Bone Care International Inc. Announces Final Phase 3 Clinical Trial Results.MADISON, Wis.--(BUSINESS WIRE)--Nov. 3, 1997--Bone Care International Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BCII) today announced the final results from two multicenter Phase 3 clinical trials of oral One-alpha D2, its lead product. These trials were conducted by leading investigators at the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). - Los Angeles (UCLA), the University of Tennessee The University of Tennessee (UT), sometimes called the University of Tennessee at Knoxville (UT Knoxville or UTK), is the flagship institution of the statewide land-grant University of Tennessee public university system in the American state of Tennessee. - Memphis, the University of Mississippi The University of Mississippi, also known as Ole Miss, is a public, coeducational research university located in Oxford, Mississippi. Founded in 1848, the school is composed of the main campus in Oxford and three branch campuses located in Booneville, Tupelo, and Southaven. , and 13 other U.S. medical centers, to examine the efficacy and safety of oral One-alpha D2 as a new treatment for secondary hyperparathyroidism associated with end-stage renal disease End-stage renal disease (ESRD) Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease . The investigators, in presentations during the 30th Annual Meeting of the America Society of Nephrology in San Antonio, concluded that One-alpha D2 appears highly effective and safe in controlling moderate to severe secondary hyperparathyroidism in hemodialysis patients. Abnormally high parathyroid hormone (PTH PTH abbr. parathyroid hormone Parathyroid hormone (PTH) A chemical substance produced by the parathyroid glands. This hormone is a major element in regulating calcium in the body. ) levels were reduced by more than 50 percent in 106 of 120 patients completing at least 16 weeks of treatment with oral One-alpha D2 in both studies; reductions of more than 70 percent occurred in 97 patients. PTH levels were reduced to target levels in 83 percent of these patients. Side effects attributable to One-alpha D2 administration were infrequent and clinically insignificant. Analysis of each study independently yielded identical conclusions regarding the efficacy and safety of oral One-alpha D2. Data from these Phase 3 trials will provide the basis for Bone Care's filing of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the U.S. Food and Drug Administration (FDA) by February 1998. Bone Care International is an emerging pharmaceutical company which is developing improved D hormone therapies, with low toxicity, for hyperparathyroidism, osteoporosis, prostate cancer, breast cancer, and psoriasis. EDITOR'S NOTE: In the word "One-alpha D2," the "2" should be subscript. CONTACT: Bone Care International Dale W. Gutman, 608/274-7533 Fax: 608/277-7534 |
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