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Accession Number:
ADA469217
Title:
1-Alpha Hydroxyvitamin D(5) as a Chemotherapeutic and Possibly Chemopreventive Agent
Descriptive Note:
Final addendum rept. 10 Aug 2004-28 Feb 2007
Corporate Author:
ILLINOIS UNIV AT CHICAGO
Report Date:
2007-03-01
Pagination or Media Count:
241.0
Abstract:
We hypothesized that novel vitamin D analog 1945OHD5 D5 will induce differentiation of dedifferentiated cells and prevent progression of malignancy in women with breast cancer. In 1999-2000, completed preclinical studies in rats showed D5 has no serious toxicity high doses led to reversible hypercalcemic effect. In 2000-2001, we completed preclinical toxicity studies in dogs and D5 synthesis. In vitro studies suggested D5 has no effect on normal breast tissues. In 2001-2002, mechanistic studies performed and reported. In 2002-2003, in vitro studies suggested differential effect of D5 on ER vs. ER- cells and that VDR may partially mediate D5s action. Clinical trial protocols updated for UIC IRB and FDA. In 2003-2004, clinical protocol updated and approved by UIC IRB. Lutheran General Hospital removed from protocol. In 2004, preclinical toxicity studies completed. IND application submitted for FDA approval. FDA approved clinical protocol, withholding patient enrollment, pending clarification of drug product stability data since FDA chemists found several presumed deficiencies in study results. In 2006 pre-IND meeting, FDA approved stability study protocol. Contract was issued to complete required studies, which are underway, with results submitted to FDA. DOD has decided no further cash extension will be allowed and project is to be terminated.
Distribution Statement:
APPROVED FOR PUBLIC RELEASE
