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Two Landmark Studies of Taxotere(R) in Prostate Cancer Highlighted in American Society of Clinical Oncology Plenary Session

26/05/2004 2:00pm

PR Newswire (US)


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Two Landmark Studies of Taxotere(R) in Prostate Cancer Highlighted in American Society of Clinical Oncology Plenary Session BRIDGEWATER, N.J., May 26 /PRNewswire-FirstCall/ -- Aventis announced today that two landmark Phase III studies of Taxotere(R) (docetaxel) Injection Concentrate in men with androgen-independent (hormone-refractory) metastatic prostate cancer have been selected for presentation at the Plenary Session of the 2004 annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA. The abstracts are two of only five selected for presentation during the meeting's plenary session on Monday, June 7, in Hall F of the Ernest N. Morial Convention Center. The plenary session is considered the meeting's premier scientific session, as it features prominent data selected by the ASCO Program Committee. Additional data from a clinical trial about Taxotere(R) involving cancer of the head and neck will also be presented at ASCO. Abstract #3, Monday, June 7, 2:45 - 3:00 PM (CDT), Hall F Results from SWOG 9916, a randomized Phase III multi-center trial comparing Taxotere(R) plus estramustine to mitoxantrone plus prednisone in men with androgen-independent (hormone-refractory) metastatic prostate cancer will be presented by Daniel P. Petrylak, MD, Director, Genitourinary Oncology Program, Columbia Presbyterian Medical Center. The study was conducted in cooperation with the Southwest Oncology Group. Abstract #4, Monday, June 7, 3:00 - 3:15 PM (CDT), Hall F A second presentation given by Mario Eisenberger, MD, Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Kimmel Cancer Center, will feature data from TAX 327, a multicenter phase III trial comparing the combination of Taxotere(R) and prednisone to the current standard treatment regimen of mitoxantrone plus prednisone in patients with androgen-independent (hormone-refractory) metastatic prostate cancer. Abstract #5508, Tuesday, June 8, 11:45 - 12:00 PM (CDT), Room O24 In addition, Jan Baptist Vermorken, MD, PhD, Department of Oncology, University Hospital Antwerp Belgium, will present data from TAX 323, a Phase III clinical trial comparing Taxotere(R) plus cisplatin and infusional 5-fluorouracil to standard cisplatin and infusional 5-fluorouracil in patients with nonresectable, locally advanced, squamous cell carcinoma of the head and neck (LA-SCCHN). About Prostate Cancer Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In the United States, more than 230,000 men will be diagnosed with prostate cancer this year, and more than 29,900 will die of the disease. Current therapy for advanced prostate cancer is hormonal manipulation (i.e., blockage of androgen hormones like testosterone that would otherwise stimulate the growth of prostate cancer cells). However, the effects of this treatment typically last between 24 and 36 months, at which time patients may become refractory to hormonal therapy and be considered candidates for chemotherapy, such as Taxotere(R). About Taxotere(R) Taxotere(R), a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere(R) promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in cancer cell death. Taxotere(R) is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. On May 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere(R) for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer. Among patients receiving Taxotere(R) the most common severe adverse events were low blood cell count, fatigue, diarrhea, and mouth and throat irritation. The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, rash, nail changes, nausea, vomiting, and muscle pain. Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions. Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere(R), visit http://www.taxotere.com/ or see full prescribing information including boxed WARNINGS. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com/. About Aventis Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of euro 16.79 billion (US $18.99), invested euro 2.86 billion (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit: http://www.aventis-us.com/. Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Reference"- on file with the "Commission des Operations de Bourse" in France, recently renamed "Auto rite des marches financiers". DATASOURCE: Aventis CONTACT: Lisa Kennedy, +1-908-243-6361, , or Marisol Peron +1-908-243-7592, , both of Aventis U.S. Product Communications Web site: http://www.aventisoncology.com/ http://www.aventis-us.com/ http://www.taxotere.com/

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