TARIS Biomedical, a specialty pharmaceutical company pioneering the field of drug-device convergence for targeted therapies, announced the successful completion of a Phase 1 clinical study of its intravesical drug-device convergence system designed to provide sustained-release of drug directly to the bladder. The study was designed to evaluate the safety, tolerability and retention of the TARIS drug-device convergence system in the bladder. The detailed results have been embargoed pending scientific publication.

"In just one year we have rapidly advanced this technology from in-licensing through Phase 1 human clinical testing," said Christine Bunt, co-founder and COO of TARIS Biomedical. "This Phase 1 study successfully establishes proof-of-concept for the TARIS sustained-release technology and positions us for mid-stage clinical development with our LiRIS (Lidocaine Releasing Intravesical System) in interstitial cystitis (IC), our first indication, in 2010."

A major challenge in the treatment of bladder diseases is the delivery of therapeutic agents at sufficient concentrations for the amelioration of bladder symptoms while minimizing systemic adverse effects. While intravesical instillation of therapeutic solutions is a clinically practiced standard of care, effectiveness is limited by its duration of effect, often requiring multiple dosing regimens. The TARIS core platform technology, which was developed by MIT, enables local sustained delivery of drug directly to the target tissue through drug-device convergence.

"The success of this early study is a significant milestone for TARIS. It validates the core platform technology and opens up the potential of this drug-device convergence system, beyond IC, into a variety of bladder diseases such as bladder cancer and overactive bladder," said Robert S. Langer, PhD, David Koch Institute Professor at the Massachusetts Institute of Technology and co-founder of TARIS Biomedical.

About the LiRIS System

TARIS is focusing its development efforts in disease areas with high unmet need in which current therapies or systemic treatments have failed. TARIS has developed a lidocaine-releasing intravesical system (LiRIS) that supplies a sustained release of lidocaine directly to the bladder. Lidocaine has been shown in scientific literature and clinical practice, to decrease symptoms associated with bladder diseases, such as bladder pain and urgency when instilled directly into the bladder. Bladder diseases, which are difficult to treat with systemic therapies, affect 50 million people in the U.S. alone. These diseases include interstitial cystitis (IC)/painful bladder syndrome (PBS), bladder cancer, overactive bladder, urinary tract infections and chronic pelvic pain syndrome.

About IC/PBS

IC/PBS, a bladder disease associated with significant pain and disability, as well as urinary urgency and/or frequency, will be the initial therapeutic area of focus for TARIS. People with severe cases of IC/PBS may urinate 25-60 times a day, including frequent nighttime urination, also called nocturnia. IC/PBS can dramatically impact quality of life, including loss of work and reduced sexual intimacy. IC/PBS is associated with suicidal rates five-to-seven times the national average. New therapeutic options for IC/PBS are desperately needed. Over four million people in the U.S. alone suffer from IC/PBS (National Institutes of Health, Rand Interstitial Cystitis Epidemiology (RICE) study 2009), for which only two medications are approved, both associated with significant efficacy limitations.

TARIS Biomedical

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