Clinical-stage cell therapy company Cynata Therapeutics (ASX:CYP) has received approval from the Australian Human Research Ethics Committee to commence the proposed Phase 2 clinical trial in acute graft-versus-host disease (aGvHD).
Cynata said it is finalising contractual and logistic arrangements with individual sites to prepare for patient recruitment.
The approval follows the clearance by the US FDA of Cynata’s Investigational New Drug (IND) application in 2022, the grant of Orphan Drug Status for CYP-001 and Institutional Review Board approval in the US.
The proposed clinical trial titled 'A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease' is expected to be conducted in approximately 60 patients at sites across the US, Europe and Australia.
Dr Jolanta Airey, Cynata’s chief medical officer, said, “We continue to make good progress towards commencing a Phase 2 clinical trial in aGvHD, with our expectations being to commence patient recruitment this quarter and to complete our primary evaluation of the trial data in 2024. The proposed clinical trial has a strong foundation given the very promising results achieved in our phase 1 clinical trial of CYP-001 in steroid resistant aGvHD.”