On August 30, 2025, the world's first gene therapy drug for ischemia developed in Russia was presented at the Asian Society of Vascular Surgery (ASVS) conference in Singapore.
Professor Igor Aleksandrovich Suchkov, President of the Russian Phlebologists Association and Vice President of the Russian Society of Angiologists and Vascular Surgeons, presented the report: The Impact of Lower Limb Revascularization (Bypass Grafting) and Intramuscular VEGF 165 Gene Transfer on Blood Levels of the Angiogenic Factor VEGF in Patients with Atherosclerotic Critical Lower Limb Ischemia.
Peripheral arterial disease caused by atherosclerosis is a condition in which arterial plaques in leg arteries disrupt blood flow to the legs, leading to tissue hypoxia (ischemia). Critical ischemia is the final stage, where impaired blood supply threatens tissue viability and may require amputation.
Igor Suchkov's report is highly relevant, as the incidence of lower limb amputation in patients with critical ischemia can range from 12.1 % to 67.3 % within four years.
Neovasculgen is the first registered gene therapy drug worldwide for lower limb ischemia. It is a plasmid DNA containing the human VEGF 165 gene, which encodes the synthesis of VEGF, a key regulator of blood vessel growth and development. The drug stimulates microvascular network growth, opening a new medical area, the therapeutic angiogenesis (therapeutic vascular growth).
Igor Suchkov presented the design and materials of a study involving 60 patients to Asian vascular surgeons. The patients underwent combination therapy, which included surgical restoration of blood flow (revascularization) and therapeutic angiogenesis using Neovasculgen.
A key finding of the study was that lower extremity revascularization followed by Neovasculgen administration in the early postoperative period for patients with critical limb ischemia resulted in a 50 % increase in serum VEGF levels one month after revascularization. While Neovasculgen has previously been successfully used to treat patients with critical lower extremity ischemia, statistically significant data on the magnitude of VEGF 165 level increases in these patients were lacking. The results presented to Asian specialists provide increasing evidence supporting the use of therapeutic angiogenesis in critical lower extremity ischemia.
In Russia, Neovasculgen is used in practical healthcare for treating lower extremity ischemia. It is included in the EML, national guidelines, federal clinical statistical groups, and the Moscow Compulsory Medical Insurance Program.
Nextgen, the developer of Neovasculgen, is currently expanding its indications. The drug shows potential for treating diabetic foot syndrome, interstitial cystitis, and androgenetic alopecia.
NextGen, JSC, is a Medtech resident and a resident of the Lomonosov cluster at the Vorobyovy Gory Innovative Scientific and Technological Center of Moscow State University. The company focuses on the development and implementation of gene therapy drugs.