BERKELEY HEIGHTS, NJ - December 08, 2006-
Genta Incorporated (NASDAQ: GNTA) announced today announced
that the Company has been notified of preliminary results from a
randomized Phase 3 trial of chemotherapy with or without Genasense®
(oblimersen sodium) Injection that was conducted in older,
previously untreated patients with acute myelogenous leukemia.
According to the analysis conducted by the Cancer and Leukemia
Group B, the trial failed to meet its primary endpoint of overall
survival. Further analyses of these data will be submitted for
presentation at a scientific meeting. This study was sponsored by
the Division of Cancer Treatment and Diagnosis, National Cancer
Institute (NCI), under a Cooperative Research and Development
Agreement between Genta and NCI.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer
cells that is thought to block chemotherapy-induced apoptosis
(programmed cell death). By reducing the amount of Bcl-2 in cancer
cells, Genasense may enhance the effectiveness of current
anticancer treatment. Genta is pursuing a broad clinical
development program with Genasense evaluating its potential to
treat various forms of cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA- and DNA- based medicines) and
small molecules. Genasense® (oblimersen sodium) Injection is the
Company's lead compound from its oligonucleotide program. The
Company has submitted a New Drug Application (NDA) to the Food and
Drug Administration for the use of Genasense plus fludarabine and
cyclophosphamide for treatment of patients with relapsed or
refractory chronic lymphocytic leukemia (CLL). Genta has also
completed a Marketing Authorization Application to the European
Medicines Agency (EMEA) for use of Genasense plus dacarbazine for
treatment of patients with advanced melanoma. The leading drug in
Genta's small molecule program is Ganite® (gallium nitrate
injection), which the Company is exclusively marketing in the U.S.
for treatment of symptomatic patients with cancer related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
Safe Harbor
This press release may contain 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. Forward-looking
statements include, without limitation, statements about:
-
the Company's ability to obtain necessary regulatory
approval for Genasense® from the U.S. Food and Drug
Administration ("FDA") or European Medicines Agency
("EMEA");
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the safety and efficacy of the Company's products or
product candidates;
-
the Company's assessment of its clinical trials;
-
the commencement and completion of clinical trials;
-
the Company's ability to develop, manufacture, license and
sell its products or product candidates;
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the Company's ability to enter into and successfully
execute license and collaborative agreements, if any;
-
the adequacy of the Company's capital resources and cash
flow projections, and the Company's ability to obtain
sufficient financing to maintain the Company's planned
operations;
-
the adequacy of the Company's patents and proprietary
rights;
-
the impact of litigation that has been brought against the
Company and its officers and directors;
-
the Company's ability to regain compliance with the
NASDAQ's listing qualifications; and
-
the other risks described under Certain Risks and
Uncertainties Related to the Company's Business, as contained
in the Company's Annual Report on Form 10-K and Quarterly
Report on Form 10-Q.
The Company does not undertake to update any forward-looking
statements. 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 on Form 10-K for 2005 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACTS:
Investor Relations
Tara Spiess/Andrea Romstad
TS Communications Group, LLC
info@genta.com
(908) 286-3980
