TARIS® LAUNCHES NEW LiRIS® CLINICAL TRIAL
13 May, 2013
TARIS® Announces Dosing of First Patient in Second Phase 2 Clinical Study of LiRIS® in Interstitial Cystitis
Lexington, MA – April 2nd, 2013 – TARIS Biomedical®, a specialty pharmaceutical company developing innovative, targeted therapies to treat bladder diseases with high unmet medical need, announced today that it has dosed the first patient in its second Phase 2 clinical study with LiRIS®, its novel product candidate, in patients with Interstitial Cystitis (IC). LiRIS® is designed to continuously deliver lidocaine over an extended period directly to the bladder of patients with IC, to relieve the painful and often debilitating symptoms associated with this disease.
“TARIS®’ first Phase 2 study provided important insights into both the disease and the benefit of LiRIS relative to placebo in this patient population. This new study incorporates these learnings,” said J. Curtis Nickel, MD, FRCSC, Professor of Urology, Queens University, Canada, and the trial’s principal investigator. Dr. Purnanand Sarma, PhD, President and CEO of TARIS® said, “We anticipate this new study will provide necessary data that will enable us to design a successful registration program. Interstitial Cystitis continues to be a significant unmet medical need, and we believe our technology can fundamentally change the treatment of this debilitating condition.”
This multi‐center, randomized, double‐blind, placebo-controlled Phase 2 clinical study will evaluate the safety and efficacy of LiRIS® in up to 124 patients with Interstitial Cystitis. Patients who successfully complete the randomized trial will be eligible to participate in a subsequent open-label extension arm where all patients are eligible to receive LiRIS®. TARIS® plans to conduct this study in up to 15 investigational sites in the US and Canada.
In a separate release issued today, TARIS Biomedical® also announced that it has closed a $12.5M financing, led by its existing investors, Flagship Ventures, Flybridge Capital Partners, Polaris Partner and Third Rock Ventures.
In addition to Interstitial Cystitis, TARIS® 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) are complex bladder diseases 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 night time 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. As many as 8 million women in the U.S. alone experience symptoms consistent with IC/BPS (RAND Interstitial Cystitis Epidemiology (RICE) study, 2009; Parsons, 2004), for which only two medications are approved, both associated with significant limitations.
About TARIS Biomedical®
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. TARIS®’ 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 Sc.D. and Michael Cima Ph.D. Based in Lexington, MA, TARIS® is backed by leading venture capital firms Flagship Ventures, Flybridge Capital Partners, Polaris Partners and Third Rock Ventures. For more information, visit: www.tarisbiomedical.com.
Contact:Christopher Searcy, Pharm.D, MBA
Chief Business Officer, TARIS Biomedical®
Media Contact: Gina Nugent