Situs Corporation Licenses Enhanced Efficacy Bladder Cancer Therapy

Solana Beach, California, UNITED STATES


SOLANA BEACH, Calif., April 27, 2000 (PRIMEZONE) -- Situs Corporation today announced a licensing agreement and findings from an international multi-center study involving 230 bladder cancer patients at high risk for recurrence.

The findings show that I-MMC(tm) the product that Situs licensed, can increase the efficacy of a commonly used chemotherapy agent and reduce the recurrence rate of the disease.

The 15-site randomized trial demonstrated that Situs' I-MMC, a novel intravesical product, has significantly higher efficacy than standard mitomycin C (MMC). MMC is the chemotherapeutic agent recommended by the American Urological Association (AUA) for treatment of noninvasive bladder cancer.

"The AUA has concluded that BCG, an intravesical immunotherapy, and MMC, are reliable, evidence-based treatments we can offer our bladder cancer patients," said Rodney A. Appell, Head, Section of Voiding Dysfunction and Female Urology, Cleveland Clinic Foundation. "Situs' I-MMC compares favorably to standard MMC with both a decreased recurrence rate and an increased, disease-free interval for the patients in this study."

Among urologic cancers, bladder cancer is second only to prostate in incidence. Approximately two-thirds of all bladder cancers are considered noninvasive, i.e., tumors confined to the mucosa and those that penetrate somewhat deeper, making it a stage one tumor. Mortality is increasing (nearly 25 percent in 1998) and approximately 55 percent percent of the nearly 55,000 new cases are potential candidates for chemotherapy. Currently, the disease is treated via tumor resection alone or with a resection followed by chemo- or immuno-therapy. Treatment options, however, have a recurrence rate of up to 80 percent and there is a high incidence of side effects. Noninvasive bladder cancer represents a $300 million market opportunity.

The study has been sponsored by the National Cancer Institute, and done in conjunction with The Ohio State University Comprehensive Cancer Center, which collected the data. Jessie Au, Pharm.D., Ph.D., the Distinguished University Professor & Dorothy M. Davis Chair of Cancer Research at the Colleges of Pharmacy, Medicine, and Engineering & Comprehensive Cancer Center was the lead researcher for the study. Situs licensed the patent application and clinical data. The company is planning to file a New Drug Application (NDA) for this product before the end of the year.

Dr. Au said, "After more than ten years of research it is a genuine pleasure to see this work come to fruition. Clinicians will be pleased to have new options for their patients."

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. For more information, please visit the company's Web site at www.situscorp.com.


        

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