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Hamlet BioPharma Announces the Completion of the Alpha1H Phase II Study in Non-Muscle Invasive Bladder Cancer
Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, announces the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. The final clinical report
About this update from Hamlet Biopharma Ab Class B
[{"type":"text","content":"LUND, Sweden, Aug. 21, 2025 /PRNewswire/ -- Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, announces the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. The final clinical report has been completed and submitted to the FDA (Food and Drug Administration, USA).","length":629,"tagName":"p"},{"type":"text","content":""The final clinical report's consistent efficacy outcomes and favorable safety profile are highly encouraging. The strength of the data provides compelling evidence of Alpha1H's potential to become a much-needed proactive treatment option, and we look forward to advancing it in our regulatory discussions. We are committed to bringing this innovative therapy to patients as quickly and safely as possible. These results mark a major milestone for Hamlet BioPharma and for people with cancer in the urinary bladder. The study was made possible through close collaboration with leading universities and medical centers, including Lund University, Sweden, Motol University Hospital, Czechia and Linnane Pharma AB, whose combined expertise ensured robust design, execution, and analysis," said Catharina Svanborg, MD, PhD and CEO Hamlet BioPharma. ","length":862,"tagName":"p"},{"type":"text","content":"Summary from the Clinical Study Report","length":38,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Efficacy was formally confirmed – 80% of tumors responded to Alpha1H, with 59% average tumor size reduction in the high-dose group","length":130,"tagName":"p"}]},{"val":[{"type":"text","content":"Molecular and cellular secondary endpointsAlpha1H reaches tumor tissue, triggers tumor cell apoptosis, and causes rapid shedding of tumor cells into the urine.","length":160,"tagName":"p"}]},{"val":[{"type":"text","content":"Durable effect shown across repeated treatment cyclesPatients who received a second round of instillations maintained clinical benefit, showing continued tumor cell death and reduction — demonstrating the treatment&...