Clinical-stage cell therapy company Cynata Therapeutics (ASX:CYP) has received regulatory and ethics approval to commence its Phase 2 clinical trial of CYP-001 in patients with High-Risk acute Graft versus Host Disease (HR-aGvHD) at clinical centres in Turkey.
The company said this global trial aims to enrol approximately 60 patients with HR-aGvHD, who will be randomised to receive either steroids plus CYP-001 or steroids plus placebo.
CYP-001 is Cynata’s Cymerus off-the-shelf iPSC1-derived MSC2 product candidate for intravenous infusion, which previously generated very encouraging safety and efficacy results in a Phase 1 clinical trial.
Cynata said it intends to open multiple clinical centres in Turkey, with the first site initiation visits anticipated within the next 1-2 months. The trial has already opened for recruitment in Australia and the US.
Dr Jolanta Airey, Cynata’s chief medical officer, said, “We are delighted to receive approval to commence this trial in Turkey, which is a country that we expect will make a substantial contribution to this trial. Start-up activities for this trial continue to progress well, and we remain focussed on our goals of completing patient recruitment by the end of 2024, with primary results expected in the second half of 2025.”