Genta and Aventis Announce Termination of Genasense(TM) Expanded Access Program in Melanoma
28 Mai 2004 - 7:00PM
PR Newswire (US)
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/
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