Posted: 12 April 2023
Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, has today announced that it has received approval from the Australian Human Research Ethics Committee (HREC) to commence the proposed Phase 2 clinical trial in acute graft-versus-host disease (aGvHD).
Ethics committee approval is an essential step in the process of opening clinical study sites and to commencing a clinical trial in humans at the proposed Australian study sites. Cynata is currently finalising contractual and logistic arrangements with individual sites (hospitals) to prepare for patient recruitment. This approval follows the landmark 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 (IRB) approval in the United States.
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 U.S., 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.”
