21 December 2017 - - Lexington, Massachusetts-based urology therapeutics developer Taris Biomedical LLC, and New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of Taris' investigational product, TAR-200 (GemRIS), in combination with Bristol-Myers Squibb's programmed death-1 immune checkpoint inhibitor, Opdivo (nivolumab), the companies said.
The Phase 1b trial will evaluate the combination in patients with muscle invasive bladder cancer (MIBC) who are scheduled for radical cystectomy. Few options are available to treat MIBC, which may metastasize and often leads to death.
In conjunction with this collaboration, Bristol-Myers Squibb has made an equity investment in Taris.
The Taris System, deployed and retrieved using minimally-invasive, in-office procedures, is designed to continuously release drugs in the bladder over weeks to months.
TAR-200, the company's lead investigational program in bladder cancer, is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over seven days.
Taris Biomedical is building a therapeutically-focused urology company, developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases. The company is advancing therapies for debilitating conditions, including bladder cancer and overactive bladder, enabled by continuous local dosing.
Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. Opdivo's leading global development program includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide. The company offers chemically-synthesised drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).