Genasense(TM) Combination With Chemotherapy Reported Useful in Newly Diagnosed Patients With Small Cell Lung Cancer New Multicenter Randomized Trial is Initiated in Collaboration with the NCI
CHICAGO, Jun 3, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated
(Nasdaq: GNTA) announced the presentation of results from a clinical trial using
the Company's lead anticancer compound, Genasense(TM) (oblimersen sodium), plus
chemotherapy for treatment of patients with small cell lung cancer (SCLC). The
data were presented today at the Annual Meeting of the American Society of
Clinical Oncology (ASCO) by Charles Rudin, M.D., PhD, Assistant Professor of
Medicine at the University of Chicago, who was the principal investigator.
Supported by these results, Genta also announced initiation of a new, randomized
trial in previously untreated patients with extensive-stage SCLC.
The study reported today, which was sponsored by the National Cancer Institute
under a Cooperative Research and Development Agreement with Genta, evaluated
patients with extensive stage SCLC who had not previously received chemotherapy.
Escalating doses of Genasense plus carboplatin and etoposide, two commonly used
chemotherapy agents, were administered to evaluate safety and potential
efficacy. Adverse reactions were similar to those seen in patients treated with
chemotherapy alone. Twelve of 14 patients (86%) who were evaluable for response
achieved a partial response (PR); the remaining 2 patients exhibited stable
disease.
A new randomized study chaired by Dr. Rudin has been initiated in collaboration
with the National Cancer Institute and the Cancer and Leukemia Group B (CALGB).
Similar to the initial trial, the study is being conducted in newly diagnosed
patients with extensive SCLC who will receive carboplatin and etoposide with or
without Genasense. The primary endpoint is to evaluate the proportion of
patients who survive beyond 12 months from the start of treatment.
"From the start, the trial we presented today was intended to provide
preliminary evidence of safety and activity, supporting the initiation of this
new multicenter study," said Dr. Rudin. "Our preliminary results are
encouraging, and we are enthusiastic about the randomized trial within the
CALGB."
About Genasense
Genasense(TM) 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 clinical trials in patients with malignant
melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL) and non-small
cell lung cancer.
About Small Cell Lung Cancer
Lung cancer represents the most common form of cancer in the United States.
Approximately 25% of all patients with lung cancers have a type known as small
cell lung cancer (SCLC), which accounts for approximately 40,000 patients per
year. Compared with other types of lung cancer, SCLC is more likely to be widely
metastatic at the time of diagnosis. Patients whose disease has spread outside
of one side of the chest have "extensive-stage" disease. With current treatment,
patients with extensive-stage disease have a median survival of approximately 10
months and long-term disease-free survival is quite rare with this condition. A
summary of Phase 3 experience with multidrug regimens in patients with
extensive-stage SCLC can be viewed at:
jco.org.
Preliminary studies have suggested that Bcl-2 is expressed in up to 90% of
patients with SCLC. By reducing levels of Bcl-2 within cancer cells, Genasense
may increase the effectiveness of standard chemotherapy in this illness.
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/DNA-based medicines) and small
molecules. Genasense(TM) (oblimersen sodium) is the Company's lead compound from
its oligonucleotide program 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 intends 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. |
