Cynata Therapeutics Ltd. (CYP.AX) Monday announced the completion of patient enrolment in its Phase-2 clinical trial evaluating CYP-001, its Cymerus mesenchymal stem cell or MSC product candidate, in patients with Acute graft-versus-host disease.
Acute graft-versus-host disease is a serious and potentially life-threatening complication that can occur following allogenic stem cell transplantation, when donor immune cells attack the recipient's tissues. The condition often affects the skin, liver and gastrointestinal tract, with severe cases leading to high morbidity and mortality. Current treatment options, including corticosteroids, are frequently inadequate, leaving a significant unmet medical need.
CYP-001 is derived from Cynata's proprietary Cymerus platform, which enables the scalable and consistent manufacture of MSCs from induced pluripotent stem cells. MSCs are believed to exert immunomodulatory effects that can reduce inflammation and restore immune balance, making them a promising therapeutic approach for acute graft-versus-host disease and other immune-mediated disorders.
A total of 65 participants has been enrolled in the trial across numerous clinical centres in Australia, the USA, and Europe. Each participant was randomized to receive either steroids plus CYP-001, or steroids plus placebo. The trial involves a 100-day primary evaluation period, expected to conclude in March 2026 with results anticipated around June 2026.
Beyond acute graft-versus-host disease, Cynata is advancing its Cymerus MSC platform in multiple indications, including critical limb ischemia, osteoarthritis, and diabetic foot ulcers. The company is also exploring applications in respiratory diseases and broader inflammatory conditions.
CYP.AX has traded in the range of $0.27 to $ 0.28, over the past year. The stock closed Friday's trading at $0.28, up 7.54%.
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