SOLANA BEACH, Calif., Jan. 25, 2000 (PRIMEZONE) -- Situs Corp. today announced that it has received FDA approval to begin Phase 1-2 clinical testing of its intravesical drug delivery device, the UROS(TM) Infusor, and the company's proprietary drug for overactive bladder, I-OXY(TM).
The company said the primary objective of this placebo-controlled study is to investigate the safety, pharmacokinetics and efficacy of I-OXY administered via the UROS Infusor in women with overactive bladder.
The UROS Infusor is a novel intravesical drug delivery device designed to deliver a continuous flow of drug solution over a various length of time.
Tate Scott, Chief Executive Officer, said, "We are right on schedule in our testing of both the UROS Infusor and I-OXY. Our previous clinical work has been eminently successful and we anticipate continued success in this study".
Mr. Scott pointed out that human testing should begin within the next 30 days and will comprise 20 patients randomized into one of two groups receiving an Infusor filled with I-OXY or placebo.
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.
The company's first target indication, overactive bladder, affects an estimated 17 million Americans, more than 30 percent of whom cannot tolerate the side effects of oral medications. Other potential applications of the UROS technology include chemotherapeutic agents for bladder cancer, hormones for genitourinary conditions, and analgesics for pain. For further information on Situs Corp., please visit the company's website at www.situscorp.com.