Cynata Therapeutics obtained regulatory and ethics approval to initiate Phase 2 clinical trials for CYP-001 in Turkey's high-risk acute graft versus host disease.
The study, which has already started recruiting in Australia and the U.S., aims to enrol roughly 60 patients and will evaluate the efficacy of a combination treatment involving steroids and CYP-001, an intravenous infusion product based on a proprietary therapeutic stem cell platform technology.
The company plans to establish multiple clinical centres in Turkey, with the first site initiation visits expected in the next one to two months.
The company plans to complete recruitment by the end of 2024 and expects the trial's primary results in the second half of 2025.