SOLANA BEACH, Calif., Oct. 4, 1999 (PRIMEZONE) -- Situs Corp., a leader in the development of alternate drug delivery systems, today announced it is initiating Phase I/II human clinical testing of its proprietary drug for treatment of overactive bladder.
The company said the Investigational New Drug (IND) application for its proprietary compound, I-Oxy(TM), which was filed on August 30, 1999 with the U.S. Food and Drug Administration (FDA), has been approved and Phase I/II clinical studies of the drug may begin this month. The lead investigators in the study include Roger Dmochowski, M.D., Medical Director, The North Texas Center for Urinary Control (Fort Worth, TX) and Timothy Boone, M.D., Ph.D., Associate Professor, Baylor College of Medicine (Houston, TX).
W. Tate Scott, president and chief executive officer of Situs said, "This is a major step forward for Situs in its mission to relieve the debilitating effects of overactive bladder, which affects more than 17 million Americans. This is an affliction that is relatively overlooked, yet more prevalent than most other chronic diseases, including asthma, coronary artery diseases, diabetes mellitus and peptic ulcer conditions."
Rodney Appell, M.D., the chairman of Situs' Scientific Advisory Board and Head of the Cleveland Clinic Foundation's Voiding Dysfunction and Female Urology, said, "I am particularly proud of this achievement, as overactive bladder is the single biggest disease affecting the quality of life in post-menopausal women. The Situs approach is unique and the company's movement toward achieving its ultimate goal is well structured and on target. We look forward to further evaluation of I-Oxy in human clinical studies."
Thom Gunderson, analyst with Piper Jaffrey continued, "Two years ago this company just got started, and to now be ready to begin Phase I/II clinical trials is impressive. This is a company to keep your eye on."
Situs Corporation is a developer of alternate drug delivery systems. 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 Situs system include chemotherapeutic agents for bladder cancer, hormones for genitourinary conditions, and analgesics for pain.