Silence Therapeutics receives approval to initiate Phase I clinical trials on Atu027 for treatment of patients with advanced solid tumours
London - June 3, 2009 - Silence Therapeutics plc (AIM: SLN) ("Silence" or "the Company"), the leading European biopharmaceutical company focused on RNA interference (RNAi), announces that its Clinical Trial Application (CTA) for Atu027, its lead drug candidate, has been cleared by the German regulator Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
The planned trial will be a prospective, open-label, single-centre, dose-finding Phase I study with Atu027 in patients with advanced solid (malignant) tumours involving single as well as repeated intravenous administration.
The trial will be conducted at the clinical study centre of the Cancer Hospital SanaFontis in Freiburg, Germany and will address safety, tolerability and pharmacokinetics. Silence has already received approval from the Ethics Committee and the trial, which is expected to take approximately 18 months to complete, will commence immediately following successful patient enrolment.
Atu027 specifically targets PKN3, a molecule involved in cancer growth and metastasis formation. Atu027 is Silence's most advanced clinical candidate for a systemically delivered short interfering RNA (siRNA) using the Company's proprietary AtuPLEX delivery technology. The compound is a potential new therapeutic option for patients with advanced solid tumours that do not adequately respond to standard therapy.
Iain Ross, chairman and chief executive of Silence Therapeutics, said:
"We welcome the decision by the German regulator to allow Silence to take Atu027 forward into Phase I clinical testing. This marks a further step in the development of Silence's science towards commercialisation and underscores the company's strength in the field of RNAi."
Klaus Giese, Chief Scientific Officer of Silence Therapeutics, added:
"We are very excited at the prospect of commencing Phase I testing of Aut027 in subjects with advanced solid tumours. We believe that our AtuPLEX delivery system can be applied for the delivery of different siRNAs for several targets in indications that are connected with angiogenesis, which is key to tumour growth and metastasis."