Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical
application was already proven in preclinical and in clinical trial in treatment of melanoma
skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid
coding for IL-12 has proven safe end effective, having good local tumour control and some
evidence indicates on abscopal effect. The EU directives recommend the use of plasmids
without the gene for antibiotic resistance. For this purpose we constructed plasmid coding
for IL-12 in accordance with the EU regulatory requirements.
In the proposed study we intend to study the safety and tolerability of the constructed
plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in
head and neck region. The study is designed as exploratory, dose escalating with the aim to
determine the dose of plasmid that produces IL-12 expression in the tumours with best
biological activity, infiltration of the immune cells and no toxicity.