Chemosensitizing Drug is Subject of First NDA for Systemic
Antisense Therapy
BERKELEY HEIGHTS, NJ - December 9, 2003
-Genta Incorporated (Nasdaq: GNTA) announced that the Company
completed the submission of its New Drug Application (NDA) for
Genasense
TM
(oblimersen sodium) used in combination with dacarbazine for the
treatment of patients with advanced malignant melanoma on December
8, 2003. The application process, which began in the 3rd quarter of
this year, was submitted under the Fast Track program of the U.S.
Food and Drug Administration (FDA) that is designed to expedite
review of new drugs that address important unmet medical needs. The
Company has requested designation of the Genasense NDA for Priority
Review. Applications that are granted priority review are usually
targeted for action by the FDA within six months from the date the
submission is completed.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer
cells that is thought to block chemotherapy-induced cell death. By
reducing the amount of Bcl-2 in cancer cells, Genasense may enhance
the effectiveness of current anticancer treatments. Based on
preclinical and clinical studies that demonstrate anti-tumor
effects in a broad range of cancers, Genta is studying Genasense in
multiple, late-stage randomized and non-randomized clinical trials,
including multiple myeloma, chronic lymphocytic leukemia, non-small
cell lung cancer, small cell lung cancer, and prostate cancer.
About Malignant Melanoma
Malignant melanoma is the most deadly form of skin cancer. The
incidence of this disease is increasing by approximately 4%
annually in the US. In 2003, the American Cancer Society estimates
more than 54,000 cases of malignant melanoma will have been
diagnosed. Melanoma is the number one cause of cancer death in
women aged 25 to 29.
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
TM
(oblimersen sodium), the Company's lead compound from its
oligonucleotide program, is being developed with Aventis and is
currently undergoing late-stage, Phase 3 clinical testing. The
leading drug in Genta's small molecule program is Ganite
TM
(gallium nitrate injection), which the Company is exclusively
marketing in the U.S. for treatment of patients with cancer-related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
This press release and the conference call to follow 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. 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 2002.
SOURCE: Genta Incorporated
