|View printer-friendly version|
|UroGen Pharma Announces First Patient Enrolled in Allergan Phase 2 Clinical Trial of RTGel™ in Combination with BOTOX® for the Treatment of Overactive Bladder|
“The enrollment of the first patient in the Phase 2 clinical trial marks another important milestone in our collaboration with
About the Phase 2 Clinical Trial
The trial is a multi-center, randomized, double-blind, placebo-controlled, single-treatment, two-stage, dose-finding clinical trial on patients with overactive bladder with urgency urinary incontinence who have an inadequate response to or are intolerant to pharmacologic therapy. The first stage of the trial is a placebo-controlled, dose escalation design, followed by the second stage, a randomized, placebo-controlled design. Up to 335 patients are expected to be enrolled. Patients will receive a single bladder instillation of RTGel™ in combination with BOTOX®. The primary efficacy endpoint is the improvement of overactive bladder symptoms as measured by the reduction in urinary incontinence episodes per day.
Learn more about the trial at http://www.clinicaltrials.gov.
About Overactive Bladder and RTGelTM
Overactive Bladder (OAB) is a common, often disabling condition associated with considerable negative impact on quality of life. OAB results in an uncontrolled urge to urinate, frequent urination, and, in many patients, uncontrollable leakage of urine. Standard first-line pharmacologic treatment for OAB is anticholinergic pills. However, the majority of patients stop taking the pills within one year due to an inadequate response to, or intolerance of, the medication. BOTOX® injection into the bladder is approved as a therapy for OAB.
Over 30 million people in
RTGel™ has thermo-sensitive properties that enable it to convert from a liquid state when cold, into a gel once it reaches body temperature. This allows increased residence time of drugs when mixed with the gel and instilled in the bladder.
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 RTGelTM in combination with BOTOX® for the treatment of overactive bladder and other product candidates in UroGen Pharma’s pipeline, the potential of the RTGel™/BOTOX® combination to treat patients with overactive bladder, and the potential utility and applicability of the RTGel™ technology beyond uro-oncology and overactive bladder, 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 ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of the final prospectus for UroGen Pharma’s initial public offering of securities in