A phase I study of the Dz13 drug targeting the c-Jun gene in subjects with skin cance (nodular Basal Cell Carcinoma).

The purpose of this study is to test the safety of a new treatment (Dz13 combined with DOPE and DOTAP) for nodular BCC, a form of skin cancer. Dz13 is a small piece of DNA which binds to an mRNA molecule in the cell which in turn produces a specific protein known as c-Jun. The c-Jun gene is known to be abnormally active in many types of cancer cells, including BCC, causing the abnormal production of the c-Jun protein molecule. The c-Jun protein is involved in 'switiching on' other genes involved in cell growth, resulting in growth and spread of tumour cells. Dz13 binds to the c-Jun mRNA and chops it into two pieces, which disrupts production of the c-Jun protein and limits the growth and spread of the tumour. c-Jun is present at very low levels in normal adult tissues and is mostly expressed at high levels in tumour tissue. It is hypothesised that Dz13 will be able to stop the growth and spread of BCC and other skin tumours without significant toxicity. Dz13 has been shown in animal studies to be well tolerated at doses 35-fold higher than the highest dose that will be used in this study.