Hamlet BioPharma AB, an innovative Swedish pharmaceutical company, has announced the signing of a clinical trial agreement with the University of Iowa. One of the leading U.S. centers for bladder cancer research and therapy. The new study advances the clinical development of Alpha1H. A human breast milk derived treatment for bladder cancer. To include Carcinoma In Situ (CIS); a severe surface-spreading. And therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease.

Professor O’Donnell, a key opinion leader. And driver of the international bladder cancer therapy field identified. A significant unmet medical need among patients with CIS and initiated discussions. With Hamlet BioPharma and scientists at Lund University in Sweden, regarding this clinical expansion of the Alpha1H drug development program. This collaboration follows an extensive scientific and clinical evaluation of Alpha1H. By the University of Iowa, including review of published clinical data and the mechanism of action described in peer-reviewed publications.

Bladder cancer is one of the most common urological malignancies worldwide. A substantial proportion of patients experience recurrence following treatment. Creating a significant need for new therapies that can reduce recurrence rates and preserve bladder function. The clinical study is planned to be conducted under Hamlet BioPharma’s existing. Investigational New Drug (IND) application for Alpha1H in the United States through submission of. A new clinical protocol amendment to the U.S. Food and Drug Administration (FDA).

“The signing of this agreement establishes a collaboration with the University of Iowa group. Led by Professor O’Donnell, who are pioneers in the field and have defined multiple novel therapies in bladder cancer. Expanding the clinical indications to include CIS allows us to evaluate. Alpha1H in a patient population with severe and resistant disease. And a substantial unmet medical need,” says Catharina Svanborg. Professor at Lund University and Chairman of the Board of Hamlet BioPharma.

“Despite advances in bladder cancer treatment, high recurrence rates remain a major challenge. Many patients with CIS have exhausted all available treatments. Without a cure, and are faced with the prospect of bladder removal. Based on our evaluation of Alpha1H and the clinical results generated to date. We believe the Alpha1H treatment warrants further investigation in this patient group. We look forward to working with Hamlet BioPharma and the scientists. At Lund University to explore the potential of Alpha1H in patients. With treatment resistant CIS,” says Michael O’Donnell, Professor and Director of Urologic Oncology at the University of Iowa.

Hamlet BioPharma has a broad and strong portfolio of projects for the treatment of cancer and infections. A synthetic component of a natural complex first discovered in human breast milk. HAMLET means Human Alpha-lactalbumin Made LEthal to Tumor cells. Unlike conventional chemotherapies that cause widespread collateral damage, Alpha1H is engineered for precision. Administered directly into the bladder. The drug selectively enters tumor cells and triggers apoptosis. A form of programmed cell death, effectively compelling the cancer to self-destruct.

The Journal of Infectious Diseases recently published Hamlet BioPharma’s paper “Targeting the disease response with NlpD and LytM for effective non-antibiotic treatment of urinary tract infections.” This study demonstrates that inhibiting the disease response of the host offers an efficient alternative to antibiotics for the treatment of bacterial infections. By inhibiting the disease response to infection and accelerating bacterial clearance, the drug candidates protect infected tissues from disease, with similar efficacy as antibiotics. 

Other recent announcements for Hamlet BioPharma, include: European regulatory approval to begin the Phase III study of Alpha1H, providing a clear regulatory pathway toward potential marketing authorisation. Successful release of Phase III-quality drug product, enabling distribution to clinical sites across Europe and the U.S and launch preparations for the international Phase III trial, including a pre-initiation visit at Charles University in Prague. Preparations will be with internationally recognised bladder cancer expert, Marek Babjuk, whose team led the successful Phase II study.