To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Bristol-Myers Squibb Supports Three Major Clinical Studies For Taxol® URL: http://www.pslgroup.com/dg/8BC6.htm Doctor's Guide May 15, 1996
PRINCETON, N.J., May 15, 1996 -- Bristol-Myers Squibb Company (NYSE: BMY) today announced its support for three major multi-center clinical studies of its anticancer drug TAXOL(R) (paclitaxel) in early treatment of breast cancer. The studies, which bring to more than 500 the total number of TAXOL clinical trials supported by the company since 1991, have a combined total enrollment of 6,600 breast cancer patients. Two of the studies, now underway at cancer centers across the United States, are designed to determine the effectiveness of TAXOL on long-term survival when used immediately following surgery. In both studies, randomized groups of previously untreated patients are given a standard regimen (doxorubicin and cyclophosphamide) prior to surgery. TAXOL is then administered to some patients, but not others, following surgery. All patients are then given another drug, Tamoxifen. These are large Phase III clinical trials: The intergroup study by CALGB (Cancer & Leukemia Group B) has an enrollment goal of 3,000 patients; and the intergroup study by NASBP (National Surgical Adjuvant Breast & Bowel Program) has an enrollment goal of 2,400 patients. Bristol-Myers Squibb also is supporting a multi-center Pan European study of TAXOL in the initial treatment of women prior to and immediately following breast cancer surgery. "This study is designed to determine both how TAXOL used in combination with other chemotherapeutic agents affects long-term survival and whether this combination prior to surgery might even increase long term survival while also giving women a better chance to avoid radical mastectomy," said Luca Gianni M.D., Associate Director, Division of Oncology, Instituto Nazionale per lo Studio e la Cura dei Tumori, at Milan, Italy, which is the coordinating center for the study. More than 1,200 patients diagnosed with operable unilateral breast cancer are to be enrolled in this Phase III European cooperative study of TAXOL in neoadjuvant combination chemotherapy. Planned to begin later this year, the randomized study of three groups of patients will compare: 1) treatment prior to surgery with a combination of TAXOL and doxorubicin followed by CMF, a standard treatment (cyclophosphamide, methotrexate and fluorouracil); 2) a regimen of doxorubicin alone followed by CMF; and 3) TAXOL and doxorubicin followed by CMF after surgery. "We are seeing the promise of TAXOL become a reality, as clinical investigators increasingly explore its use in earlier stages of cancer, in combination with other therapies and in treatment of a wide range of cancer types," said Renzo Canetta, M.D., Vice President-Clinical Cancer Research, Bristol-Myers Squibb. Since it was initially cleared for marketing in the U.S. on December 29, 1992, TAXOL has been used in the treatment of hundreds of thousands of patients in both outpatient and hospital settings. It has been cleared for marketing in 65 countries. Approximately 25,000 patients have been enrolled in the 500 clinical studies exploring the drug's use in treatment of several types of cancer including ovarian, breast, lung and head and neck cancer. Adding to the growing body of data on TAXOL are the more than 120 clinical trials started since 1995, two years after the drug's initial availability. "This suggests that not only is TAXOL widely used, but also that medical scientists believe TAXOL has not yet reached its full potential," Dr. Canetta said. "Bristol-Myers Squibb is still investing substantially in the further development of this drug." Dr. Canetta pointed out that the most recent major finding comes from a large scale study by the Gynecologic Oncology Group in the U.S. demonstrating that a first-line regimen combining TAXOL and PLATINOL in treatment of women with advanced ovarian cancer improved survival by 50%. Patients treated with the TAXOL containing regimen had a median survival of 37.5 months, as compared to 24.4 months for patients in the standard arm. This was the first clinical trial in 15 years that has shown a notable improvement in survival for advanced ovarian cancer patients. TAXOL received initial FDA clearance on December 29, 1992, for use after failure of first-line or subsequent chemotherapy for treatment of metastatic carcinoma of the ovary. On April 14, 1994, the FDA cleared TAXOL for use in treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy with the stipulation that prior therapy should have included an anthracycline unless clinically contraindicated. Subsequently, the FDA cleared a Bristol-Myers Squibb supplemental application to enable administration of the drug over 3 hours in treatment of ovarian as well as breast cancer and another application to market TAXOL produced semisynthetically, thus eliminating destruction of Pacific yew trees previously used to produce the drug. The most common side effects of TAXOL therapy included alopecia (hair loss), and neutropenia (low white blood cell count) with and without fever and allergic reactions. Other less common side effects were consistent with those listed in the package insert. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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