Swedish biotechnology company Hamlet BioPharma AB (Spotlight Stockmarket:HAMLET) on Thursday announced that its newly completed Phase II clinical trial evaluating Alpha1H in patients with non-muscle invasive bladder cancer achieved all primary and secondary endpoints of safety and efficacy.

Conducted in collaboration with Lund University in Sweden and Motol University Hospital in Czechia, the study demonstrated that 80% of tumours responded to Alpha1H, with a 59% average reduction in tumour size among high-dose patients. Data showed that Alpha1H directly induced tumour cell apoptosis, triggered immune activation comparable to Bacillus Calmette-Guérin (BCG) but faster, and downregulated over 700 cancer-related genes including key oncogenes such as RAS and GJA1.

Importantly, no serious adverse events were observed, even after higher or repeated dosing, with side effects limited to mild, local reactions. The results support Alpha1H as a potential neoadjuvant treatment that could reduce tumour burden prior to surgery and avoid the systemic toxicity associated with chemotherapy and immunotherapy.

With an annual global incidence of more than 500,000 non-muscle invasive bladder cancer patients and a market estimated at over USD3bn, Hamlet BioPharma positions Alpha1H as a strong commercial opportunity. The therapy benefits from FDA Fast Track designation and patent protection in key regions.

Hamlet BioPharma is now preparing for regulatory discussions regarding a Phase III study.