UroGen Pharma Receives FDA Fast Track Designation for MitoGel™ for the Treatment of Upper Tract Urothelial Carcinoma (UTUC)
There are currently no drugs approved by the
“Uro-oncology is an area that has seen limited therapeutic innovation over the last several decades,” said Arie Belldegrun, MD, Chairman of UroGen. “UroGen’s broad product pipeline, including MitoGel for UTUC, aims to overcome the limitations and deficiencies of currently available treatment options for these cancers. Importantly, Fast Track designation will help potentially expedite the future regulatory review of MitoGel so we can execute on our goal of bringing this innovative product candidate to market as rapidly as possible.”
The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs to treat serious conditions and fill an unmet medical need. The designation enables early and frequent communication between the
“MitoGel has the potential to become a first-line treatment for low-grade UTUC, sparing patients from invasive surgery as well as the potential risks and complications of kidney removal,” said
Non-muscle invasive upper tract urothelial carcinoma (UTUC) has an estimated annual incidence in
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.
About the OLYMPUS Trial
OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 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 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.
Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the clinical development of MitoGelTM and other product candidates in UroGen Pharma’s pipeline, the OLYMPUS pivotal Phase 3 clinical trial, the Fast Track Designation, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the fact that the grant of Fast Track designation does not guarantee that we will experience a faster development process, review or approval of MitoGel compared to conventional
UroGen Pharma Ltd. Gary TitusChief Financial Officer firstname.lastname@example.org 646-768-9531 Or Burns McClellan, Inc. Steve Klasssklass@burnsmc.com 212-213-0006