Taris Biomedical said today that it closed initial enrollment in its phase Ib clinical trial following positive results. The study is evaluating the safety and efficacy of its drug-device combination product that releases gemcitabine continuously into the bladder for 7 days in patients with muscle invasive bladder cancer.
Although the study was slated to enroll up to 20 patients, the Lexington, Mass.-based company decided to close enrollment after observing promising preliminary results in 8 out of 10 patients. Early data showed that the system was well tolerated over 2 week-long treatment periods, with a 14-day resting period in between treatments. Researchers observed tumor responses such as complete tumor ablation and substantial shrinkage in 8 patients.