TGA approval for Actinogen Medical’s XanADu trial
9 March 2017 via Biotech Dispatch: Actinogen Medical (ASX: ACW) has announced TGA approval to conduct XanADu, its phase 2 clinical trial of its drug candidate, Xanamem.
The TGA approval follows similar approvals from the US FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
It is the final regulatory approval required for the trial to begin actively recruiting patients in Australia, the US and the UK by early Q2 2017.
XanADu is a double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease.
It will enrol 174 patients at 20 research sites across Australia, the UK and the US.
Read more in Biotech Dispatch.