UroGen Pharma, a privately held, clinical-stage biopharmaceutical company that is developing advanced non-surgical treatments to address unmet needs in the field of uro-oncology, announced that the first patient has been enrolled in the OLYMPUS trial, an open-label, single-arm pivotal phase III clinical trial of MitoGel, a novel sustained release formulation of Mitomycin C, for the treatment of non-muscle invasive, low-grade upper tract urothelial carcinoma (UTUC).
The OLYMPUS trial design is based on preliminary evidence of the safety and efficacy of MitoGel from an investigator-initiated Compassionate Use program for the treatment of severe, non-resectable, low-grade UTUC. The OLYMPUS trial is being conducted in the United States and Europe with anticipated enrollment of approximately 70 patients. Dr. Seth Lerner, MD FACS, Professor of Urology at Baylor College of Medicine, is the Principal Investigator of this study.
UTUC represents an unmet medical need for which there are no FDA approved drugs. UroGen Pharma has obtained U.S. Orphan Drug Designation for MitoGel for the treatment of UTUC.
Ron Bentsur, chief executive officer of UroGen Pharma, stated, "Enrollment of the first patient into our pivotal study of MitoGel for low-grade UTUC represents an important milestone for the Company. Today, the treatment options for UTUC are a complicated endoscopic surgical procedure or surgical removal of the involved kidney and upper tract. MitoGel, representing a potential non-surgical local treatment for low-grade UTUC patients, may become the first drug ever approved to treat for UTUC.”
Arie Belldegrun, M.D., UroGen Pharma's Chairman, commented, "We are thrilled to have taken an important step towards advancing the development of a potential treatment for low-grade UTUC that may benefit the families and individuals living with this condition. The commencement of the MitoGel pivotal study today highlights our commitment to developing transformative therapies for people suffering from uro-oncological conditions."
OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm phase III clinical trial of MitoGel to evaluate the safety, tolerability and tumor ablative effect of MitoGel in low grade UTUC patients. The trial, designed to be a single pivotal study for the potential approval of MitoGel in low-grade UTUC, is anticipated to enroll approximately 70 patients in clinical sites in the U.S. and Europe. The trial will also evaluate the durability of the tumor ablative effect of MitoGel.