine were enrolled in the study. The control group (n = 60) received conservative therapy without prostaglandins and prostacyclins, and the treatment group (n = 150) received treatment with pl-VEGF165 as two intramuscular injections for a total dose of 2.4 mg. Pain-free walking distance (PWD) (the primary efficacy criterion for Fontaine stages II-III), blood flow linear velocity (BFLV), and ankle-brachial index (ABI) were monitored for 6 months. The safety of pl-VEGF165 gene transfer in terms of the trial protocol was initially evaluated 6 months after the start of the study; adverse events (AEs) and serious adverse events (SAEs) were recorded during both routine visits and unscheduled requests for medical care.

RESULTS:

Overall, PWD increased by 177%, from 100.3 ± 6.9 to 277.1 ± 16.2 m (p = 0.0001), in the treatment group, whereas the mean value was unchanged in the control group (p = 0.218). Both BFLV and ABI values increased by 24% (p = 0.0001) in the treatment group but decreased in the control group. The greatest therapeutic effect was observed for stage III disease: PWD increased by 683% (p = 0.0001). No angiogenic therapy-related AEs or side effects were recorded, and target limb salvage was 96 and 97% in the treatment and control groups, respectively. The results obtained in this study are not significantly different from those observed in the phase IIb/III registration clinical study completed in 2011.

CONCLUSION:

pl-VEGF165 intramuscular gene transfer is an effective treatment for moderate to severe claudication due to chronic lower limb ischemia in routine clinical practice. ClinicalTrials.gov identifier: NCT02369809.

100 Deals associated with Neovasculgen

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External Link

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-	Neovasculgen	V09G	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral Arterial Disease	Russia	Artgen Biotech PJSC	07 Dec 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot ulcer	Clinical	Russia	Artgen Biotech PJSC	01 Aug 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03068585 (Pubmed \| Ther Adv Cardiovasc Dis)	Phase 2/3	Intermittent Claudication \| Peripheral Arterial Disease	100	pl-VEGF165	rdqvrrkwnd(hzfasbcysg) = jjmqmbklrh fkjskhgejd (aizovzbqzp )	Positive	01 Sep 2018
NCT02369809 (Pubmed \| Am J Cardiovasc Drugs)	Phase 4	Peripheral Arterial Disease	210	Control group	ilyvtwwoqm(yelljfbynt) = hihifnqhuy vhcgdjtvqr (yzmfxkctwr )	Positive	01 Jun 2017
NCT02369809 (Pubmed \| Am J Cardiovasc Drugs)	Phase 4	Peripheral Arterial Disease	210	Treatment group	ilyvtwwoqm(yelljfbynt) = nluprmgywi vhcgdjtvqr (yzmfxkctwr )	Positive	01 Jun 2017