Biotech company Cynata Therapeutics (ASX:CYP) received regulatory and ethics approval in the European Union (EU) for its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD).
CYP-001 is Cynata’s innovative Cymerus™ off-the-shelf induced pluripotent stem cell (iPSC)-derived mesenchymal stem cell (MSC) product for intravenous infusion.
The trial has been given the green light under the new EU Clinical Trials Regulation. About half of the selected clinical sites for the trial are located across the European Union including Spain, France, Italy, and Lithuania.
This approval marks the final step in the process, following clearance to proceed in the USA, Australia, and Turkey. Many clinical sites are already open for recruitment in these areas, with the first patient enrolled earlier this month.
“The successful outcome of this application further underlines the strength of the Company’s regulatory dossier, and the global applicability of our technology,” Cynata’s Chief Executive Officer Dr Kilian Kelly said.
The trial aims to enroll approximately 60 patients with high-risk aGvHD, who will be randomly assigned to receive either steroids plus CYP-001 or steroids plus a placebo.
With approvals secured across multiple jurisdictions, the company is moving forward with its mission to bring effective treatments to patients in need.
CYP has been trading at 17 cents.