sodium chlorite (HM-001) / HOIST - LARVOL DELTA

A Phase II Study of Intravesical HM-001 in Patients with Non–Muscle-Invasive Bladder Cancer Following Safe Completion of a Phase I Trial (AUA 2026) - P | "Clinical Trial Registry Number: jRCT2051230033.Background: Intravesical therapy following transurethral resection of bladder tumor (TURBT) is the standard of care for non–muscle-invasive bladder cancer (NMIBC); however, currently available intravesical agents, including cytotoxic chemotherapy and bacillus Calmette–Guérin (BCG), are frequently associated with local adverse effects that limit treatment completion and long-term disease control.HM-001 (sodium chlorite) is a novel intravesical agent that generates chlorine dioxide radicals under acidic conditions, selectively inducing cancer cell death...Maintenance therapy consists of weekly instillation for 3 consecutive weeks, repeated every 13 weeks for three cycles.The planned sample size is 30 patients. Safety and efficacy will be analyzed descriptively, and no formal hypothesis testing is planned.Enrollment has just started, and 0 of 30 planned patients have been enrolled at the time of this submission."

Clinical • P1 data • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Evaluation of the Efficacy and Safety of HM001 for the Treatment of Moderate to Severe Cancer Pain: An Exploratory, Single-Arm, Open, Single-Center Study (ChiCTR) - P1 | N=30 | Sponsor: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

New P1 trial • Oncology • Pain

Development of HM-001 as a therapeutic drug for non-muscle invasive bladder cancer (AACR 2024) - "HM-001 is a drug containing sodium chlorite as the active ingredient that is being developed as a drug for non-muscle invasive bladder cancer (NMIBC), and is currently undergoing physician-led clinical trials...In particular, low-grade forms are restricted to low- and intermediate-risk groups. The results of this study show that HM-001 is effective not only for high-risk (including CIS) NMIBC but also for low- and intermediate-risk (low-grade) NMIBC."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Development of a Novel Intravesical Therapy Using Sodium Chlorite (HM-001) for Bladder Cancer: Transition from Preclinical to Clinical trial (EMUC 2024) - "Furthermore, the fact that it is effective against high-grade and low-grade PDX-derived bladder cancer tissues indicates that it may be widely applicable to patients with NMIBC. A Phase I/IIa, multi-center, open-label, investigator-initiated study of HM-001 is currently underway in patients with non-muscle invasive bladder cancer undergoing TURBT."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor