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Enrolment Completed in Cynata's Phase 1 Clinical Trial of CYP-001 in GvHDMELBOURNE, Australia, May 24, 2018 (GLOBE NEWSWIRE) -- Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the final patient has been treated in Cohort B of its Phase 1 clinical trial of CYP-001, its Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD). Key highlights:
Dr Kilian Kelly, Cynata’s Vice President of Product Development, said, “Treating the final patient in the Phase 1 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 cell-derived mesenchymal stem cell therapy to patients in need.” Eight patients with steroid-resistant acute GvHD disease were enrolled in Cohort B, as originally planned. Seven out of eight patients were dosed with two infusions of CYP-001 administered one week apart. Each dose was two million cells per kilogram of body weight (cells/kg), up to a maximum dose of 200 million cells, which was twice (2x) the dose level received by patients in Cohort A. The clinical investigator determined that one patient in Cohort B was no longer a suitable candidate for treatment, due to a medical complication that occurred shortly after enrolment but prior to treatment with CYP-001. This decision was consistent with pre-specified criteria outlined in the trial protocol. The patient will be excluded from safety and efficacy analyses, as they did not receive CYP-001 treatment.
About Graft-versus-host-disease About the Phase 1 Clinical Trial (Protocol Number: CYP-GvHD-P1-01) The first eight participants were enrolled in Cohort A and received two infusions of CYP-001 at a dose of one million cells per kilogram of body weight (cells/kg), up to a maximum dose of 100 million cells. There was one week between the two CYP-001 infusions in each participant. The next eight participants were enrolled into Cohort B and received two infusions of CYP-001 at a dose of two million cells/kg, up to a maximum dose of 200 million cells. The trial’s primary objective is to assess the safety and tolerability of CYP-001, while the secondary objective is to evaluate the efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD. The primary evaluation period concludes 100 days after the first dose in each participant. Efficacy is assessed on the basis of response to treatment (as determined by change in GvHD grade) and overall survival at 28 and 100 days after the administration of the first dose. After the completion of the primary evaluation period, participants enter a longer-term, non-interventional follow-up period, which will continue for up to two years after the initial dose. About Cynata Therapeutics (ASX:CYP) 1 Westin JR, Saliba RM, De Lima M, et al. Steroid-Refractory Acute GVHD: Predictors and Outcomes. Adv Hematol. 2011; 2011:601953. |