UK group Silence Therapeutics will have been celebrating this week after German regulators gave the firm permission to begin testing its lead internal candidate in a Phase I clinical trial.

The company, which is based in London and Berlin, said yesterday that the German regulator Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) has given the all clear for a Phase I study of its RNA interference drug Atu027 in patients with advanced solid tumours.

The prospective, open-label, dose-finding study, which is to take place at the clinical study centre of the Cancer Hospital SanaFontis in Freiburg, Germany, aims to test the safety, tolerability and pharmacokinetics of single and repeated intravenous doses of Atu027, and is expected to take around 18 months to complete.

Atu027 systemically delivers short interfering RNA (siRNA) - which ‘silences’ the genes involved in cancer growth and metastases - using the firm’s proprietary AtuPLEX delivery technology. According to Silence, this technology enables siRNA molecules to be delivered straight to areas of disease, while also boosting their bioavailability and intracellular uptake.

The company is certainly hopeful that, if clinical development is successful, Atu027 could become a new therapeutic option for patients with advanced solid tumours who have failed to respond to standard therapy.