The study focuses on Alpha1H, a compound derived from human breast milk. Professor Michael O'Donnell, a leader in urologic oncology at the University of Iowa, initiated the project after reviewing existing clinical data and the drug’s mechanism of action. The trial will operate under an existing Investigational New Drug application, with a protocol amendment currently heading to the U.S. Food and Drug Administration.

Carcinoma In Situ remains a critical challenge in urology, as 30 to 50 percent of patients fail to respond to standard Bacillus Calmette-Guérin immunotherapy. For these individuals, the risk of disease progression is significant. Catharina Svanborg, Chairman of the Board at Hamlet BioPharma, noted that expanding clinical indications to include this patient population allows the team to evaluate the drug's efficacy against a highly resistant form of the disease. The research will be conducted at the University of Iowa’s dedicated phase I/II clinical trials unit, with all results slated for peer-reviewed publication regardless of the outcome.