Nextgen of the Artgen Biotech Group (ex. Human Stem Cell Institute, MOEX: ABIO) has completed enrollment of patients to participate in the clinical trial of a gene therapy drug for the treatment of diabetic foot syndrome (DFS).
A phase 2 registration clinical trial with 99 patients is being conducted according to the protocol: “Prospective, Blind, Multicenter, Placebo-Controlled, Randomized, Two-Arm Clinical Study of the Safety and Effectiveness of Neovasculgen in Patients with Diabetic Foot Syndrome” (permit of the Ministry of Health of the Russian Federation No. 737 dated 10/17/2016).
The study began in June 2019. Follow up will continue until March 2024, after which Nextgen will prepare a final report for submission to the Ministry of Health to obtain a permit to conduct the final, third phase of the diabetic foot syndrome treatment clinical trial.
The previous preclinical and pilot trials showed that the introduction of the gene therapy drug into the affected tissue shortens the healing time of ulcerative defects and improves the quality of tissue regeneration in diabetic patients.
“The enrollment of patients in the ongoing trial was difficult and took several years for a number of reasons,” comments Sergey Radayev, Nextgen’s Medical Director. “The trial protocol was changed twice to expand the inclusion criteria. Strict criteria for selecting patients combined with the change in the country’s medical care structure, especially the virtual dissolution of the staged care structure for DFS patients in most regions of the country, greatly complicated the search for patients who meet the selection criteria. The Covid-19 pandemic led to stricter restrictions, access to clinical centers for patients with diabetic foot syndrome as one of the most vulnerable groups of the population was terminated, completely paralyzing the enrollment into the trial for 2.5 years.”
According to official statistics, the number of people with diabetes in Russia reached 5.2 million people in 2021, while experts estimate that the real number may be about 10.5 million people, including those who do not yet know about their disease. Among people with diabetes mellitus, 40% to 60% have late complications in the form of diabetic foot syndrome. This is one of the disease complications characterized by damage to the blood vessels, nerves, bone and muscle tissue in the lower leg. In 2021, the incidence of DFS in Russia was 44 thousand people.
Foot ulcers lead to a severe outcome, amputation. Despite the developed protocols and standards, high efficiency in the treatment of DFS still cannot be achieved. Therefore, there is a need to create new medical technologies that will complement the existing basic approaches to the treatment of DFS, shorten the healing time of ulcers and reduce the risk and frequency of amputations.
Neovasculgen is the first Russian gene therapy drug for the treatment of lower limb ischemia of atherosclerotic origin. The drug is included in the essential drug list, national guidelines, federal diagnosis-related groups, Moscow’s compulsory medical insurance program and is actively used in medical practice. With an innovative mechanism of action, the drug has opened a whole new area: “therapeutic angiogenesis” (therapeutic generation of blood vessels). The use of the drug in patients with chronic ischemia stimulates the growth of the vascular network and reduces ischemia symptoms. The drug has the potential to treat other diseases that require a vascular density increase. In September 2016, Nextgen received a patent for a gene therapy method for treating diabetic foot syndrome (No. 2599507). Nextgen is also registering a clinical trial to explore the use of therapeutic angiogenesis for the treatment of interstitial cystitis.
Nextgen is a resident of Medtech, the Lomonosov Cluster of the Vorobyovy Gory MSU Innovative Technology Research Center. The company develops and implements gene therapy drugs, expands the indications for use of Neovasculgen.