Provectus Biopharmaceuticals has launched a preclinical study of its lead investigational drug PV-10 in an orthotopic bladder cancer model, marking a significant expansion of the company's immunotherapy development program. The study, conducted by Translational Drug Development, LLC (TD2), is expected to deliver results in the first quarter of 2026.
Study Design and Objectives
The preclinical investigation will evaluate PV-10's performance across different treatment arms, including oral and intravesical monotherapy approaches as well as combination therapy with an anti-PD-1 checkpoint inhibitor. The study is specifically designed to generate translational data that would inform future clinical development of PV-10 for bladder cancer and support broader immuno-oncology applications of oral PV-10 for solid tumor cancers.
"Our goal is to be able to translate successful mouse model data into the foundation for a corresponding clinical trial of PV-10 in bladder cancer, with the key being to have an evidence basis for dose and route of administration determinations," said Alan Bryce, MD, Interim President and Chief Clinical Officer at City of Hope Cancer Center Phoenix.
Therapeutic Mechanism and Potential
PV-10 is formulated from Provectus's pharmaceutical-grade rose bengal sodium active pharmaceutical ingredient, representing a first-in-class synthetic small molecule from the halogenated xanthene family. The compound's unique mechanism positions it as a potential game-changing treatment across multiple cancer types.
Dominic Rodrigues, President and Vice Chair of the Board of Directors of Provectus, emphasized the broader implications of the research: "Successful results from this preclinical research will allow us to expand PV-10's investigational new drug application for site-specific and systemic administration. We believe oral PV-10 has the potential to be a game-changing treatment across solid tumor and hematologic cancers."
Company Pipeline and Development Strategy
Provectus Biopharmaceuticals operates as a clinical-stage biotechnology company developing a comprehensive pipeline of immunotherapy medicines based on rose bengal sodium. The company's clinical programs span multiple therapeutic areas including oncology, dermatology, and ophthalmology, with additional proof-of-concept programs in hematology, wound healing, infectious diseases, and tissue repair.
The bladder cancer study represents a strategic expansion of PV-10's potential applications beyond its current clinical development programs, potentially opening new avenues for the compound's therapeutic utility in solid tumor malignancies.
