Cynata Therapeutics Ltd (ASX:CYP) has treated the final patient in its phase I clinical trial of CYP-001 for adults with steroid-resistant acute graft-versus-host-disease (GvHD).
GvHD is a complication that can occur after a bone marrow transplant or similar procedure when the donor’s immune cells (from the graft) attack the recipient of the transplant (the host).
The only approved treatment for GvHD is corticosteroid therapy, which is typically only effective in about 50% of patients.
Enrolment and dosing now complete
Patient enrolment and dosing in the phase I trial has completed, with data analysis to commence at 28 and 100 days post-treatment.
This follows positive safety and efficacy data from the primary evaluation period of patients in Cohort A, in which overall survival at day 100 was 87.5%, overall response rate by day 100 was 100% and complete response rate by day 100 was 50%.
Working towards a new stem cell therapy
Cynata’s vice president of product development Dr Kilian Kelly said: “Treating the final patient in the phase I trial of our novel CYP-001 stem cell therapy in GvHD represents a significant milestone and great achievement for Cynata.
“In an analysis of patients in Cohort A, CYP-001 demonstrated strong efficacy and compelling patient response, as well as a lack of treatment-related serious adverse events, which is very encouraging in this devastating and often fatal disease.
“A positive trial outcome would bring us one step closer to providing the first-ever allogenic induced pluripotent stem cellderived mesenchymal stem cell therapy to patients in need.”