Posted Date: 4/10/2017

UroGen Pharma Announces Enrollment of First Patient in Phase III Clinical Trial

UroGen Pharma Ltd. recently announced 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 US 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 US Orphan Drug Designation for MitoGel for the treatment of UTUC.

"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,” said Ron Bentsur, Chief Executive Officer of UroGen Pharma.

"We are thrilled to have taken an important step toward 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," added Arie Belldegrun, MD, UroGen Pharma's Chairman.

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 US and Europe. The trial will also evaluate the durability of the tumor ablative effect of MitoGel. Learn more about the OLYMPUS trial at www.clinicaltrials.gov.

Utilizing RTGel, UroGen's proprietary sustained-release, hydrogel-based formulation, MitoGel is designed to enable longer exposure of Mitomycin C to the urinary tract tissue, thereby potentially enabling the treatment of tumors by non-surgical means. MitoGel is administered to patients using standard intravesical catheters.

Non-muscle invasive upper tract urothelial carcinoma (UTUC) has an estimated annual incidence in the US of up to 7,500 cases – about 5% to 10% of all new cases of urothelial cancer. There are approximately 2,500 new cases of low-grade UTUC in the US with a prevalence of approximately 14,500. UTUC refers to cancer of the upper tract, which connects the bladder to the kidney, and the renal pelvis. The current standard of care for this cancer is complete or partial surgical removal of the involved kidney and upper tract.  For patients with a bilateral disease, an anatomic or functionally solitary kidney, medical comorbidities or low-grade disease that present with a limited number of tumors, a kidney-conserving alternative is considered, if possible. However, due to the specific anatomy and physiology of the upper tract and renal pelvis, the performance of organ-sparing endoscopic resection and instillation of neoadjuvant or adjuvant chemotherapy are often challenging, leading to high rates of recurrence and risk for progression. Difficulties in administering and maintaining Mitomycin C or any other drug in the upper tract due to low residual duration and short exposure time of the active agent in the treated area results in low treatment efficacy and  limited use of chemoablative agents in patients with UTUC.   Furthermore, there are currently no FDA-approved drugs for the treatment of UTUC.

UroGen Pharma is a clinical-stage biopharmaceutical company developing advanced non-surgical, local treatments to address unmet needs in the field of urology, with a focus on uro-oncology. The company has developed RTGel, a proprietary sustained-release, hydrogel-based formulation for potentially improving the efficacy and safety profiles of existing drugs. UroGen Pharma's sustained-release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen Pharma's lead product candidates, MitoGel and VesiGel, are designed to potentially remove tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade UTUC and bladder cancer. Moreover, UroGen Pharma has recently completed a worldwide licensing agreement with Allergan Pharmaceuticals International Limited, a wholly owned subsidiary of Allergan plc, for the use of RTGel with neurotoxins for the treatment of overactive bladder and related conditions. UroGen Pharma is headquartered in Israel and also maintains a corporate office in New York City.

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