US-based, therapeutically focused urology company TARIS Biomedical has started the Phase Ib clinical trial of TAR-200 to treat non-muscle-invasive bladder cancer (NMIBC).
TAR-200, also known as gemcitabine releasing intravesical system (GemRIS), is a drug-device combination product based on the TARIS system, designed to continuously release gemcitabine into the bladder for seven days.
Gemcitabine is designed to treat multiple cancers individually or while combined with other chemotherapeutic drugs.
The TARIS system is a controlled release dosage using passive delivery principles for a continuous drug delivery to the bladder over weeks and months.
The Phase Ib open-label study has been designed to test the safety and tolerability of a continuous, locally administered gemcitabine using TAR-200 to treat NMIBC.
It will also evaluate the preliminary efficacy and pharmacokinetics profile of the product.
Conducted across multiple sites in Europe, the study is planning to involve 30 patients after being diagnosed with NMIBC and before transurethral resection of bladder tumours (TURBT).
TARIS chief medical officer Christopher Cutie said: “Non-muscle-invasive bladder cancer, which represents 70%-75% of newly diagnosed cases, is a serious disease with a profound impact on the lives of patients.
“The current management of this cancer includes repeated surgical and pharmacological interventions, as well as lifelong monitoring. Despite these efforts, many patients are still at risk of recurrence and, in some cases, progression to MIBC.
“TAR-200 may ultimately offer a unique non-surgical approach in the management of this disease.”
TAR-200 is believed to address bladder cancer with minimal associated side-effects and will address the unmet needs in muscle-invasive and non-muscle-invasive bladder cancer.
Image: Scanned image displaying thickened bladder wall due to cancer. Photo: courtesy of James Heilman, MD.