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Patient Enrolment Completed in Phase 2 aGvHD Clinical Trial
The trial enrolled 65 high-risk acute graft versus host disease patients to evaluate CYP-001’s immune-modulating effects versus placebo with steroids, addressing steroid resistance.
- On Dec. 14, 2025, Cynata Therapeutics Limited said it completed patient enrolment in its Phase 2 trial of CYP-001 for adults with high‑risk aGvHD, enrolling 26 participants across multiple regions.
- Because steroids fail in roughly half of cases, acute graft versus host disease remains life-threatening, with steroid‑resistant aGvHD showing under 20% two‑year survival.
- The trial uses a 100‑day primary evaluation period expected to conclude in March 2026, with topline results anticipated around June 2026.
- The primary endpoint is Overall Response Rate at Day 28, CYP-001 holds US FDA Orphan Drug Designation, and Dr Kilian Kelly said Cynata is optimistic about Phase 2 results.
- Cymerus technology uses induced pluripotent stem cells to overcome mesenchymal stem cells manufacturing limits, enabling scalable production without ongoing donor tissue sourcing amid aGvHD impact .
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Patient Enrolment Completed in Phase 2 aGvHD Clinical Trial
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Total News Sources57
Leaning Left4Leaning Right7Center19Last UpdatedBias Distribution63% Center
Bias Distribution
- 63% of the sources are Center
63% Center
14%
C 63%
R 23%
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