The international clinical trials registry of the US National Institutes of Health has published data on the initiation of clinical trials of combination gene therapy using a gene therapy drug developed by Russian biotech company NextGen.
The purpose of the study is to evaluate the safety of Neovasculgen in combination with gene therapy using the Follistatin gene to prevent age-related muscle loss in healthy individuals aged 45-75 years. The study will be conducted on 12 volunteers and will continue until 2028.
The study on the territory of the Prospera ZEDE zone in the Republic of Honduras is being conducted by Unlimited Bio. All activities will be carried out in strict accordance with the regulatory requirements of Prospera, including obtaining necessary approvals from ethics committees and an insurance company, and in compliance with ICH GCP principles. The study results will be published on clinicaltrials.gov.
As part of the independent research project CALM-AF-AI (Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy), the Unlimited Bio team has voluntarily undertaken to provide NextGen with anonymized summary information on the progress and results of the study in accordance with applicable regulatory and data protection requirements.
Neovasculgen is actively used in practical healthcare for the treatment of lower limb ischemia. It is the world's first officially registered drug with a gene therapy mechanism of action. The drug stimulates the formation and growth of new blood vessels — "therapeutic angiogenesis". Neovasculgen is included in the List of Vital and Essential Drugs, incorporated into national guidelines, federal clinical and statistical groups, and the Moscow Compulsory Health Insurance program.
Given that Neovasculgen stimulates therapeutic angiogenesis and is aimed at treating tissue ischemia, the drug has potential for treating other diseases where increased vascular network density is required — in particular, diabetic foot syndrome, interstitial cystitis, and alopecia. NextGen is currently working to expand the indications for the drug.
NextGen is a resident of MedTech and a resident of the "Lomonosov" cluster of the Innovative Scientific and Technological Center of Moscow State University "Vorobyovy Gory". The company is part of the Artgen Biotech Group (MOEX: ABIO) and specializes in the development and implementation of gene therapy drugs and the expansion of indications for Neovasculgen.
Unlimited Bio is a biotech startup based in the Prospera ZEDE zone in the Republic of Honduras. The company's work is built around seeking therapies capable of slowing down the processes associated with aging before they develop into diseases.