Hamlet BioPharma commences patient enrollment for Phase III bladder cancer trial
Hamlet BioPharma has begun patient enrollment for its Phase III clinical trial for non-muscle invasive bladder cancer. The study protocol has received approval from European and US regulatory authorities.
Lund, Sweden – Hamlet BioPharma announced on September 17, 2026, that patient enrollment and treatment have commenced for its Phase III clinical trial targeting non-muscle invasive bladder cancer. The trial protocol has been approved by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
This development follows shortly after the company secured EMA approval for the study in late June. Hamlet BioPharma also confirmed the successful production of the Alpha1H drug at Phase III quality standards and its subsequent transport to the trial site. The clinical site initiation at Motol University Hospital in Prague, led by Professor Babjuk and his team, has also been completed.
In parallel, the company is preparing to initiate a separate clinical study for patients with severe, therapy-resistant cancer in situ. This study will be conducted at the Department of Urology at the University of Iowa in the United States.
"Everyone in our extended organization is proud and excited to start the clinical part of the Phase III study. We are extremely grateful for the commitment of the Prague team of bladder cancer experts and the regulatory support by InClino," stated Professor Catharina Svanborg, Chairman of the Board at Hamlet BioPharma.