Aventis (NYSE:AVE)
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Genta and Aventis Announce Termination of Genasense(TM) Expanded
Access Program in Melanoma
BERKELEY HEIGHTS and BRIDGEWATER, N.J., May 28 /PRNewswire-FirstCall/ -- Genta
Incorporated (NASDAQ:GNTA) and Aventis (NYSE:AVE) today announced the
termination of the Expanded Access Program (EAP) for Genasense(TM) (oblimersen
sodium) Injection in combination with dacarbazine (DTIC).
The decision to close the program was made subsequent to the May 3, 2004,
meeting of the Oncologic Drug Advisory Committee (ODAC), at which the results
of the Genasense Phase III metastatic melanoma trial were discussed. At that
meeting, the committee voted that there was insufficient evidence to recommend
approval at this time.
The companies are working with the FDA to review key issues and to identify
next steps related to further development of Genasense in advanced malignant
melanoma. As previously announced on May 13, Genta withdrew its New Drug
Application for Genasense in advanced malignant melanoma.
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/.
For Genta
This press release contains forward-looking statements with respect to business
conducted by Genta Incorporated. By their nature, forward-looking statements
and forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially.
For a discussion of those risks and uncertainties, please see the Company's
Annual Report/Form 10-K for 2003.
For Aventis
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 "Autorite des marches financiers".
DATASOURCE: Genta Incorporated; Aventis
CONTACT: Joy Schmitt of Genta, +1-908-286-6449, ; or
Marisol Peron, +1-908-243-7592, , or Lisa Kennedy,
+1-908-243-6361, , both of Aventis
Web site: http://www.genta.com/
http://www.aventis-us.com/