Patients in Cohort A Respond Well, 1st Patient in Cohort B Dosed in Cynata’s CYP-001 Trial
Australian stem cell company, Cynata Therapeutics has released exciting early results from its ongoing clinical trial in the UK utilizing an iPS cell-derived mesenchymal stem cell (MSC) therapeutic product.
The completion of the Day 28 visit of its last patient (8th overall) in Cohort A of the clinical trial triggered the planned independent Data Safety Monitoring Board (DSMB) review of data from this cohort. As reported January 21st, 2018, the DSMB has completed its review and recommended that the trial should proceed to the next stage, i.e. to Cohort B. Participants in Cohort B will receive twice (2x) the dose of patients in Cohort A.
Cynata Therapeutics also reported that the patients in Cohort A responded very well to CYP-001, with no treatment-related serious adverse events or safety concerns. It is notable that 100% of participants showed a measurable and meaningful improvement in GvHD grade (severity).
While it is premature to draw robust conclusions about efficacy until the full results of the trial are analysed upon trial completion, these initial signs, especially at the lower of the two doses, are encouraging. Recruitment of participants in Cohort B has now opened at 7 centres in the U.K. and Australia with our goal to complete the trial later this year.
On January 24th, 2018, the company subsequently dosed the first patient in Cohort B of its ongoing Phase 1 clinical trial in acute steroid-resistant graft-versus-host disease.
To learn more, click here to read the full announcement from Cynata Therapeutics.