In 2008, sitimagene ceradenovec became the first gene therapy product using an adenoviral vector that completed a Phase 3 clinical trial in Europe.5,16 However, in March 2010, Ark Therapeutics Group Ltd withdrew its application for marketing authorization following results that failed to confirm its therapeutic benefits in relation to risk.16,17

Sitimagene ceradenovec is an adenoviral vector harboring the gene for the herpes simplex virus thymidine kinase (HSV-tk), which was intended for the treatment of malignant brain tumors.5