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.
“The results of this study are very exciting,” principal investigator Dr. Siamak Daneshmand said in prepared remarks. “TAR-200 appears to be remarkably well-tolerated in patients who have recently undergone extensive transurethral resection of the bladder. Moreover, the unexpected activity observed in these heavily diseased subjects in just 28 days indicates the significant potential of this product in a broad population of patients with MIBC, often a very difficult disease to treat.”
The Taris system is a controlled-release device, which uses a dual-lumen silicone tube to continuously release gemcitabine. The combination product has a superelastic wireform to impart shape and change between a linear form for insertion and a “pretzel” shape in the bladder.
“Taris is extremely excited about the compelling results from this study, and plans to rapidly advance the product into later-stage clinical trials in bladder cancer in 2017,” Taris president & CEO Purnanand Sarma added. “The tumor response we have seen to date suggests TAR-200 may offer a fundamentally new treatment option for patients with MIBC, where the current standard of care includes bladder removal. We share the excitement of the study investigators about the potential impact that TAR-200 may have on the lives of patients across the spectrum of bladder cancer.”