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TAXOL CANCER THERAPY FAVORED AS NEXT CANDIDATE FOR NCI GROUP C/TREATMENT IND

Executive Summary

TAXOL CANCER THERAPY FAVORED AS NEXT CANDIDATE FOR NCI GROUP C/TREATMENT IND status, National Cancer Institute Division of Cancer Treatment Director Bruce Chabner told the DCT's Board of Scientific Counselors June 4. "The feeling is," Chabner commented, "that it should be available in the near future for people who have failed platinum therapy for advanced ovarian cancer." Chabner said support for making the anti-cancer drug more widely available stems from recent data on taxol's effectiveness in treating breast, non-small cell lung, and ovarian cancer released at the annual meeting of the American Society of Clinical Oncology in May. At the ASCO conference, Tate Thigpen, et al., University of Mississippi, presented results from a Phase II trial of taxol as a second-line therapy for ovarian carcinoma. The study found an overal 36% remission rate in 41 patients previously treated with cisplatin-based chemotherapy. Of the 15 remissions, five were complete ("The Pink Sheet" June 4, p. 2). A separate study presented at the ASCO conference by Rowinsky, et al., Johns Hopkins Oncology Center, showed positive effects of taxol and cisplatin combinations on a number of neoplasms, including those in the ovary and lung. * Chabner also announced that NCI and Bristol-Myers Squibb will enter a Cooperative Research and Development Agreement (CRADA), which is expected to be signed in the near future. Under the arrangement, the pharmaceutical company will receive exclusive rights to the source data from Phase III clinical trials. However, the NCI official emphasized that the group C status will be delayed because of limitations in supply of the drug, which is derived from the bark of the slow-growing taxus brevifolia tree found in the Northwest and Canada. Chabner said that although NCI has enough taxol to conduct Phase II clinical trials currently in progress, the institute does not have enough supplies to make the drug available for Group C. In an effort to increase supplies of taxol, NCI's Michael Grever said that the institute has formed a task force to look at the supply program. According to Grever, "the best solution" to the shortage could be the future development of an analog to taxol. He said the task force advocates restoring some of the cuts made to grants for production of a synthetic version of the drug. NCI will hold a workshop on the development and short-term and long-term supply of taxol on June 26. The board also approved a request for applications for biological and chemical studies of taxol. The study would be funded at $1 mil. for a five-year period. Of particular interest are areas such as: total chemical synthesis; plant tissue compound to produce taxol and related compounds; agronomics and plant genetics; human metabolism of taxol and in vivo evaluation of combination therapy using taxol in preclinical models.

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