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TAXOL APPROVAL CAPS YEARS OF EFFORT

 WASHINGTON, Dec. 29 /PRNewswire/ -- Taxol (paclitaxel), a drug whose development was spearheaded by the National Cancer Institute (NCI), has been approved by the U.S. Food and Drug Administration (FDA) for treating ovarian cancer that has failed other therapy. The new drug will be marketed by Bristol-Myers Squibb Company (NYSE: BMY).
 Ovarian cancer is diagnosed in about 21,000 women in the United States each year and claims 13,000 lives. Although most patients initially respond to chemotherapy, the cancer often recurs in a form that is resistant to most treatments.
 "Taxol is a very important drug, and I am proud of NCI's role in bringing it to the public," said NCI Director Samuel Broder, M.D. "The Food and Drug Administration and NCI's network of investigators have been exemplary in collaborating to expedite development of this drug," he added. "Taxol is not a cure, but it clearly can help many women with advanced ovarian cancer who have few other options."
 Broder also praised the Department of Agriculture's Forest Service, the Department of the Interior's Bureau of Land Management, and Bristol-Myers Squibb for their cooperation with NCI in developing an adequate supply of taxol, which originally was scarce. These collaborations were made possible by the Federal Technology Transfer Act of 1986, he noted.
 History
 Interest in taxol dates from the late 1960s, when a crude extract of bark from the Pacific yew tree, Taxus brevifolia, which was being tested in a large-scale NCI plant screening program, showed activity against cancer cells growing in culture. In 1971, chemists at Research Triangle Institute in North Carolina, working under an NCI contract, isolated the active component from the extract and named it "taxol."
 As additional quantities of the drug gradually became available, NCI was able to evaluate it in animal tumor systems. Taxol proved active against a number of these tumors, and the institute selected it in 1977 as a candidate for clinical trials.
 However, the sole source of taxol was Pacific yew bark, in which the concentration of taxol is low. Obtaining bark and extracting taxol is costly and time-consuming. These supply problems seriously impeded access to the drug.
 Mechanism of Action
 In 1979, scientists at the Albert Einstein College of Medicine, whose work was partially funded by NCI, reported that taxol had a novel effect on animal cells. They found the drug acted to stabilize fiber-like structures called microtubules that play a key role in the life cycle of cells. In the presence of taxol, cells become clogged with bundles of microtubules and cease to grow and divide.
 This discovery, which suggested that taxol's way of attacking tumors was unique, increased scientists' interest in studying the drug, and NCI intensified its development efforts. Phase I(A) trials were begun in 1983 under the auspices of the institute's Division of Cancer Treatment. In 1985, Phase II trials were undertaken, although their scope was limited because of the restricted drug supply.
 In 1989, clinical investigators at The Johns Hopkins Oncology Center reported that taxol produced partial or complete responses in 30 percent of previously treated patients with advanced ovarian cancer. This surprisingly good result created a stir among cancer researchers and greatly increased demand for the scarce drug.
 Collaborations
 In order to increase supplies of taxol and bring it to market as quickly as possible, NCI announced in August 1989 that it was holding an open competition for a commercial partner to assist in taxol development. Bristol-Myers Squibb was selected in December 1989 as a result of this competition. In 1990, as more taxol became available, Phase III clinical trials began.
 In January 1991, NCI and Bristol-Myers Squibb signed a Cooperative Research and Development Agreement. The agreement stipulated that Bristol-Myers Squibb would procure Pacific yew bark, supply formulated taxol to NCI, seek alternative, renewable sources of the drug, and follow the necessary procedures to obtain approval of taxol by the Food and Drug Administration. In return, NCI agreed to give the company exclusive access to its clinical and pre-clinical data on taxol.
 In 1991, NCI also initiated a series of agreements that enabled the Department of Agriculture's Forest Service and the Department of the Interior's Bureau of Land Management to cooperate with Bristol- Myers Squibb in procuring large quantities of Pacific yew bark.
 Increased Supply
 Taxol supplies increased as a consequence of these agreements, enabling NCI to make the drug available through a special program (Treatment Referral Center) to certain patients with advanced ovarian cancer who were not eligible for other clinical trials. Subsequently, as a result of additional information suggesting that the drug was useful in breast cancer, the Treatment Referral Center expanded its services to include patients with advanced breast cancer.
 Bristol-Myers Squibb registered Taxol as a proprietary name in May 1992. Two months later, the company filed a New Drug Application for Taxol with the FDA, and in December, the FDA approved the drug for treatment of patients with ovarian cancer which had failed previous chemotherapy.
 Like most other cancer drugs, taxol has certain side effects and can cause unpleasant and sometimes dangerous toxicity. However, its risks are outweighed by its potential benefits for certain patients with advanced ovarian cancer.
 Current Trials
 Clinical data, some of which are preliminary, suggest that, in addition to its proven usefulness in treating refractory (treatment- resistant) ovarian cancer, taxol may prove helpful in treating breast, lung, and head and neck cancers. The drug does not appear useful for patients with melanoma, or with colon, prostate, renal, or cervical cancers.
 Trials to determine whether taxol is effective in other cancer types are currently underway. In addition, Phase III trials designed to compare taxol, alone or in combination with other drugs, to standard therapy in ovarian and breast cancer are being planned or are already in progress.
 Because cancer is usually treated with drug combinations, investigators are carrying out additional Phase I trials aimed at developing taxol in combination with other drugs. They are also conducting studies to evaluate and attempt to overcome taxol drug resistance, as well as trials designed to evaluate taxol use in patients with impaired organ function (e.g., heart or liver damage).
 Although many patients with advanced ovarian or breast cancer respond to taxol, these responses are generally partial, rather than complete, and they are limited in duration. Researchers hope that taxol administered earlier in the course of these diseases will prove more effective, and they are conducting trials to determine whether this may be the case.
 Patients who are interested in information on taxol and other treatments for ovarian cancer may call NCI's Cancer Information Service toll-free at 800-4-CANCER (800-422-6237).
 (A) In Phase I clinical trials of a cancer drug, the drug is given to a small number of patients, principally with the aims of learning the best way to administer it and determining how much can be given safely. Phase II trials are aimed at determining which tumor types the drug may be active against. Phase III trials are large-scale trials designed to establish whether or not the new agent is more effective than other therapies against a specific type of caner.
 -0- 12/29/92
 /CONTACT: Elaine Blume, NCI Press Office, 301-496-6641/
 (BMY)


CO: National Cancer Institute; U.S. Food and Drug Administration;
 Bristol-Myers Squibb Company ST: District of Columbia IN: MTC SU:


DC -- DC010 -- 0363 12/29/92 14:12 EST
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