TARIS Successfully Completes Phase 1 Study of Intravesical Drug-Device Convergence System
News Dec 03, 2009
TARIS Biomedical has 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.