TARISTM Initiates Phase 2 Clinical Study with LiRIS® in Interstitial Cystitis Patients
LEXINGTON, Mass.--(BUSINESS WIRE)--TARIS Biomedical, Inc., a specialty pharmaceutical company pioneering the development of innovative, targeted therapies using drug delivery to treat bladder diseases with high unmet medical need, announced that it has initiated a Phase 2 clinical study with its novel product candidate, LiRIS®, in patients with Interstitial Cystitis. LiRIS® is designed to continuously deliver lidocaine over an extended period directly to the bladder to relieve symptoms associated with Interstitial Cystitis, such as bladder pain and voiding dysfunction.
This multi-center, randomized, placebo controlled, double-blind Phase 2 clinical study of LiRIS® in up to 161 women with Interstitial Cystitis will evaluate the impact of LiRIS® on Interstitial Cystitis-related symptoms such as bladder pain, urgency, voiding frequency and overall well-being. TARIS plans to conduct this study at investigational sites in the US and Canada. More information about this trial and enrollment criteria can be found at www.clinicaltrials.gov.
"LiRIS®, TARISTM' lead product candidate, has the potential to fundamentally change the treatment of Interstitial Cystitis, through its innovative continuous delivery design," said Purnanand Sarma, Ph.D., President and CEO, of TARIS Biomedical®. "The initiation of this Phase 2 clinical study with LiRIS® in patients with Interstitial Cystitis builds upon previously completed Phase 1 and 1B studies. Data from the Phase 1B study in moderate-to-severe IC patients will be presented at an upcoming scientific conference in 2012."
"We eagerly look forward to further evaluating the potential of LiRIS® for the treatment of Interstitial Cystitis, an indication with limited therapeutic options," commented J. Curtis Nickel, MD, FRCSC, Professor of Urology, Queens University, Canada, the study's principal investigator.
In addition to Interstitial Cystitis, TARISTM is developing a pipeline of novel, targeted therapies designed to treat a variety of bladder diseases, such as bladder cancer and urinary incontinence, utilizing its novel targeted bladder delivery system.
About Bladder Disease
Bladder diseases, which are difficult to treat with systemic therapies, affect 60 million people in the U.S. alone. These diseases include Interstitial Cystitis (IC)/Bladder Pain Syndrome (BPS), bladder cancer, overactive bladder, urinary tract infections and chronic pelvic pain syndromes.
About Interstitial Cystitis (IC) / Bladder Pain Syndrome (BPS)
Interstitial Cystitis (IC)/Bladder Pain Syndrome (BPS), is a complex bladder disease associated with significant pain and disability, as well as urinary urgency and/or frequency. People with severe cases of IC/BPS may urinate 25-60 times a day, including frequent nighttime urination, also called nocturia. IC/BPS can dramatically impact quality of life, including loss of work and reduced sexual intimacy; it is associated with suicidal rates five-to-seven times the national average. New therapeutic options for IC/BPS are desperately needed. It is estimated that 3 to 8 million women in the U.S. alone experience symptoms consistent with IC (Berry, et al. 2011), for which only two medications are approved, both associated with limited benefit. More information on IC/BPS for patients and physicians is available through the Interstitial Cystitis Association (http://www.ichelp.org/) and the Interstitial Cystitis Network (http://www.ic-network.com/).
About TARIS Biomedical, Inc.
TARIS Biomedical® is a clinical stage specialty pharmaceutical company focused on developing a pipeline of innovative treatments for bladder diseases. Current therapies for these conditions are characterized by limited efficacy and/or systemic side effects. TARIS Biomedical®'s delivery platform is designed to improve treatment by providing controlled, sustained delivery of drug directly to target tissues. TARISTM's most advanced product candidate, LiRIS®, is currently in Phase 2 clinical development for the treatment of Interstitial Cystitis.
TARIS Biomedical®'s technology was developed by internationally renowned scientists from the Massachusetts Institute of Technology, Robert Langer and Michael Cima. Based in Lexington, MA, TARISTM is backed by leading venture capital firms Flagship Ventures, Flybridge Capital Partners, Polaris Venture Partners and Third Rock Ventures. For more information, visit www.tarisbiomedical.com.
Christopher Searcy, Pharm D, MBA, 781-676-7750
Chief Business Officer
for TARIS Biomedical
Gina Nugent, 617-460-3579