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Potential breakthrough gene therapy for treatment of skin cancer

The Ljubljana-based Institute of Oncology is the first holder of a license to conduct a clinical trial of gene therapy for skin cancer of the head and neck. Unlike conventional cancer therapy which relies on drug treatment, surgery and radiotherapy, gene therapy uses genes to treat cancer cells. The first two patients are already being treated.

Successful completion of the SmartGene.Si project has put Slovenia on the global map of gene therapy bringing the country one step closer to introducing gene therapy for treating patients with skin cancer of the head and neck. The Smart.Gene.si consortium was given green light by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia to conduct a clinical trial and to explore the potential of gene therapy on volunteer patients diagnosed with skin cancer of the head and neck. As part of the project, the Institute of Oncology Ljubljana developed and produced a genetic drug for cancer therapy; a clinical trial which includes two patients is already underway to explore the potential of gene therapy in line with the clinical trial protocol. This makes Slovenia the second country in the world after the USA to conduct a clinical trial aimed at testing the potential of a gene therapy using a genetic drug with an interleukin-12 (IL-12) gene transcript.

The goal of gene therapy is to introduce to a cancer cell a gene that encodes a foreign therapeutic protein in the nucleus of cell and generates a therapeutic effect. Gene is incorporated in the cells in the form of vectors, such as viruses or plasmid DNA. Plasmid DNA is commonly delivered to the cells by electroporation. The project prides itself in the developed electroporation device for plasmid DNA delivery to cells.

The project was completed in September 2021 and brought together the Institute of Oncology Ljubljana as the applicant, COBIK, Iskra PIO, JAFRAL and the Faculty of Electrical Engineering at the University of Ljubljana. It was also implemented with the help of the Veterinary Faculty at the University of Ljubljana and the Department of Otorhinolaryngology and Cervicofacial Surgery of the University Medical Centre Ljubljana (ORL Clinic).  

For more information about the project, please visit this website.

Beneficiary: Institute of Oncology Ljubljana  

Programme: Operational Programme for the Implementation of the European Cohesion Policy

in the Period 2014-2020

Fund: European Regional Development Fund

Total project funding: EUR 2,736,285.00

EU contribution:  EUR 1,998,414.50

 Photos: Institute of Oncology Ljubljana