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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/