Situs Files Investigational Drug Application for UROS( A New, Innovative Drug Delivery System

Solana Beach, California, UNITED STATES


SOLANA BEACH, Calif., Nov. 2, 1999 (PRIMEZONE) -- Situs Corp., a leader in the development of alternate drug delivery systems, today announced it has filed an Investigational New Drug Application (IND) to initiate a Phase 1-2, randomized, placebo-controlled study of UROS Drug Delivery System, an innovative new way of administering continuous, site-specific treatment for various conditions. This announcement follows the approval of its first IND on September 30, 1999.

The primary objective of this study is to investigate the safety, pharmacokinetics and preliminary efficacy of the drug delivery system compared with a placebo.

Currently, in excess of 17 million women in the United States suffer from a condition called "overactive bladder," a sudden and/or frequent urge to urinate, often leading to "accidents" or incontinent episodes. This condition not only causes physical discomfort but also can lead to psychological conditions including anxiety, depression and sexual dysfunction. W. Tate Scott, President and Chief Executive Officer of Situs, said, "It is astounding just how many people cannot or do not want to take oral medication. Sadly many women who fail oral medications just give up and elect to stay at home rather than risk an embarrassing incontinent episode in public. That's just not acceptable."

UROS Drug Delivery System is an intravesical (bladder) drug delivery system designed to provide 28 days of pharmaceutical treatment to women with overactive bladders. It will offer a convenient, new alternative to treating overactive bladder especially for women intolerant of oral medications.

Scott continues: "This achievement is the culmination of the last two years of work by our team to develop an innovative alternate drug delivery system. We are moving forward on schedule and look forward to successful completion of the study in the first quarter of next year. Furthermore, because our platform technology is highly flexible and adaptable, we are able to address the needs of additional clinical areas such as oncology. Our initial research has revealed some exciting possibilities, which could potentially help millions of people."

Scheduled to begin in November 1999, the study will include approximately 60 patients. The primary investigators will be Timothy Boone, M.D., Associate Professor, Baylor College of Medicine and Philippe Zimmern, M.D., Associate Professor, University of Texas Southwestern Medical Center. Future investigators will include Paul Abrams, M.D., Professor, Bristol Urological Institute, Bristol, England.

"This is an exciting technology which has the potential to establish a new standard in drug delivery for selected patients. I look forward to seeing the results from the studies," commented Alan Wein, M.D., Professor and Chief, Division of Urology, University of Pennsylvania Medical Center.

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.


        

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