Bone Care International Updates Status of Clinical Trials With Hectorol in Prostate Cancer Patients.

Business Editors

MADISON, Wis.--(BUSINESS WIRE)--March 9, 2000

Bone Care International, Inc. (NASDAQ: BCII) today provided an update on the clinical investigation of Hectorol Capsules as a treatment for patients suffering from advanced prostate cancer.

The Company reported that a Phase 2 trial in patients with hormone refractory prostate cancer is continuing at the Comprehensive Cancer Center of the University of Wisconsin-Madison, under the direction of Dr. George Wilding, Head of Medical Oncology. The study is examining the effectiveness of Hectorol in slowing or halting the progression of metastatic disease. This study was initiated after a Phase 1 clinical study was successfully completed in this same patient population.

Dr. Wilding presented results from these trials to the Genitourinary Cancer Committee of a national Cooperative Oncology Group which met recently to review concepts for new, large clinical studies for prostate cancer patients. A protocol for a Phase 3 trial was developed by Dr. Michael Carducci, Assistant Professor of Oncology, of Johns Hopkins University for the Genitourinary Cancer Committee. In this trial, Hectorol Capsules will be evaluated as one of three treatments for hormone refractory prostate cancer at 330 U.S. medical institutions. This trial presently is under review by the National Cancer Institute (NCI) for initiation later this year, but there is no guarantee that this protocol will be approved.

Earlier results from the Phase 1 study and the available results from the Phase 2 study were presented by Dr. Wilding at CaPCURE's Sixth Annual Scientific Retreat in October 1999. In the Phase 1 trial, 25 patients with progressive and objectively measureable disease were enrolled in successive cohorts of 3-6 patients and treated with escalating doses of Hectorol. Sixteen of these patients completed at least 12 weeks of treatment and underwent disease re-assessment (by x-rays, CAT scan or bone scan). The majority of these patients showed positive responses to therapy: 2 patients showed disease regression and another 9 showed disease stabilization. Hectorol was generally well tolerated, even at high dosages (up to 15 mcg/day). To date, sixteen patients have been enrolled in the ongoing Phase 2 study, but it is too early to assess the extent of positive responses. Dr. Wilding commented, "The results are encouraging, but a larger study of longer duration is needed."

Bone Care also reported that U.S. Patent No. 5,763,429 has issued. The patent claims the use of Hectorol and many other vitamin D-hormone and D-analog agents as treatments for prostate cancer. Additional applications for patents are pending world-wide for use of these agents in treating prostate cancer and other cancers including those of the breast and colon.

Bone Care is a pharmaceutical company which discovers, develops, and commercializes improved vitamin D-hormone therapies for the treatment of SHP associated with renal disease and osteoporosis, psoriasis, and cancers of the breast, prostate, and colon. Bone Care launched its lead product, Hectorol Capsules, in the U.S. in October 1999 using its own sales force.