Highlights
- Cynata has secured Institutional Research Board (IRB) approval to start the proposed acute graft versus-host disease (aGvHD) phase 2 clinical trial in the US.
- The approval was granted by Advarra, Inc., a central IRB (i.e. ethics committee) service provider in the USA.
- IRB approval is an essential step in the process of opening clinical study sites and commencing a clinical trial in humans in the United States.
- As per the company, the new study will be based on the excellent results achieved in phase 1 clinical trial of CYP-001, in which all safety and efficacy endpoints were met.
Cynata Therapeutics (ASX:CYP) has marked a major development, securing IRB approval to start the proposed phase 2 clinical trial in aGvHD in the United States. The approval has been granted by Advarra, Inc., a central Institutional Research IRB service provider in the US.
Cynata is an ASX-listed clinical-stage stem cell and regenerative medicine company. Based on its patented therapeutic stem cell platform technology Cymerus™, the company is committed to developing therapies for unmet medical needs. CYP-001, the lead product candidate of Cynata, is undergoing clinical development for aGvHD.
IRB approval for proposed aGvHD phase 2 clinical trial
Securing IRB approval is a critical step in the process of opening clinical study sites and commencing a clinical trial in humans in the United States.
Cynata is now concluding contractual and logistic procedures with individual sites (hospitals) to arrange for patient recruitment. The development follows the milestone clearance of Cynata’s Investigational New Drug (IND) application in 2022 and grant of Orphan Drug Status for CYP-001, as well as very promising results from a Phase 1 clinical trial.
Commenting on the progress, Dr Jolanta Airey, Cynata’s Chief Medical Officer, said:
© 2023 Krish Capital Pty. Ltd., Data and image source: Company update
Meeting all clinical endpoints, CYP-001 indicated positive safety and efficacy data for the treatment of steroid-resistant aGvHD in the Phase 1 trial.
Overview of the Proposed Trial
The title of the proposed clinical trial is “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”. It is anticipated to be carried out in nearly 60 patients at sites in Australia, Europe, and the United States.
Besides this milestone achievement in the United States, Cynata is making progress in Europe and Australia, Dr Airey highlighted. The company anticipates starting patient recruitment in the coming few months and aims to complete the initial evaluation of the trial data in 2024.
CYP shares were trading at AU$0.33 midday on 1 February 2023.