Cynata CYP-001 Stem Cell Therapy Meets All Safety and Efficacy Endpoints in Phase 1 Trial in GvHD

Australian stem cell and regenerative medicine company Cynata Therapeutics (ASX: CYP) is pleased to announce that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).

As quoted in the press release:

In a Day 100 analysis of patients in the high-dose Cohort B, CYP-001 demonstrated positive safety and efficacy data that is consistent with Day 100 data from the lower-dose Cohort A and a Day 28 evaluation of Cohort B. This data analysis marks the completion of the Primary Evaluation Period for all patients enrolled in the Phase 1 trial.

Dr Kilian Kelly, Cynata’s Vice President, Product Development, said, “We are pleased to announce that CYP‑001 has met all clinical endpoints in the first trial of a product based on our Cymerus stem cell technology platform, which validates its potential to generate safe and effective iPSC-derived MSC therapies. Steroid-resistant GvHD is a devastating disease with a high rate of mortality. The clinical results from patients in Cohorts A and B are highly encouraging, as all of the patients had failed to respond to corticosteroid therapy, the only approved treatment for GvHD. We look forward to advancing our Cymerus MSCs into Phase 2 trials for GvHD and other indications.”

Click here to read the full press release.