Silence's Ph I Atu027 trial cleared in Germany
UK RNAi specialist Silence Therapeutics has been cleared by the German drug regulator to begin Phase I trials of Atu027, its lead drug candidate.
The planned study will be a prospective, open-label, single-center, dose-finding Phase I trial with Atu027 in patients with advanced solid tumors involving single, as well as repeated, intravenous administration.
The trial will be conducted at the clinical study center 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 18 months to complete, will commence immediately following successful patient enrolment.
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