SOLANA BEACH, Calif., April 18, 2000 (PRIMEZONE) -- Situs Corporation, a pioneer in intravesical drug delivery, today announced it has received from the US Patent and Trademark Office notices of allowance for both its intravesical drug delivery device, the UROS(tm) Infusor, and the company's proprietary drug for overactive bladder, I-OXY(tm).
The patent allowances follow the company's February announcement that it has initiated human testing of UROS(tm) and I-OXY(tm) involving a Phase I/II placebo-controlled clinical trial to investigate the safety, pharmacokinetics and efficacy of the drug administered via the UROS Infusor(tm) in women with overactive bladder. The company expects to complete these trials and start Phase III studies by year-end and expects to launch the system in the U.S. and Europe in the Fourth Quarter of 2002.
"Receiving these patent approvals further validates our state-of-the-art technology and the fact that we are poised to offer overactive bladder sufferers a greatly enhanced quality of life," said Situs Chief Executive Officer Tate Scott. "In addition, we are hopeful that this system has the potential to treat other chronic and life-threatening conditions, including bladder cancer."
The UROS Infusor(tm) is a unique intravesical drug delivery device designed to provide a continuous flow of drug solution for up to one month. The device itself is a soft-balloon reservoir that is inserted into and removed from the bladder during a simple outpatient office visit that requires only a few minutes. The infusor's site-specific delivery has the potential to provide improved efficacy, reduced side effects, and lower cost.
Currently, approximately 50 million people worldwide, including 17 million Americans, mainly women and the elderly, suffer from overactive bladder, a chronic condition characterized by urgency, frequency or urge incontinence. While nearly $3 billion is spent annually on disposable protection, up to 50% of current oral therapies are not effective or have side effects. The annual societal costs of urinary incontinence exceed $26 billion in the U.S. and are expected to rise significantly as the general population ages.
Situs Corporation is a pioneer of intravesical drug delivery. The company's site-specific drug delivery platform is capable of administering various pharmaceutical compounds for the treatment of local and systemic conditions. Other potential applications of the UROS technology includes chemotherapeutic agents for bladder cancer, hormones for genitourinary conditions, and analgesics for pain. For more information, please visit the company's Web site at www.situscorp.com.