TAR-200 is a drug-device combination product that uses Taris system to release gemcitabine continuously into the bladder over seven days.
Gemcitabine is commonly used to treat multiple cancers alone and in combination with other chemotherapeutic drugs
The study will evaluate whether continuous, local exposure to gemcitabine using TAR-200 is safe and tolerable in patients with intermediate risk NMIBC.
In addition, the study will evaluate the preliminary efficacy and pharmacokinetics in this patient population.
The company, which will carry out the trial at multiple sites in Europe, plans to recruit up to 30 patients after the diagnosis of NMIBC and before transurethral resection of bladder tumors (TURBT).
The firm started the first study with muscle-invasive bladder cancer (MIBC) patients in July.
Taris Biomedical chief medical officer Dr 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.”
Taris Biomedical president and CEO Dr Purnanand Sarma said: “The initiation of a second study of TAR-200 is another substantial milestone for our organization.”
