| Popis: |
Evidence of Taxol's safety and efficacy for treatment of refractory ovarian cancer convinced the National Cancer Institute (NCI) to seek a pharmaceutical partner and approval. After an open competition, NCI entered a Cooperative Research and Development Agreement with Bristol-Myers Squibb Company (BMS) to obtain approval of a New Drug Application (NDA) so that Taxol could be marketed as well as to provide supplies for clinical trials and compassionate use. To assure a successful commercialization of Taxol, BMS developed a strategic plan for expanding drug supplies. The strategy included immediately increasing the amount of Taxol derived from yew bark and establishing a broad research program to evaluate alternative sourcing options and their commercial feasibility. The options included precursor isolation and semisynthesis, yew plantations for biomass production, plant cell culture, and total synthesis. A number of both academic and industrial investigators, already interested in various Taxol supply issues, were enlisted for collaborations with the company. Progress on this research during the first 18 months has enabled BMS to do the following: 1) double the yield of Taxol from bark extraction; 2) exceed NCI's request for drug supplies in 1991, permitting establishment of an ovarian cancer treatment referral center (TRC) with a national network of comprehensive cancer centers; 3) increase NCI supplies from 5000 to 50,000 vials/month in 1992, permitting establishment of TRC protocol for breast cancer; 4) identify several potentially viable alternative sources; 5) schedule production of large amounts of Taxol by precursor conversion during 1993; and 6) ensure that sufficient quantities of the product will be available for treatment and continued clinical research.(ABSTRACT TRUNCATED AT 250 WORDS) |
