PR Hamlet Biopharma Phase III 260917.pdf
HAMLET BioPharma is proud to announce that the clinical phase of the Phase III trial has started. Patients with non-muscle invasive bladder cancer are being enrolled and treated according to the study protocol, which is approved by the European and US authorities, EMA and FDA.
This remarkable milestone is reached shortly after the company communicated the successful approval process with the EMA at the end of June, the successful production of Alpha1H drug at Phase III quality and transport to the trial site and the trial site initiation with the clinical team at Motol hospital in Prague, led by Professor Babjuk and his team.
In parallel, the company is moving to start a separate clinical study in patients with severe, therapy resistant cancer in situ, at the Department of Urology, University of Iowa.
”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” says Professor Catharina Svanborg, Chairman of the Board.
For further information, please contact
Jakob Testad, CEO, Hamlet BioPharma AB, +46 708 48 42 10
jakob.testad@hamletbiopharma.com
Catharina Svanborg, Chairman of the Board, Hamlet BioPharma AB, +46 709 42 65 49
catharina.svanborg@hamletpharma.com
This disclosure contains information that Hamlet BioPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-09-2026 08:59 CET.