Cynata Therapeutics Limited has announced that it has received approval to commence the proposed phase 2 clinical trial in acute graft-
versus-host disease (aGvHD) from Advarra Inc., a central Institutional Research Board (IRB) service provider in the USA. IRB approval is an essential step in the process of opening clinical study sites and to commencing a clinical trial in humans in the United States. Cynata is now finalising contractual and logistic arrangements with individual sites (hospitals) to prepare for patient recruitment. This follows the landmark clearance of Cynata's Investigational New Drug (IND) application in 2022 and grant of Orphan Drug Status for CYP-001. The proposed clinical trial is 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" and is expected to be conducted in around 60 patients at sites in the United States, Europe and Australia.