BERKELEY HEIGHTS, NJ - December 8, 2003 -
Genta Incorporated (Nasdaq: GNTA) announced the
presentation of results from several clinical studies that showed
safety and potentially enhanced activity when chemotherapy was
combined with Genasense
TM
(oblimersen sodium) as initial therapy for patients over the age
of 60 with acute myeloid leukemia (AML). Investigators from the
James Comprehensive Cancer Center, Ohio State University,
Columbus, OH, presented the results on Saturday at the annual
meeting of the American Society of Hematology in San Diego, CA.
Bcl-2, the target of Genasense therapy, has been shown to block
the onset of leukemia cell death that would otherwise be
initiated by chemotherapy. Genasense inhibits the production of
Bcl-2 protein and may therefore overcome leukemic cell
resistance. Genta is broadly testing the use of Genasense as a
means of sensitizing cancer cells to chemotherapy.
In the clinical trial reported today, Genasense was given at a
dose of 7 mg/kg over 10 consecutive days - a higher total dose
than has been administered in previous clinical trials.
Escalating doses of chemotherapy drugs (daunorubicin and
cytarabine) were administered for 7 consecutive days beginning on
day 4 of treatment. To date, 29 patients have been treated and
are evaluable for response and safety. Sixteen of these patients
were diagnosed with "secondary" AML that is known to be highly
resistant to conventional treatment. Sixteen of the 29 patients
responded to therapy, with 13 patients achieving complete
remission (CR). Of the 13 patients who achieved complete
remission, 7 had secondary AML. Three additional patients showed
no evidence of leukemia after treatment, but failed to achieve
satisfactory recovery of normal blood counts. No unexpected or
dose-limiting toxicities were observed in patients treated in
this study.
Based on the results of this study, the daunorubicin/cytarabine
chemotherapy regimen will be incorporated into a randomized trial
with or without Genasense in patients with newly diagnosed AML
who are 65 years or older. The trial will be conducted by the
Cancer and Leukemia Group B (CALGB), the largest oncology
cooperative group in the U.S.
"Older patients with AML are notoriously unresponsive to standard
chemotherapy," observed Dr. Loretta M. Itri, Genta's President,
Pharmaceutical Development. "These results were observed in a
very compromised patient population and we are pleased with the
decision of the CALGB to advance this combination into a
randomized clinical trial."
About AML
Acute myeloid leukemia (AML) is a rapidly progressive cancer of
the blood that is characterized by the uncontrolled proliferation
of immature white blood cells, called blasts. The overproduction
of these cells crowds the bone marrow, radically reducing the
body"s ability to form other normal and necessary blood cells.
Remission rates in adult AML are inversely related to age, and
substantially lower remission rates are observed in older
patients. In clinical studies of AML, Bcl-2 expression in
leukemia cells has been correlated with significantly poorer
survival.
About Genasense
Genasense works by inhibiting the 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 and non-randomized clinical
trials, including malignant melanoma, multiple myeloma, chronic
lymphocytic leukemia (CLL), and non-small cell lung cancer. The
Company has initiated the filing of a New Drug Application to the
U.S. Food and Drug Administration for treatment of patients with
advanced malignant melanoma using Genasense plus
dacarbazine.
About CALGB
The Cancer and Leukemia Group B (CALGB) is a national clinical
research group sponsored by the National Cancer Institute. The
Group's Central Office is headquartered at the University of
Chicago and its Statistical Center is located at Duke University.
The CALGB was founded in 1955 with a goal of bringing together
clinical oncologists and laboratory investigators to develop
better treatments for cancer. Since then, CALGB has grown into a
national network of 29 university medical centers, over 185
community hospitals, and more than almost 3000 physicians who
collaborate in clinical research studies aimed at reducing the
morbidity and mortality from cancer, relating the biological
characteristics of cancer to clinical outcomes, and developing
new strategies for the early detection and prevention of cancer.
CALGB research is focused on seven major disease areas: leukemia,
lymphoma, melanoma, and cancers of the breast, lung,
gastrointestinal tract, and genitourinary tract.
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:
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
