Taris launches another Phase I trial for bladder cancer drug-device combo

Taris Biomedical said today it is launching a new phase I trial of its TAR-200 gemcitabine releasing intravesical system designed to deliver drugs directly to the bladder for patients with non-muscle-invasive bladder cancer.

The phase 1b open-label study is slated to enroll 30 patients to explore whether continuous, local exposure to gemcitabine using TAR-200 is safe and tolerable in patients with intermediate risk non-muscle-invasive bladder cancer, the Lexington, Mass.-based company 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,” chief medical officer Dr. Christopher Cutie said in a press release.

The study will be conducted in Europe, and is the 2nd phase 1b trial of the TAR-200 for treating bladder cancer, Taris Biomedical said.

“The initiation of a second study of TAR-200 is another substantial milestone for our organization. If successful, these two studies are designed to demonstrate the potential utility of TAR-200 across the entire spectrum of bladder cancer. We are very excited to advance these programs into the clinic and look forward to the results,” CEO Purnanand Sarma said in prepared remarks.

The deal comes 2 years after the company sold its Liris bladder treatment to Allergan in a deal worth up to $588 million.

In October, Taris said it raised another $32 million to put toward the implant. Taris said it’s planning to investigate other treatments using the same implant used in Liris, funded with a $32 million round led by prior backer Flagship Ventures, joined by existing investor Polaris Venture Partners and a new backer, RA Capital Management.

Taris also built out its board and and clinical operation, naming Flagship Ventures managing partner Ed Kania, former Allergan exec Kevin Finney and ex-Civitas CEO Mark Iwicki to its board. The YY-based company also tapped Dr. Christopher Cutie, M.D., of the Mass. General Hospital, to be vice president of clinical development.

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