Genta Announces New Clinical Trial of Genasense(TM) in Patients With Advanced Breast Cancer
BERKELEY HEIGHTS, N.J., Jun 11, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta
(Nasdaq: GNTA) today announced the initiation of a new clinical trial with its
lead anticancer drug, Genasense(TM) (oblimersen sodium), in patients with
advanced breast cancer. The study will evaluate the safety and efficacy of
Genasense in combination with Taxotere(R) (docetaxel; Aventis) and doxorubicin,
two standard chemotherapy drugs. The trial is being sponsored by the National
Cancer Institute (NCI). The study will be lead by Dr. Francisco J. Esteva,
Assistant Professor of Medicine, and will be conducted at the University of
Texas-M.D. Anderson Cancer Center in Houston, Texas.
Genasense blocks production of Bcl-2, a protein that is highly expressed in
breast cancer and that is believed to contribute to the inherent resistance of
cancer cells to anticancer treatments. By reducing the amount of Bcl-2 in cancer
cells, Genasense may amplify the effectiveness of current types of anticancer
treatment.
In preclinical studies, Genasense has been shown to increase the antitumor
activity of both docetaxel and doxorubicin in several types of cancer. In this
new clinical trial, patients will receive escalating doses of Genasense plus the
docetaxel/doxorubicin combination, which is emerging as a standard of care for
patients with advanced breast cancer. This trial is being conducted pursuant to
Genta's Cooperative Research and Development Agreement (CRADA) with the NCI, and
under a NCI contract entitled "Early Therapeutics Development with Phase 2
Emphasis" with the M.D. Anderson Cancer Center.
"A series of preclinical studies have shown increased activity by using
Genasense plus chemotherapy in breast cancer," commented Dr. Esteva. "In the
U.S. alone, more than 200,000 women will be diagnosed with breast cancer this
year, and approximately 40,000 will succumb to the disease. The opportunity to
improve the outcome for these patients using this novel targeted approach is
very exciting."
Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development noted, "Genta
has a broad program of clinical investigations to determine whether Genasense
can enhance the effectiveness of numerous chemotherapeutic regimens. Along with
randomized trials in non-small cell lung cancer, small cell lung cancer and
prostate cancer, Genasense is also being tested in colorectal cancer,
non-Hodgkin's lymphoma, myeloma, acute and chronic leukemia, and pediatric solid
tumors. We are very pleased to initiate this new program in breast cancer at the
M.D. Anderson Cancer Center."
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. Genasense is currently in multiple, late- stage,
randomized clinical trials including malignant melanoma, multiple myeloma,
chronic lymphocytic leukemia, and non-small cell lung 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
programs that center on oligonucleotides (DNA/RNA-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 expects to launch later this year for treatment of cancer-related
hypercalcemia that is resistant to hydration. For more information about Genta,
please visit our website at: www.genta.com.
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 2002.
SOURCE Genta Incorporated
CONTACT: Joy Schmitt of Genta Corporate Communications, +1-908-286-6449 |
